Postoperative assessment of monocular multifocal bi-aspheric ablation pattern for correcting myopia with presbyopia

Postoperative assessment of monocular multifocal bi-aspheric ablation pattern for correcting myopia with presbyopia | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Postoperative assessment of monocular multifocal bi-aspheric ablation pattern for correcting myopia with presbyopia Li Li, Xiaofan Wang, Hongsheng Bi, Xingrong Wang, Hua Fan, Peng Ji This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5995145/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose : This study aimed to evaluate the vision performance of the monocular multifocal bi-aspheric ablation pattern (PresbyMAX® monocular mode) for correcting myopia and presbyopia. Methods: Consecutive case series, a total of 22 consecutive patients (10 males and 12 females) who underwent multifocal bi-aspheric ablation in the non-dominant eye(Near vision Eye, NE) and mono-focal regular FS-LASIK in the dominant eye(Distance vision Eye, DE) for correction of myopia and presbyopia were reviewed for 6 months. Visual acuity assessments, encompassing uncorrected distance (UDVA), intermediate (UIVA), near (UNVA), and distance corrected near visual acuity (DCNVA), were conducted preoperatively and at 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively. Additionally, the patients' primary complaints, contrast sensitivity (CS), defocus curves, and subjective questionnaires were also assessed. Results: Binocular UDVA (BUDVA) averaged -0.02±0.06 logMAR, binocular UIVA (BUIVA) and binocular UNVA(BUNVA) at -0.07±0.05 logRAD and -0.05±0.06 logRAD, respectively. All patients achieved BUDVA of 0.1 logMAR or better, BUIVA of 0 logRAD or better, and BUNVA of 0.1 logRAD or better, along with improved subjective ratings.CS exhibited no significant changes. Defocus curves indicated satisfactory visual acuity, with visual acuity surpassing 0.3logMAR for both eyes within the range of +1.5D to -3.0D. Common reported issues included blurred vision, glare, and dry eye symptoms. Overall, patient satisfaction was reported at 100%, with 95% of individuals achieving independence from spectacles. Conclusions: The PresbyMAX monocular ablation mode is safe and effective for myopic patients with presbyopia, leading to high levels of patient satisfaction. presbyopia presbyLASIK visual acuity Multifocal Bi-aspheric Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Introduction Presbyopia is defined as occurring when the physiologically normal age-related reduction in the eye‘s focusing range reaches a point that, when optimally corrected for distance vision, the clarity of vision at near is insufficient to satisfy an individual’s requirements [ 1 , 2 ] . The global prevalence of presbyopia was 24.9% in 2015, and it is expected that 24.1%(2.1 billion) of the population will suffer from presbyopia in 2030 [ 3 ] . In some developing countries, more than 50% of the population lack sufficient near correction, while in developed countries, up to 34% face the same problem [ 4 – 7 ] . Uncorrected presbyopia significantly diminishes quality of life, the treatment of presbyopia gradually become a huge challenge for the eye doctor [ 8 ] . Currently, various methods exist to address presbyopia, yet there is no recognized best scheme [ 1 , 9 , 10 ] . Compared with intraocular surgery, corneal refractive surgery because of its small invasive, more popular with the patients and eye doctor. Frequently employed techniques, including monocular vision, multifocal ablation, Q-value adjustment, and aberration optimization, are typically integrated into corneal refractive surgery. Cornea has been found can partly compensate the loss of accommodation due to the crystalline lens stiffen with aging by special cornea surface ablation, such as creation of a multifocal optical profile. The treatment method for presbyopia that employs LASIK technology to create a multifocal corneal shape is known as "PresbyLASIK.". This method is mainly categorized into Central PresbyLASIK (central near vision) [ 11 ] and Peripheral PresbyLASIK (peripheral near vision) [ 12 ] . Central PresbyLASIK is more aligned with the normal physiological state of the human eye, it involves less corneal ablation compared to peripheral PresbyLASIK. It introduces negative spherical aberration while minimizing other higher-order aberrations, making it more broadly applicable in clinical practice [ 13 ] . PresbyMAX (Schwind Eye-Tech-Solutions GmbH and Co., Kleinostheim, Germany) is a central presbyLASIK technology that combines the treatment of presbyopia and ametropia with the bi-spherical ablation profile using the Schwind AMARIS excimer laser system, which works by creating a central convex corneal shape and the controlled induction of negative spherical aberration combined with the induction of a low amount of myopia, thereby decreasing patients' reliance on spectacles [ 14 , 15 ] . The system has experienced several mode updates. In the present study, the PresbyMAX® monocular mode was employed for bi-aspherical optimized multi-focus ablation, targeting a diopter of -0.89D for non-dominant eyes. Additionally, conventional single-focus FS-LASIK ablation was utilized, with a target diopter of 0.00D for dominant eyes. Previous studies have reported on the visual acuity and visual quality of patients after this surgical [ 16 – 18 ] , but the quantity of published research is limited. Since presbyopia is primarily a functional issue, greater emphasis should be placed on subjective experiences and daily performance. This study aims to evaluate the efficacy following treatment with the excimer laser micro-monovision multifocal non-spherical ablation pattern through assessments of visual acuity, contrast sensitivity, defocus curves, and questionnaires. Materials and methods Ethical Approval This study is a consecutive case series conducted at a single center and follows the guidelines set forth in the Declaration of Helsinki. It has been approved by the Ethics Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine (HEC-KS-2020003KY), registered with the Chinese Clinical Trial Registry under the number "ChiCTR2300074821," and written informed consent was obtained from all study participants. Patients Patients meeting the following criteria were included in the study: aged 40-55 years, diagnosed with bilateral presbyopia and possessing healthy crystalline lenses. Spherical power : -0.50 to -8.00D; cylinder ≤ 4.0D; UNVA ≤20/50, with corrected near visual acuity (CNVA) improved by at least 1 line; CDVA ≥20/25. Photopic pupil between 2.5 and 3.5 mm, and Scotopic pupil diameter＞4.5 mm. Corneal curvature between 40 and 48D. Corneal spherical aberration(6mm)> 0μm, whole eye > -0.2μm; corneal higher-order aberration (6mm) mean square < 0.5μm. The possibility of wearing glasses postoperatively is acceptable. Exclusion criteria are as follows: systemic illness, previous ocular surgery, abnormal corneal topography or biomechanical, clinically relevant lens opacity, any signs of binocular vision anomalies at distance and near and a pupil offset of 0.7 mm or more, professionals engaged in tasks that require precision and fine motor skills, intolerance to the preoperative anisometropic test at least 1.0D. Preoperative Assessments In conjunction with the standard preoperative assessment, additional evaluations were conducted, including an assessment of visual function, contrast sensitivity, defocus curve, monocular vision test, and the questionnaires, utilizing the National Eye Institute 25-item Visual Function Questionnaire(NEI VFQ-25, 2000 version) and the Near the Activity Visual Questionnaire(NAVQ). The dominant eye was determined through a "hole test," with repeated checks until two consecutive results are identical. The monovision test regulates the binocular refractive difference to be between 1.0D and 1.5D, guaranteeing that the dominant eye receives complete visual correction. If the dominant eye's UDVA ≥20/25, only the non-dominant eye will undergo treatment. The Sirius tomograph and corneal topographer (Schwind eye-tech-solutions, software version 2.6.3, Kleinostheim, Germany) was used to capture corneal data for surgery design and to obtain pupil data at photopic, mesopic and scotopic conditions. To ensure optimal corneal data and patient alignment, only high-quality acquisitions of corneal tomography were utilized for surgical design. These acquisitions must meet specific criteria, including the successful passed of the static cyclotorsion component (SCC) check and the attainment of the 14th Placido circle, which provides approximately 7 mm of coverage as a minimum requirement. Surgical Technique All surgeries were performed by the same operator (JP) between January 2023 to March 2024. Preoperative routine disinfection and local anesthesia. A VisuMax femtosecond laser (Carl Zeiss Meditec AG, Jena, Germany) was utilized to create a corneal flap with a thickness of 100μm and a diameter of 8.10mm, with a 60° edge cutting angle and the hinge located at 90°. Following the flap creation, the Schwind AMARIS 1050RS excimer laser platform (Schwind eye-tech-solutions GmbH, Kleinostheim, Germany) was employed for stromal ablation. The dominant eye underwent ablation using the Aberration-Free mode receives complete visual correction. The non-dominant eye received treatment with the monocular-presbyopia mode from the PresbyMAX module, which automatically adjusts the central near vision area (0 to 3mm) based on the original refractive error correction. This creates a prominent multifocal aspheric profile within the central 3mm zone, influenced by the near addition amount—higher additions result in more forward protrusion at the center. Additionally, the transition area between near and distance vision was optimized asphericly to ensure a smooth transition between the two. Both the flap and the ablation profile were centered on the corneal vertex determined at the Sirius corneal topography instrument (Schwind eye-tech-solutions GmbH, Kleinostheim, Germany), which closely approximates the visual axis. The planned addition for the non-dominant eye is between +1.75D and +2.50D. The target diopter of the dominant eye was 0.00D, and that of the non-dominant eye was -0.89 D. The optimal transition zone and ablation amount were calculated according to age, preoperative diopter and optical treatment zone. Outcome Measures The main outcome measures were accuracy, efficacy, safety, and stability. Patients were reviewed at 1day, 1week, and 1month, 3month and 6month after surgery, record monocular and binocular UDVA, CDVA, UIVA, and UNVA. The Standard Logarithmic Visual Acuity Chart (GB11533-2011, China) was used to measure UDVA at 5m. The Standard Medium and Near Visual Acuity Chart (WH09, Wehen Vision Technology Co., LTD, Guangzhou, China) was employed to assess UIVA at 80cm and UNVA at 40cm. Efficacy index (EI)= postoperative UDVA/ preoperative CDVA. Loss and gain in lines of CDVA as well as safety index (defined as mean postoperative CDVA versus mean preoperative CDVA) were evaluated. Safety index (SI)= postoperative CDVA/ preoperative CDVA. Line chart for spherical equivalent refraction of all eyes at follow-ups was plotted. The refractive deviation from target for distance correction was evaluated in spherical equivalent and astigmatism. Contrast sensitivity Contrast sensitivity was measured with an FVA6500 (Vision Science Research Corporation, San Ramon, CA) at best-corrected distance vision and 85 cd/m 2 , 5 spatial frequencies were measured at 1.5 c/d, 3.0 c/d, 6.0 c/d, 12.0 c/d and 18.0 c/d, and the common logarithms were taken and analyzed. Defocus curves Subjective refraction was performed to determine the maximum plus spherical and cylindrical refraction, that maintained optimum distance acuity. Both binocular and monocular defocus curves were measured on the basis of CDVA (eliminating the effect of binocular anisometropia) [19-21] . Before testing, the "0" scale on the X-axis was set to CDVA, the abscissa was the diopter of the attached lenses in front of the eyes, and the ordinate was logMAR visual acuity. Defocus curves were assessed by applying lens blur ranging from +2.0 D to -4.0 D in 0.5 D increments under photopic conditions (100 lux). Distance ETDRS charts were utilized, with the letters randomized for each presentation and magnification effects considered to minimize memory bias, ensuring that every vision result was recorded. For each acuity measurement, when approaching their threshold acuity patients were prompted once with the phrase “Can you read any more letters on the line below?” Subjective questionnaires and primary complaints This research adopts the NEI VFQ-25 and the NAVQ two questionnaires to survey patients subjective feeling. The NEI VFQ-25 is a multidimensional questionnaire designed to assess the impact of eye conditions and visual problems on general quality of life using 25 items across 12 subscales [22] . The questionnaire contained a General Health section and 11 subscales, with six question types (global rating of health, difficulty, frequency, severity, agreement and numeric). For the question of difficulty level, ‘stopped doing this for other reasons or not interested in doing this’ are treated as missing data. Options were converted to a 0-100 score, the General Health component was not scored, and the total score was calculated by means of the other 11 subscales, with higher scores indicating better patient quality of life. This scale encompasses various aspects of quality of life related to vision, including general health status, eye discomfort, distance activities, near activities, social functioning, mental health, and the degree of dependence on others. NAVQ is a specific questionnaire for presbyopia, designed to measure the degree of difficulty with near vision and the satisfaction with methods used for presbyopia correction [23, 24] . It includes ten questions related to near vision tasks, with response options ranging from (no longer perform this task for non-visual reasons, no difficulty, a little difficulty, difficulty, to very difficult, scored from 0 to 3 points). Additionally, there is one question regarding overall satisfaction with near vision, with options of (very satisfied, somewhat satisfied, basically satisfied, neutral, dissatisfied, scored from 0 to 4 points). Responses labeled as "no longer perform this task for non-visual reasons" are treated as missing data. Unlike the NEI VFQ-25, a higher NAVQ score indicates poorer near vision performance and lower satisfaction. In addition to this scale, the overall satisfaction of patients is documented, along with any discomfort affecting daily life reported during a six-month follow-up, such as blurred vision, double vision, glare, halos, or dry eyes. Statistical Analysis The data were analyzed using SPSS software (version 25.0, IBM Corp.NY,USA). Shapiro-Wilk test was used to analyze the normality of the data. Normally distributed data that meet the assumption of homogeneity of variance are expressed as mean ± standard deviation. Comparisons at different time points are conducted using repeated measures ANOVA, while comparisons between the dominant eye, non-dominant eye, and both eyes are conducted using one-way ANOVA. Non-normally distributed data are expressed as median (interquartile range), with data analysis for two time points using the Wilcoxon signed-rank test, and for three or more time points using the Friedman test. while comparisons between the dominant eye, non-dominant eye, and both eyes are conducted using the Kruskal-Wallis H test. The comparison of rates is performed using the χ² test. A two-tailed test is used, and a p-value less than 0.05 is considered statistically significant. Results A total of 22 patients, with an average age of 47.05±3.37 years (range, 42-55 years), comprising 10 men and 12 women, were included in the study. The preoperative MRSE were -4.62±1.75D. All patients underwent successful correction without any reported adverse events during or after procedure. A complete six-month follow-up was conducted for all 22 patients, with their preoperative data shown in Tab 1 . Table 1 Clinical characteristics of patients. Preoperative Monocular eyes Binocular eyes 44 22 Age(y) 47.05±3.37(42 to 55) Gender ratio(M:F) 0.83(10:12) UDVA(LogMAR) 1.17±0.28(0.00 to 1.60) 0.79±0.32(0.00 to 1.00) UIVA(LogRAD) 0.38±0.17(0.00 to 0.80) 0.35±0.19(0.00 to 0.70) UNVA(LogRAD) 0.46±0.10(0.30 to 0.70) 0.47±0.08(0.30 to 0.60) CDVA(LogMAR) -0.03±0.06（-0.10 to 0.10） Spherical (D) -4.33±1.69(-7.75 to -0.25) - Cylinder (D) -0.96±0.63(-2.75 to 0.00) SE(D) -4.81±1.78(-8.38 to -0.38) MRSE(D) -4.62±1.75(-8.25 to -0.00) Add(D) +1.41±0.29(1.00to 2.25) - Pupil diameter(mm) Photopic pupil 3.60±0.45(2.49 to 4.27) - Mesopic pupil 4.57±0.62(3.40 to 5.88) - Scotopic pupil 5.84±0.52(4.63 to 7.01) - Planned Add(D) +1.95±0.12(1.75 to 2.20) UDVA: uncorrected distance visual acuity; UIVA: uncorrected intermediate visual acuity ; UNVA: uncorrected near visual acuity ; DCNVA: distance corrected near visual acuity ; CDVA: corrected distance visual acuity; SE: spherical equivalent; MRSE: manifest refraction spherical equivalent ;logMAR: Log minimum angle resolution; logRAD: Log reading acuity determination, the reading equivalent of logMAR. Efficacy and safety At 6 months postoperatively, the UDVA for the DE, NE, and binocular was recorded as -0.02±0.06 logMAR, 0.26±0.08 logMAR, and -0.04±0.07 logMAR, respectively. The UIVA for the DE, NE, and binocular was recorded as -0.05±0.06 logRAD, 0.00±0.10 logRAD, and -0.08±0.04 logRAD, respectively. The UNVA for the DE, NE, and binocular was recorded as 0.17±0.13 logRAD, -0.03±0.07 logRAD, and -0.05±0.07 logRAD, respectively. The 90.9% (20/22) patients achieved 0.0 logMAR or better of BUDVA, all patients achieved 0.1 logMAR or better. The 100% (22/22) patients achieved 0.0 logRAD or better of BUIVA. The 95.4% (21/22) patients achieved 0.0 logRAD or better of BUNVA. The 95.4%(21/22) of patients achieved at least 0.1 logMAR of BUDVA and 0.1 logRAD of BUNVA at the same time( Fig 1 ). The improvement in UDVA,UIVA and UNVA were statistically significant (all P<0.05). In the DE, 9% achieved one line of CDVA improvement, 91% did not experience a CDVA decrease, 5% lost one line of CDVA in the NE, and 9% improved one line( Fig 2 and Fig 3 ). The preoperative DCNVA of the distance eye was 0.39 ± 0.16 logRAD, and the postoperative was 0.39 ± 0.15 logRAD, with no statistically significant difference. The preoperative DCNVA of the NE was 0.39 ± 0.17 logRAD, and the postoperative one was 0.27 ± 0.13 logRAD. The binocular DCNVA was 0.31 ± 0.15 logRAD preoperatively and 0.23 ± 0.13 logRAD postoperatively. There was no statistically significant difference in DCNVA before the operation (all P > 0.05), while binocular and DE, NE and DE were significantly different postoperatively ( H =3.406, 2.536; P =0.002, 0.034). The safety index (SI) for the DE was 1.01 ± 0.07 and the effectiveness index (EI) was 0.98 ± 0.11; for the NE eye the SI was 1.01 ± 0.07 and the EI was 0.50 ± 0.09. Accuracy and stability The MRSE of the DE was -4.76 ± 1.80D (range: −7.75 to -0.50 D)preoperatively and -0.18 ± 0.27D(range:0.00 to -0.75 D) postoperatively. The mean SE for DE was -4.91 ± 1.75D(range:-8.13 to-0.38 D) preoperatively and −0.45±0.30 D (range: −1.00 to +0.25 D) postoperatively. For the NE, the MRSE was -4.50 ± 1.68D preoperatively and -1.38 ± 0.35D postoperatively. The SE for DE was -4.71 ± 1.87D(range:-8.38 to-0.50 D) preoperatively and −1.25±0.32 D (range: −1.75 to -0.50D) postoperatively. The target induced astigmatism(TIA) and surgically induced astigmatism(SIA) of the DE was 0.78±0.61D and 0.78±0.61D. The TIA and SIA of the NE was 0.92±0.64D and 0.91±0.58D. The target diopter of the DE was 0.00D,91% achieved ±0.50D and 100% achieved ±1.00D. The target diopter of the NE was -0.89D,45% achieved ±0.50D,91% achieved ±1.00D. The corrected astigmatism was <0.50D in 92% of the DE and <0.50D in 100% of the NE( Fig 2 and Fig 3 ). Contrast sensitivity and Defocus curves Compared in logarithmic scale, the changes in binocular contrast sensitivity from the preoperative values in all test conditions were not significantly different at any frequency (all P >0.05). ( Fig 4 ) . At six months postoperatively, binocular defocus curve exhibited a maximum of -0.10±0.04logMAR at 0.0D, -0.00±0.12logMAR at -1.5D, and 0.20±0.16logMAR at -2.5D, with visual acuity surpassing 0.3logMAR for both eyes within the range of +1.5D to -3.0D. Postoperatively, the binocular and NE defocus curves were flatter than preoperatively in the range of 0.0D to -4.0D ( Fig 5 ). NAVQ, NEI VFQ-25 Questionnaire and Subjective Discomfort The NAVQ scores decreased from 19.36±3.55 preoperative to 4.41±2.50 postoperative, which was statistically significant ( t =-13.976, P <0.001). Similarly, the NEI VFQ-25 scores significantly increased from 74.63(71.70, 79.97)pre-op to91.23(86.33, 93.24)postoperatively ( Z =-4.107, P <0.001), as shown in Tab 2 . Except for ‘Distance Activities’ and ‘Peripheral Vision’ showed no significant improvement following surgery, all other dimensions of the NEI VFQ-25 scale showed significant statistical differences post-surgery compared to pre-surgery (all p <0.05). Only one patient failed to achieve complete spectacle removal(correction was required for driving at night or in dim conditions, spectacle independence was achieved at all other times). Full spectacle independence was successfully achieved in 21 out of 22 patients. The primary discomfort reported by the patients at the postoperative follow-up was mild to moderate dry eye, fluctuating visual acuity, blurred vision and difficulty in focusing binocular vision. In the last follow-up, the vast majority of patients reported that their discomfort had subsided or disappeared, and all patients (22/22, 100%) expressed satisfaction or very satisfaction with the surgery, with satisfaction regarding near vision also reaching 100% (22/22). Table 2 The pre- and post-operative NEI VFQ-25 results in patients VFQ-25 categories pre post Z P General Health 50.00(50.00, 75.00) 75.00 (75.00, 81.25) -3.448 0.001 ** General Vision 60.00(60.00,80.00) 80.00(80.00, 80.00) -4.000 0.000 *** Ocular Pain 75.00(50.00,100.00) 100.00(75.00, 100.00) -3.666 0.001 ** Near Activities 50.00(50.00,75.00) 100.00(75.00, 100.00) -6.654 0.000 *** Distance Activities 75.00(75.00, 100.00) 75.00(75.00, 100.00) -1.843 0.065 Vision Specific: Social Functioning 100.00(75.00, 100.00) 100.00(100.00, 100.00) -3.606 0.000 *** Mental Health 100.00(75.00, 100.00) 100.00(100.00, 100.00) -4.593 0.000 *** Role Difficulties 75.00 (50.00, 75.00) 100.00(75.00, 100.00) -4.465 0.000 *** Dependency 100.00(75.00, 100.00) 100.00(100.00,100.00) -3.900 0.000 *** Driving 75.00(75.00, 100.00) 100.00(75.00, 100.00) -4.943 0.000 *** Color Vision 100.00(75.00, 100.00) 100.00(100.00, 100.00) -2.828 0.005 * Peripheral Vision 100.00(75.00, 100.00) 100.00(75.00,100.00) -1.155 0.248 TOTAL SCORE 74.63(71.70, 79.97) 91.23(86.33, 93.24) -4.107 0.000 *** Activities were modified on the translated questionnaire according to the cultural differences. NEI VFQ-25: National Eye Institute Visual Functioning Questionnaire -25 (version 2000). Grading scores: 100 points-No difficulty at all;75 points-A little difficulty;50 points-Moderate difficulty; 25point-Extreme difficulty; 0 point-Stopped doing this because of your eyesight; the answer treated as missing-Stopped doing this for other reasons or not interested in doing this The ‘General Health’ component does not count towards the total score. P ＜0.05*； P ＜0.01**; P＜0.001*** Discussion This study evaluated the efficacy of the PresbyMAX ®monocular ablation mode in 22 patients with myopia and presbyopia. None of the patients experienced a loss of two or more lines, and only one non-dominant eye showed a one-line reduction in CDVA. Following the surgical procedure, the patient's distance, intermediate, and near vision exhibited a significant improvement compared to pre-operation levels, aligning with recent findings in published research [17, 25] . Binocular vision outcomes have demonstrated stability since the first month post-operation. Unlike the previous central PresbyLASIK [11, 26] technology, the excimer laser micro-monovision multifocal bi-aspheric ablation mode utilizes 7-Dimensional Eye Tracking System to ensure precise alignment of the optical axis, pupil, and corneal apex during surgery, thereby mitigating postoperative issues related to distance vision and contrast sensitivity decline [16] , which was confirmed by the results of this study. In a retrospective study, Chan et al. [18] discovered that 14% of patients necessitated additional treatment following presbyopia correction using this technique. This may be attributed to the surgical design employing a lower ADD and the occurrence of postoperative corneal epithelial remodeling. Furthermore, it has been demonstrated that the mean annual progression of hyperopic drift in eyes treated with corneal multifocal ablation is +0.1D [27 ] . By incorporating various lenses in front of the eye to induce defocus and plotting defocus curves, it is feasible to replicate diverse visual requirements at varying distances. The defocus curve is frequently employed for assessing the efficacy of multifocal or adjustable intraocular lenses [28, 29] , as well as for evaluating the impact of corneal surgery on presbyopia correction [27, 30] . Research has demonstrated a notable decline in the defocus curve of patients in the early stages of presbyopia at intermediate and near distances [31] , with preoperative results aligning with this conclusion. The results of this study revealed that at 6mo post-surgery, there was no statistically significant difference among the monocular and binocular within the range of +2.0D to 0.0D. In the 0.0D to -4D range, the binocular defocus curves exhibited no significant difference from those of the NE and demonstrated a significantly superior performance compared to those of the dominant eye. The binocular and NE curves displayed a flatter profile, a finding that holds clinical significance. This suggests that employing micro-monovision with multifocal non-spherical ablation significantly enhances near to mid-distance vision while exerting minimal influence on the CDVA of binocular eyes. Luger et al. [19, 27] observed that the defocus curve could still reach preoperative levels after more than six years of long-term follow-up, which is similar to the results of this study. It did not exhibit the multi-peak characteristics, here corneal “multifocality” are considered “synonymous wanted effects” sought as a compensation for presbyopia (in a continuous progressive manner), and should not be mixed up with a stepwise multifocality generally termed bifocality, tri-focality used in reading spectacles or IOLs. The changes in the curve, combined with the improvement in DCNVA, indicate an increase in depth of focus for binocular and the NE. In practical applications, the accuracy of defocus curves is influenced by various factors, including patient tolerance. If a patient experiences fatigue, the accuracy of the defocus curve decreases significantly. Furthermore, variables such as age, accommodative function, pupil diameter, contrast sensitivity, and higher-order aberrations can also impact the outcomes [32] . Subsequent research could integrate additional indicators into the defocus curve or optimize the examination process to improve precision. The results of the subjective scales(NAVQ and NEI VFQ-25) showed significant improvement after surgery. Furthermore, the assessment using the NEI VFQ-25 scale revealed that the surgery had a multidimensional positive impact on the patients. The improvement in the total score and “General Vision” score clearly reflects an increase in patient satisfaction regarding their overall visual function. Additionally, the rise in scores for dimensions such as “Ocular Pain”, “Near Activities”, “Social Functioning”, “Mental Health”, and “Dependency” on others indicates that the surgery not only achieved excellent results in vision quality but also significantly improved the patients' quality of life. Postoperative improvements in vision have effectively enhanced the perception of overall health, alleviated eye discomfort, and reduced negative emotions such as anxiety and depression. Moreover, the enhancement of vision has led to better social participation and performance among patients, decreased dependence on others, and increased self-efficacy, further promoting patients' physical and mental well-being. Postoperatively, the most commonly reported visual discomforts were blurred vision, decreased night vision, glare, and dry eye symptoms, consistent with findings from previous studies [17, 19] . they still reported satisfaction after using artificial tears or wearing corrective lenses. These symptoms will gradually diminish or disappear within three to six months, in conjunction with restoration of visual balance in both eyes, restoration of ocular surface health, and appropriate use of perioperative medications. Furthermore, only one patient in this study required the use of corrective lenses for distance vision in the evening or while driving at night following surgery. This may be attributed to the patient's larger scotopic pupil diameter and the higher ADD employed in the procedure. The remaining patients were able to achieve spectacle independence. The daily visual performance of presbyopic patients is significantly correlated with factors such as gender, occupation and reading habits, e.g. patients with longer arms can somewhat reduce the need for near vision aids. In recent years, there has been an increasing frequency of presbyopic patients participating in activities at both near and intermediate distances [33] , further heightening the demand for good intermediate and near vision. In this study, a high proportion of patients were engaged in occupations such as accounting and teaching, which require extensive computer use and close-up work. The aforementioned findings indicate that it is crucial to strictly adhere to surgical indications and fully consider patient needs. During the surgical design phase, personalized ADD should be incorporated for the patient. In preoperative communication, it is important to emphasize to the patient the potential visual discomforts that may occur in the early postoperative period, such as fluctuations in vision and blurred vision, over the first 3 to 6 months. In certain specific situations, patients may still require vision correction. This approach can help set reasonable expectations for the surgery, effectively alleviating patient anxiety and enhancing overall satisfaction. The limitations of this study include a relatively small sample size, which restricts the scope of the research. Future studies should include a larger number of patients, particularly those with other refractive errors combined with presbyopia, as well as patients with isolated presbyopia. Additionally, this study only measured the defocus curves after correction, failing to reflect the real-world performance of patients without correction. Subsequent research will combine measurements of uncorrected defocus curves, accommodative function, aberrations, Strehl ratio, and stereopsis to provide a more comprehensive assessment of visual quality. In conclusion, the excimer laser micro-monovision multifocal bi-spherical ablation mode is a secure and efficacious approach for presbyopia correction. It has demonstrated significant enhancements in both distance and near vision, leading to high levels of patient satisfaction. While some patients may initially experience symptoms such as blurred vision, reduced night vision, glare, and dry eyes following the procedure, these discomforts typically diminish or resolve over time. Declarations Ethics approval and consent to participate This study is a consecutive case series study conducted at a single center and follows the guidelines set forth in the Declaration of Helsinki. It has been approved by the Ethics Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine (HEC-KS-2020003KY), registered with the Chinese Clinical Trial Registry under the number "ChiCTR2300074821," and written informed consent was obtained from all study participants. Consent for publication Not Applicable Availability of data and materials Data is provided within the manuscript or supplementary information files Competing interests The authors declare no competing interests. Funding Shandong Province Medical and Health Science and Technology Development Program (No. 202207020806)，awarded to Dr. Peng Ji. Authors' contributions P.J. conducted the conception and design of the study and approved the final version of the manuscript; L.L. performed the examinations during each follow-up, drafted the work, analyzed the data, and revised the manuscript. X.W. performed the examinations during each follow-up and analyzed the data; X.W., H.F., and H.B. conducted the conception, design of the study and interpretation of data. Acknowledgements We thank the medical staff of the Department of Refractive Surgery, Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine for their support of this research. References Wolffsohn JS, Davies LN, Presbyopia. Effectiveness of correction strategies. Prog Retin Eye Res. 2019;68:124–43. 10.1016/j.preteyeres.2018.09.004 . Wolffsohn JS, Naroo SA, Bullimore MA, Craig JP, Davies LN, Markoulli M, et al. BCLA CLEAR Presbyopia: Definitions. Cont Lens Anterior Eye. 2024;102155. 10.1016/j.clae.2024.102155 . Markoulli M, Fricke TR, Arvind A, Frick KD, Hart KM, Joshi MR, et al. BCLA CLEAR Presbyopia: Epidemiology and impact. Cont Lens Anterior Eye. 2024;102157. 10.1016/j.clae.2024.102157 . Fricke TR, Tahhan N, Resnikoff S, Papas E, Burnett A, Ho SM, et al. Global Prevalence of Presbyopia and Vision Impairment from Uncorrected Presbyopia: Systematic Review, Meta-analysis, and Modelling. Ophthalmology. 2018;125(10):1492–9. 10.1016/j.ophtha.2018.04.013 . Trends in prevalence of. blindness and distance and near vision impairment over 30 years: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021;9(2):e130–130143. 10.1016/S2214-109X(20)30425-3 . Frick KD, Joy SM, Wilson DA, Naidoo KS, Holden BA. The Global Burden of Potential Productivity Loss from Uncorrected Presbyopia. Ophthalmology. 2015;122(8):1706–10. 10.1016/j.ophtha.2015.04.014 . Chan VF, MacKenzie GE, Kassalow J, Gudwin E, Congdon N. Impact of Presbyopia and Its Correction in Low- and Middle-Income Countries. Asia Pac J Ophthalmol (Phila). 2018;7(6):370–4. 10.22608/APO.2018449 . Donaldson KE. The Economic Impact of Presbyopia. J Refract Surg. 2021;37(S1):S17–1719. 10.3928/1081597X-20210408-03 . Wolffsohn JS, Davies LN, Sheppard AL. New insights in presbyopia: impact of correction strategies. BMJ Open Ophthalmol. 2023;8(1):e001122. 10.1136/bmjophth-2022-001122 . Agarwal S, Thornell E. Early Outcomes of Two Treatment Modes of PresbyLASIK: Monocular vs. Micro-Monovision. Clin Ophthalmol. 2022;16:3597–606. 10.2147/OPTH.S384553 . Alió JL, Chaubard JJ, Caliz A, Sala E, Patel S. Correction of presbyopia by technovision central multifocal LASIK (presbyLASIK). J Refract Surg. 2006;22(5):453–60. 10.3928/1081-597X-20060501-06 . Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009;25(6):516–23. 10.3928/1081597X-20090512-05 . Vargas-Fragoso V, Alió JL. Corneal compensation of presbyopia: PresbyLASIK: an updated review. Eye Vis (Lond). 2017;4:11. 10.1186/s40662-017-0075-9 . Uthoff D, Pölzl M, Hepper D, Holland D. A new method of cornea modulation with excimer laser for simultaneous correction of presbyopia and ametropia. Graefes Arch Clin Exp Ophthalmol. 2012;250(11):1649–61. 10.1007/s00417-012-1948-1 . Luger MH, Ewering T, Arba-Mosquera S. One-year experience in presbyopia correction with biaspheric multifocal central presbyopia laser in situ keratomileusis. Cornea. 2013;32(5):644–52. 10.1097/ICO.0b013e31825f02f5 . Liu F, Zhang T, Liu Q. One year results of presbyLASIK using hybrid bi-aspheric micro-monovision ablation profile in correction of presbyopia and myopic astigmatism. Int J Ophthalmol. 2020;13(2):271–7. 10.18240/ijo.2020.02.11 . Fu D, Zhao J, Zeng L, Zhou X. One Year Outcome and Satisfaction of Presbyopia Correction Using the PresbyMAX® Monocular Ablation Profile. Front Med (Lausanne). 2020;7:589275. 10.3389/fmed.2020.589275 . Chan TC, Kwok PS, Jhanji V, Woo VC, Ng AL. Presbyopic Correction Using Monocular Bi-aspheric Ablation Profile (PresbyMAX) in Hyperopic Eyes: 1-Year Outcomes. J Refract Surg. 2017;33(1):37–43. 10.3928/1081597X-20161006-03 . Luger MH, McAlinden C, Buckhurst PJ, Wolffsohn JS, Verma S, Arba Mosquera S. Presbyopic LASIK using hybrid bi-aspheric micro-monovision ablation profile for presbyopic corneal treatments. Am J Ophthalmol. 2015;160(3):493–505. 10.1016/j.ajo.2015.05.021 . Wolffsohn JS, Jinabhai AN, Kingsnorth A, Sheppard AL, Naroo SA, Shah S, et al. Exploring the optimum step size for defocus curves. J Cataract Refract Surg. 2013;39(6):873–80. 10.1016/j.jcrs.2013.01.031 . Kohnen T, Lemp-Hull J, Suryakumar R. Defocus curves: focusing on factors influencing assessment. J Cataract Refract Surg. 2022;48(8):961–8. 10.1097/j.jcrs.0000000000000906 . Mozdbar S, Alber J, Aryal S, Johnson L, Moroz A, Rashik M, et al. Cognitive dysfunction and the 25-item National Eye Institute Visual Function Questionnaire. Alzheimers Dement (Amst). 2022;14(1):e12378. 10.1002/dad2.12378 . Wolffsohn JS, Berkow D, Chan KY, Chaurasiya SK, Fadel D, Haddad M, et al. BCLA CLEAR Presbyopia: Evaluation and diagnosis. Cont Lens Anterior Eye. 2024;102156. 10.1016/j.clae.2024.102156 . Sharma G, Chiva-Razavi S, Viriato D, Naujoks C, Patalano F, Bentley S, et al. Patient-reported outcome measures in presbyopia: a literature review. BMJ Open Ophthalmol. 2020;5(1):e000453. 10.1136/bmjophth-2020-000453 . Ryu S, Jun I, Kang D, Arba-Mosquera S, Kim H, Jean SK, et al. Presbyopia correction using the monocular bi-aspheric ablation profile in myopic eyes. J Cataract Refract Surg. 2023;49(1):69–75. 10.1097/j.jcrs.0000000000001042 . Alió JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009;20(4):264–71. 10.1097/icu.0b013e32832a7ded . Luger M, McAlinden C, Buckhurst PJ, Wolffsohn JS, Verma S, Arba-Mosquera S. Long-term Outcomes After LASIK Using a Hybrid Bi-aspheric Micro-monovision Ablation Profile for Presbyopia Correction. J Refract Surg. 2020;36(2):89–96. 10.3928/1081597X-20200102-01 . Sugawara K, Ito R, Horiguchi H, Mizobuchi K, Katagiri S, Gunji H, et al. Surgical outcome comparisons of multifocal IOLs of Lentis Comfort LS-313 MF15 and Tecnis Eyhance DIB00V. Int J Ophthalmol. 2023;16(12):2004–10. 10.18240/ijo.2023.12.12 . Hui N, Chu MF, Li Y, Wang CY, Yu L, Ma B. Comparative analysis of visual quality between unilateral implantation of a trifocal intraocular lens and a rotationally asymmetric refractive multifocal intraocular lens. Int J Ophthalmol. 2022;15(9):1460–7. 10.18240/ijo.2022.09.08 . Zhang J, Shao J, Cao X, Zhang Y, Zheng L. Defocus Curve and Satisfaction of Patients with Presbyopia After LASIK Using the Differential Modulation of Binocular Longitudinal Spherical Aberration. Clin Ophthalmol. 2023;17:3531–42. 10.2147/OPTH.S437324 . Shafer BM, Puls-Boever K, Berdahl JP, Thompson V, Ibach MJ, Zimprich LL, et al. Defocus Curve of Emerging Presbyopic Patients. Clin Ophthalmol. 2023;17:843–7. 10.2147/OPTH.S400194 . Arba Mosquera S. Visual acuity and blur: An extended depth-of-focus model. Eur J Ophthalmol. 2022;11206721221123883. 10.1177/11206721221123883 . Ribeiro F, Ferreira TB, Silva D, Matos AC, Gaspar S, Piñero DP. Analysis of Daily Visual Habits in a Presbyopic Population. J Ophthalmol. 2023;2023:6440954. 10.1155/2023/6440954 . Additional Declarations No competing interests reported. Supplementary Files BMCdata.xlsx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5995145","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":440303787,"identity":"3f02309f-0294-4ed2-a086-e8c8de4b7c08","order_by":0,"name":"Li Li","email":"","orcid":"","institution":"Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Li","middleName":"","lastName":"Li","suffix":""},{"id":440303788,"identity":"25bdb316-a596-4798-9501-76cf72bc693f","order_by":1,"name":"Xiaofan Wang","email":"","orcid":"","institution":"Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Xiaofan","middleName":"","lastName":"Wang","suffix":""},{"id":440303789,"identity":"d3bdb824-a07e-480d-a98b-9198ca9a0bd9","order_by":2,"name":"Hongsheng Bi","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Hongsheng","middleName":"","lastName":"Bi","suffix":""},{"id":440303792,"identity":"da2b29f2-d06f-441b-8d28-295e6edc80c2","order_by":3,"name":"Xingrong Wang","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Xingrong","middleName":"","lastName":"Wang","suffix":""},{"id":440303795,"identity":"40f31ed5-fbf5-4af2-9ff3-e83cda732322","order_by":4,"name":"Hua Fan","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Hua","middleName":"","lastName":"Fan","suffix":""},{"id":440303799,"identity":"f6db3da8-2439-4a49-8bc1-5cb9ecdad449","order_by":5,"name":"Peng Ji","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAtElEQVRIiWNgGAWjYBACxmbmgw8S/9jw8LM3EK2FLdngY0OajGTPAaLt4VETnNlw2MbghgORGpjbediYeXec52G4wcD44WMOUQ7jPfaY98xtHsbZDcySM7cRpYUv3ZiH7TYPs8wBoHXEaeExk+ZhO8fDJpFAghbJmW0HeHhI0AIM5A9nknkkeA42E+cXw/7DBx8kVNjZ2x9vPvjhI1FaGhAWNuBUhQLkiVM2CkbBKBgFIxoAAG0XNCYGHhHZAAAAAElFTkSuQmCC","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":true,"prefix":"","firstName":"Peng","middleName":"","lastName":"Ji","suffix":""}],"badges":[],"createdAt":"2025-02-10 03:08:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5995145/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5995145/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":80578922,"identity":"09bdce04-bb2e-4db0-a80d-7386d35fd240","added_by":"auto","created_at":"2025-04-14 23:06:30","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":376613,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eUncorrected distance, intermediate, near visual acuity results after PresbyMAX\u003c/strong\u003e\u003csup\u003e\u003cstrong\u003e®\u003c/strong\u003e\u003c/sup\u003e\u003cstrong\u003e monocular correction presbyopia with myopia.\u003c/strong\u003e The BUDVA, BUIVA, and BUNVA for all patients remained stable from 1mo postoperatively. 1a-UDVA, 1b-UIVA, 1c-UNVA. d, w, and mo represent days, weeks, and months, respectively.\u003c/p\u003e","description":"","filename":"image1.png","url":"https://assets-eu.researchsquare.com/files/rs-5995145/v1/2eba1733c1d3118e093eff60.png"},{"id":80581701,"identity":"ca4a9016-347b-4d84-9c53-806635d387b7","added_by":"auto","created_at":"2025-04-14 23:22:30","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1390200,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eMono-focal regular FS-LASIK was used to correct the refractive effect of the dominant eye. \u003c/strong\u003eA-uncorrected distance visual acuity; B-uncorrected distance visual acuity vs. corrected distance visual acuity; C-change in corrected distance visual acuity; D-spherical equivalent refraction attempted; E-spherical equivalent refraction accuracy; F-spherical equivalent refraction stability; G- refractive astigmatism; H-target induced astigmatism vs surgically induced astigmatism; I-refractive astigmatism angle of error.\u003c/p\u003e","description":"","filename":"image2.png","url":"https://assets-eu.researchsquare.com/files/rs-5995145/v1/7143da647c0a15db91ac53fb.png"},{"id":80582447,"identity":"4b8b8dae-f64d-4404-b767-39560ef74059","added_by":"auto","created_at":"2025-04-14 23:30:30","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":1449213,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eMultifocal bi-aspheric ablation(PresbyMAX\u003c/strong\u003e\u003csup\u003e\u003cstrong\u003e®\u003c/strong\u003e\u003c/sup\u003e\u003cstrong\u003emonocular) was used to correct the refractive effect of the non-dominant eye. \u003c/strong\u003eA-uncorrected distance visual acuity; B-uncorrected distance visual acuity vs. corrected distance visual acuity; C-change in corrected distance visual acuity; D-spherical equivalent refraction attempted; E-spherical equivalent refraction accuracy; F-spherical equivalent refraction stability; G- refractive astigmatism; H-target induced astigmatism vs surgically induced astigmatism; I-refractive astigmatism angle of error.\u003c/p\u003e","description":"","filename":"image3.png","url":"https://assets-eu.researchsquare.com/files/rs-5995145/v1/88406f2fdef03701e1873e0b.png"},{"id":80578931,"identity":"28acf411-b07d-426c-b291-bfb52108f0fa","added_by":"auto","created_at":"2025-04-14 23:06:30","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":286205,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe preoperative and postoperative contrast sensitivity of PresbyMAX® monocular protocol correction presbyopia with myopia. \u003c/strong\u003eContrast Sensitivity ：CS. a-Preoperative CS of both eyes, b-Postoperative CS of both eyes, c- CS of the dominant eye before and after surgery, d-CS of non-dominant eyes before and after surgery\u003c/p\u003e","description":"","filename":"image4.png","url":"https://assets-eu.researchsquare.com/files/rs-5995145/v1/ce9ce754c90b6b050bfaf0f8.png"},{"id":80581700,"identity":"621821f9-0e08-4695-ae73-9296f112ccd7","added_by":"auto","created_at":"2025-04-14 23:22:30","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":475290,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe preoperative and postoperative defocus curve of PresbyMAX® monocular protocol correction presbyopia with myopia .\u003c/strong\u003e a-preoperative, b-postoperative. The results indicate that there were no significant differences in binocular and monocular defocus curves preoperative (all \u003cem\u003eP\u003c/em\u003e＞0.05). Within the range of +2D to 0D, there was no statistically significant difference between binocular and monocular defocus curve; however, a statistically significant difference was observed between the binocular and dominant eye (all \u003cem\u003eP\u003c/em\u003e\u0026lt; 0.05) within the range of 0.0D to -4.0D, with no such difference noted between the binocular and the non-dominant eye\u003cstrong\u003e.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"image5.png","url":"https://assets-eu.researchsquare.com/files/rs-5995145/v1/910c8c086c2febc7f7672186.png"},{"id":95082916,"identity":"32a0ef2d-d4ca-44f4-9b2a-a5d3d3703ccc","added_by":"auto","created_at":"2025-11-04 06:38:45","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":4790762,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5995145/v1/6d917b1e-5137-45a2-bbe1-33e935a17c35.pdf"},{"id":80578926,"identity":"4160c461-df69-4490-8133-ff44ecd04887","added_by":"auto","created_at":"2025-04-14 23:06:30","extension":"xlsx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":121877,"visible":true,"origin":"","legend":"","description":"","filename":"BMCdata.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-5995145/v1/78d4a31b3b1e04c890222893.xlsx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Postoperative assessment of monocular multifocal bi-aspheric ablation pattern for correcting myopia with presbyopia","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePresbyopia is defined as occurring when the physiologically normal age-related reduction in the eye\u0026lsquo;s focusing range reaches a point that, when optimally corrected for distance vision, the clarity of vision at near is insufficient to satisfy an individual\u0026rsquo;s requirements \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e. The global prevalence of presbyopia was 24.9% in 2015, and it is expected that 24.1%(2.1\u0026nbsp;billion) of the population will suffer from presbyopia in 2030\u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. In some developing countries, more than 50% of the population lack sufficient near correction, while in developed countries, up to 34% face the same problem\u003csup\u003e[\u003cspan additionalcitationids=\"CR5 CR6\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e. Uncorrected presbyopia significantly diminishes quality of life, the treatment of presbyopia gradually become a huge challenge for the eye doctor\u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e. Currently, various methods exist to address presbyopia, yet there is no recognized best scheme\u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eCompared with intraocular surgery, corneal refractive surgery because of its small invasive, more popular with the patients and eye doctor. Frequently employed techniques, including monocular vision, multifocal ablation, Q-value adjustment, and aberration optimization, are typically integrated into corneal refractive surgery. Cornea has been found can partly compensate the loss of accommodation due to the crystalline lens stiffen with aging by special cornea surface ablation, such as creation of a multifocal optical profile. The treatment method for presbyopia that employs LASIK technology to create a multifocal corneal shape is known as \"PresbyLASIK.\". This method is mainly categorized into Central PresbyLASIK (central near vision)\u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e and Peripheral PresbyLASIK (peripheral near vision)\u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e. Central PresbyLASIK is more aligned with the normal physiological state of the human eye, it involves less corneal ablation compared to peripheral PresbyLASIK. It introduces negative spherical aberration while minimizing other higher-order aberrations, making it more broadly applicable in clinical practice\u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e. PresbyMAX (Schwind Eye-Tech-Solutions GmbH and Co., Kleinostheim, Germany) is a central presbyLASIK technology that combines the treatment of presbyopia and ametropia with the bi-spherical ablation profile using the Schwind AMARIS excimer laser system, which works by creating a central convex corneal shape and the controlled induction of negative spherical aberration combined with the induction of a low amount of myopia, thereby decreasing patients' reliance on spectacles\u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e. The system has experienced several mode updates. In the present study, the PresbyMAX\u0026reg; monocular mode was employed for bi-aspherical optimized multi-focus ablation, targeting a diopter of -0.89D for non-dominant eyes. Additionally, conventional single-focus FS-LASIK ablation was utilized, with a target diopter of 0.00D for dominant eyes. Previous studies have reported on the visual acuity and visual quality of patients after this surgical\u003csup\u003e[\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e, but the quantity of published research is limited. Since presbyopia is primarily a functional issue, greater emphasis should be placed on subjective experiences and daily performance. This study aims to evaluate the efficacy following treatment with the excimer laser micro-monovision multifocal non-spherical ablation pattern through assessments of visual acuity, contrast sensitivity, defocus curves, and questionnaires.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cp\u003eEthical Approval\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis study is a\u0026nbsp;consecutive case series\u0026nbsp;conducted at a single center and follows the guidelines set forth in the Declaration of Helsinki. It has been approved by the Ethics Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine (HEC-KS-2020003KY), registered with the Chinese Clinical Trial Registry under the number \"ChiCTR2300074821,\" and written informed consent was obtained from all study participants.\u003c/p\u003e\n\u003cp\u003ePatients\u003c/p\u003e\n\u003cp\u003ePatients meeting the following criteria were included in the study: aged 40-55 years, diagnosed with bilateral presbyopia and possessing healthy crystalline lenses. Spherical power : -0.50 to -8.00D; cylinder ≤ 4.0D; UNVA ≤20/50, with corrected near visual acuity (CNVA) improved by at least 1 line; CDVA ≥20/25. Photopic pupil between 2.5 and 3.5 mm, and Scotopic pupil diameter＞4.5 mm. Corneal curvature between 40 and 48D. Corneal spherical aberration(6mm)\u0026gt; 0μm, whole eye \u0026gt; -0.2μm; corneal higher-order aberration (6mm) mean square \u0026lt; 0.5μm. The possibility of wearing glasses postoperatively is acceptable.\u003c/p\u003e\n\u003cp\u003eExclusion criteria are as follows: systemic illness, previous ocular surgery, abnormal corneal topography or biomechanical, clinically relevant lens opacity, any signs of binocular vision anomalies at distance and near and a pupil offset of 0.7 mm or more, professionals engaged in tasks that require precision and fine motor skills, intolerance to the preoperative anisometropic test at least 1.0D.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePreoperative Assessments\u003c/p\u003e\n\u003cp\u003eIn conjunction with the standard preoperative assessment, additional evaluations were conducted, including an assessment of visual function, contrast sensitivity, defocus curve, monocular vision test, and the questionnaires, utilizing the National Eye Institute 25-item Visual Function Questionnaire(NEI VFQ-25, 2000 version) and the Near the Activity Visual Questionnaire(NAVQ). The dominant eye was determined through a \"hole test,\" with repeated checks until two consecutive results are identical. The monovision test regulates the binocular refractive difference to be between 1.0D and 1.5D, guaranteeing that the dominant eye receives complete visual correction. If the dominant eye's UDVA ≥20/25, only the non-dominant eye will undergo treatment. The Sirius tomograph and corneal topographer (Schwind eye-tech-solutions, software version 2.6.3, Kleinostheim, Germany) was used to capture corneal data for surgery design and to obtain pupil data at photopic, mesopic and scotopic conditions. To ensure optimal corneal data and patient alignment, only high-quality acquisitions of corneal tomography were utilized for surgical design. These acquisitions must meet specific criteria, including the successful passed of the static cyclotorsion component (SCC) check and the attainment of the 14th Placido circle, which provides approximately 7 mm of coverage as a minimum requirement.\u003c/p\u003e\n\u003cp\u003eSurgical Technique\u003c/p\u003e\n\u003cp\u003eAll surgeries were performed by the same operator (JP) between January 2023 to March 2024. Preoperative routine disinfection and local anesthesia. A VisuMax femtosecond laser (Carl Zeiss Meditec AG, Jena, Germany) was utilized to create a corneal flap with a thickness of 100μm and a diameter of 8.10mm, with a 60° edge cutting angle and the hinge located at 90°. Following the flap creation, the Schwind AMARIS 1050RS excimer laser platform (Schwind eye-tech-solutions GmbH, Kleinostheim, Germany) was employed for stromal ablation.\u0026nbsp;The dominant eye underwent ablation using the Aberration-Free mode receives complete visual correction. The non-dominant eye received treatment with the monocular-presbyopia mode from the PresbyMAX module, which automatically adjusts the central near vision area (0 to 3mm) based on the original refractive error correction. This creates a prominent multifocal aspheric profile within the central 3mm zone, influenced by the near addition amount—higher additions result in more forward protrusion at the center. Additionally, the transition area between near and distance vision was optimized asphericly to ensure a smooth transition between the two. Both the flap and the ablation profile were centered on the corneal vertex determined at the Sirius corneal topography instrument (Schwind eye-tech-solutions GmbH, Kleinostheim, Germany), which closely approximates the visual axis. The planned addition for the non-dominant eye is between +1.75D and +2.50D. The target diopter of the dominant eye was 0.00D, and that of the non-dominant eye was -0.89 D. The optimal transition zone and ablation amount were calculated according to age, preoperative diopter and optical treatment zone.\u003c/p\u003e\n\u003cp\u003eOutcome Measures\u003c/p\u003e\n\u003cp\u003eThe main outcome measures were accuracy, efficacy, safety, and stability.\u003c/p\u003e\n\u003cp\u003ePatients were reviewed at 1day, 1week, and 1month, 3month and 6month after surgery, record monocular and binocular UDVA, CDVA, UIVA, and UNVA. The Standard Logarithmic Visual Acuity Chart (GB11533-2011, China) was used to measure UDVA at 5m. The Standard Medium and Near Visual Acuity Chart (WH09, Wehen Vision Technology Co., LTD, Guangzhou, China) was employed to assess UIVA at 80cm and UNVA at 40cm. Efficacy index (EI)= postoperative UDVA/ preoperative CDVA. Loss and gain in lines of CDVA as well as safety index (defined as mean postoperative CDVA versus mean preoperative CDVA) were evaluated. Safety index (SI)= postoperative CDVA/ preoperative CDVA. Line chart for spherical equivalent refraction of all eyes at follow-ups was plotted. The refractive deviation from target for distance correction was evaluated in spherical equivalent and astigmatism.\u003c/p\u003e\n\u003cp\u003eContrast sensitivity\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eContrast sensitivity was measured with an FVA6500 (Vision Science Research Corporation, San Ramon, CA) at best-corrected distance vision and 85 cd/m\u003csup\u003e2\u003c/sup\u003e, 5 spatial frequencies were measured at 1.5 c/d, 3.0 c/d, 6.0 c/d, 12.0 c/d and 18.0 c/d, and the common logarithms were taken and analyzed.\u003c/p\u003e\n\u003cp\u003eDefocus curves\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSubjective refraction was performed to determine the maximum plus spherical and cylindrical refraction, that maintained optimum distance acuity. Both binocular and monocular defocus curves were measured on the basis of CDVA (eliminating the effect of binocular anisometropia)\u003csup\u003e[19-21]\u003c/sup\u003e. Before testing, the \"0\" scale on the X-axis was set to CDVA, the abscissa was the diopter of the attached lenses in front of the eyes, and the ordinate was logMAR visual acuity. Defocus curves were assessed by applying lens blur ranging from +2.0 D to -4.0 D in 0.5 D increments under photopic conditions (100 lux). Distance ETDRS charts were utilized, with the letters randomized for each presentation and magnification effects considered to minimize memory bias, ensuring that every vision result was recorded. For each acuity measurement, when approaching their threshold acuity patients were prompted once with the phrase “Can you read any more letters on the line below?”\u003c/p\u003e\n\u003cp\u003eSubjective questionnaires and primary complaints\u003c/p\u003e\n\u003cp\u003eThis research adopts the NEI VFQ-25 and the NAVQ two questionnaires to survey patients subjective feeling. The NEI VFQ-25 is a multidimensional questionnaire designed to assess the impact of eye conditions and visual problems on general quality of life using 25 items across 12 subscales\u003csup\u003e[22]\u003c/sup\u003e. The questionnaire contained a General Health section and 11 subscales, with six question types (global rating of health, difficulty, frequency, severity, agreement and numeric). For the question of difficulty level, ‘stopped doing this for other reasons or not interested in doing this’ are treated as missing data. Options were converted to a 0-100 score, the General Health component was not scored, and the total score was calculated by means of the other 11 subscales, with higher scores indicating better patient quality of life. This scale encompasses various aspects of quality of life related to vision, including general health status, eye discomfort, distance activities, near activities, social functioning, mental health, and the degree of dependence on others.\u003c/p\u003e\n\u003cp\u003eNAVQ is a specific questionnaire for presbyopia, designed to measure the degree of difficulty with near vision and the satisfaction with methods used for presbyopia correction\u003csup\u003e[23, 24]\u003c/sup\u003e. It includes ten questions related to near vision tasks, with response options ranging from (no longer perform this task for non-visual reasons, no difficulty, a little difficulty, difficulty, to very difficult, scored from 0 to 3 points). Additionally, there is one question regarding overall satisfaction with near vision, with options of (very satisfied, somewhat satisfied, basically satisfied, neutral, dissatisfied, scored from 0 to 4 points). Responses labeled as \"no longer perform this task for non-visual reasons\" are\u0026nbsp;treated as missing data. Unlike the NEI VFQ-25, a higher NAVQ score indicates poorer near vision performance and lower satisfaction. In addition to this scale, the overall satisfaction of patients is documented, along with any discomfort affecting daily life reported during a six-month follow-up, such as blurred vision, double vision, glare, halos, or dry eyes.\u003c/p\u003e\n\u003cp\u003eStatistical Analysis\u003c/p\u003e\n\u003cp\u003eThe data were analyzed using SPSS software (version 25.0, IBM Corp.NY,USA). Shapiro-Wilk test was used to analyze the normality of the data. Normally distributed data that meet the assumption of homogeneity of variance are expressed as mean ± standard deviation. Comparisons at different time points are conducted using repeated measures ANOVA, while comparisons between the dominant eye, non-dominant eye, and both eyes are conducted using one-way ANOVA. Non-normally distributed data are expressed as median (interquartile range), with data analysis for two time points using the Wilcoxon signed-rank test, and for three or more time points using the Friedman test. while comparisons between the dominant eye, non-dominant eye, and both eyes are conducted using the Kruskal-Wallis H test. The comparison of rates is performed using the χ² test. A two-tailed test is used, and a p-value less than 0.05 is considered statistically significant.\u0026nbsp;\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 22 patients, with an average age of 47.05\u0026plusmn;3.37 years (range, 42-55 years), comprising 10 men and 12 women, were included in the study. The preoperative MRSE were -4.62\u0026plusmn;1.75D. All patients underwent successful correction without any reported adverse events during or after procedure. A complete six-month follow-up was conducted for all 22 patients, with their preoperative data shown in \u003cstrong\u003eTab 1\u003c/strong\u003e.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;Clinical characteristics of patients.\u003c/strong\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"595\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003ePreoperative\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003eMonocular eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003eBinocular eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e22\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eAge(y)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 406px;\"\u003e\n \u003cp\u003e47.05\u0026plusmn;3.37(42 to 55)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eGender ratio(M:F)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 406px;\"\u003e\n \u003cp\u003e0.83(10:12)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eUDVA(LogMAR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e1.17\u0026plusmn;0.28(0.00 to 1.60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e0.79\u0026plusmn;0.32(0.00 to 1.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eUIVA(LogRAD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e0.38\u0026plusmn;0.17(0.00 to 0.80)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e0.35\u0026plusmn;0.19(0.00 to 0.70)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eUNVA(LogRAD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e0.46\u0026plusmn;0.10(0.30 to 0.70)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e0.47\u0026plusmn;0.08(0.30 to 0.60)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eCDVA(LogMAR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e-0.03\u0026plusmn;0.06（-0.10 to 0.10）\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eSpherical (D)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e-4.33\u0026plusmn;1.69(-7.75 to -0.25)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eCylinder (D)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e-0.96\u0026plusmn;0.63(-2.75 to 0.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eSE(D)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e-4.81\u0026plusmn;1.78(-8.38 to -0.38)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eMRSE(D)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e-4.62\u0026plusmn;1.75(-8.25 to -0.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eAdd(D)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e+1.41\u0026plusmn;0.29(1.00to 2.25)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003ePupil diameter(mm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003ePhotopic pupil\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e3.60\u0026plusmn;0.45(2.49 to 4.27)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eMesopic pupil\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e4.57\u0026plusmn;0.62(3.40 to 5.88)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003eScotopic pupil\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e5.84\u0026plusmn;0.52(4.63 to 7.01)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 189px;\"\u003e\n \u003cp\u003ePlanned Add(D)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 198px;\"\u003e\n \u003cp\u003e+1.95\u0026plusmn;0.12(1.75 to 2.20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 208px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" style=\"width: 595px;\"\u003e\n \u003cp\u003eUDVA: uncorrected distance visual acuity; UIVA: uncorrected intermediate visual acuity ; UNVA: uncorrected near visual acuity ; DCNVA: distance corrected near visual acuity ; CDVA: corrected distance visual acuity; SE: spherical equivalent; MRSE: manifest refraction spherical equivalent \u0026nbsp;;logMAR: Log minimum angle resolution; logRAD: Log reading acuity determination, the reading equivalent of logMAR.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eEfficacy and safety\u003c/p\u003e\n\u003cp\u003eAt 6 months postoperatively, the UDVA for the DE, NE, and binocular was recorded as -0.02\u0026plusmn;0.06 logMAR, 0.26\u0026plusmn;0.08 logMAR, and -0.04\u0026plusmn;0.07 logMAR, respectively. The UIVA for the DE, NE, and binocular was recorded as -0.05\u0026plusmn;0.06 logRAD, 0.00\u0026plusmn;0.10 logRAD, and -0.08\u0026plusmn;0.04 logRAD, respectively. The UNVA for the DE, NE, and binocular was recorded as 0.17\u0026plusmn;0.13 logRAD, -0.03\u0026plusmn;0.07 logRAD, and -0.05\u0026plusmn;0.07 logRAD, respectively. The 90.9% (20/22) patients achieved 0.0 logMAR or better of BUDVA, all patients achieved 0.1 logMAR or better. The 100% (22/22) patients achieved 0.0 logRAD or better of BUIVA. The 95.4% (21/22) patients achieved 0.0 logRAD or better of BUNVA. The 95.4%(21/22) of patients achieved at least 0.1 logMAR of BUDVA and 0.1 logRAD of BUNVA at the same time(\u003cstrong\u003eFig 1\u003c/strong\u003e). The improvement in UDVA,UIVA and UNVA were statistically significant (all P\u0026lt;0.05). In the DE, 9% achieved one line of CDVA improvement, 91% did not experience a CDVA decrease, 5% lost one line of CDVA in the NE, and 9% improved one line(\u003cstrong\u003eFig 2\u003c/strong\u003eand \u003cstrong\u003eFig 3\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003eThe preoperative DCNVA of the distance eye was 0.39 \u0026plusmn; 0.16 logRAD, and the postoperative was 0.39 \u0026plusmn; 0.15 logRAD, with no statistically significant difference. The preoperative DCNVA of the NE was 0.39 \u0026plusmn; 0.17 logRAD, and the postoperative one was 0.27 \u0026plusmn; 0.13 logRAD. The binocular DCNVA was 0.31 \u0026plusmn; 0.15 logRAD preoperatively and 0.23 \u0026plusmn; 0.13 logRAD postoperatively. There was no statistically significant difference in DCNVA before the operation (all \u003cem\u003eP\u003c/em\u003e \u0026gt; 0.05), while binocular and DE, NE and DE were significantly different postoperatively (\u003cem\u003eH\u003c/em\u003e=3.406, 2.536; \u003cem\u003eP\u003c/em\u003e=0.002, 0.034). The safety index (SI) for the DE was 1.01 \u0026plusmn; 0.07 and the effectiveness index (EI) was 0.98 \u0026plusmn; 0.11; for the NE eye the SI was 1.01 \u0026plusmn; 0.07 and the EI was 0.50 \u0026plusmn; 0.09.\u003c/p\u003e\n\u003cp\u003eAccuracy and stability\u003c/p\u003e\n\u003cp\u003eThe MRSE of the DE was -4.76 \u0026plusmn; 1.80D (range: \u0026minus;7.75 to -0.50 D)preoperatively and -0.18 \u0026plusmn; 0.27D(range:0.00 to -0.75 D) postoperatively. The mean SE for DE was -4.91 \u0026plusmn; 1.75D(range:-8.13 to-0.38 D) preoperatively and \u0026minus;0.45\u0026plusmn;0.30 D (range: \u0026minus;1.00 to +0.25 D) postoperatively. For the NE, the MRSE was -4.50 \u0026plusmn; 1.68D preoperatively and -1.38 \u0026plusmn; 0.35D postoperatively. The SE for DE was -4.71 \u0026plusmn; 1.87D(range:-8.38 to-0.50 D) preoperatively and \u0026minus;1.25\u0026plusmn;0.32 D (range: \u0026minus;1.75 to -0.50D) postoperatively. The target induced astigmatism(TIA) and surgically induced astigmatism(SIA) of the DE was 0.78\u0026plusmn;0.61D and 0.78\u0026plusmn;0.61D. The TIA and SIA of the NE was 0.92\u0026plusmn;0.64D and 0.91\u0026plusmn;0.58D. The target diopter of the DE was 0.00D,91% achieved \u0026plusmn;0.50D and 100% achieved \u0026plusmn;1.00D. The target diopter of the NE was -0.89D,45% achieved \u0026plusmn;0.50D,91% achieved \u0026plusmn;1.00D. The corrected astigmatism was \u0026lt;0.50D in 92% of the DE and \u0026lt;0.50D in 100% of the NE(\u003cstrong\u003eFig 2\u003c/strong\u003eand \u003cstrong\u003eFig 3\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003eContrast sensitivity and Defocus curves\u003c/p\u003e\n\u003cp\u003eCompared in logarithmic scale, the changes in binocular contrast sensitivity from the preoperative values in all test conditions were not significantly different at any frequency (all \u003cem\u003eP\u003c/em\u003e\u0026gt;0.05). (\u003cstrong\u003eFig 4\u003c/strong\u003e) .\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAt six months postoperatively, binocular defocus curve exhibited a maximum of -0.10\u0026plusmn;0.04logMAR at 0.0D, -0.00\u0026plusmn;0.12logMAR at -1.5D, and 0.20\u0026plusmn;0.16logMAR at -2.5D, with visual acuity surpassing 0.3logMAR for both eyes within the range of +1.5D to -3.0D. Postoperatively, the binocular and NE defocus curves were flatter than preoperatively in the range of 0.0D to -4.0D (\u003cstrong\u003eFig 5\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003eNAVQ, NEI VFQ-25 Questionnaire and Subjective Discomfort\u003c/p\u003e\n\u003cp\u003eThe NAVQ scores decreased from 19.36\u0026plusmn;3.55 preoperative to 4.41\u0026plusmn;2.50 postoperative, which was statistically significant \u0026nbsp; (\u003cem\u003et\u003c/em\u003e=-13.976, \u003cem\u003eP\u003c/em\u003e\u0026lt;0.001). Similarly, the NEI VFQ-25 scores significantly increased from 74.63(71.70, 79.97)pre-op to91.23(86.33, 93.24)postoperatively (\u003cem\u003eZ\u003c/em\u003e=-4.107,\u003cem\u003e\u0026nbsp;P\u003c/em\u003e\u0026lt;0.001), as shown in \u003cstrong\u003eTab 2\u003c/strong\u003e. Except for \u0026lsquo;Distance Activities\u0026rsquo; and \u0026lsquo;Peripheral Vision\u0026rsquo; showed no significant improvement following surgery, all other dimensions of the NEI VFQ-25 scale showed significant statistical differences post-surgery compared to pre-surgery (all \u003cem\u003ep\u003c/em\u003e\u0026lt;0.05).\u0026nbsp;Only one patient failed to achieve complete spectacle removal(correction was required for driving at night or in dim conditions, spectacle independence was achieved at all other times). Full spectacle independence was successfully achieved in 21 out of 22 patients. The primary discomfort reported by the patients at the postoperative follow-up was mild to moderate dry eye, fluctuating visual acuity, blurred vision and difficulty in focusing binocular vision. In the last follow-up, the vast majority of patients reported that their discomfort had subsided or disappeared, and all patients (22/22, 100%) expressed satisfaction or very satisfaction with the surgery, with satisfaction regarding near vision also reaching 100% (22/22).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;The pre- and post-operative NEI VFQ-25 results in patients\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"643\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVFQ-25 categories\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003epre\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003epost\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003eZ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eGeneral Health\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e50.00(50.00, 75.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e75.00 (75.00, 81.25)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-3.448\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.001\u003csup\u003e**\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eGeneral Vision\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e60.00(60.00,80.00)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e80.00(80.00, \u0026nbsp;80.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-4.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.000\u003csup\u003e***\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eOcular Pain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e75.00(50.00,100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e100.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-3.666\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.001\u003csup\u003e**\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eNear Activities\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e50.00(50.00,75.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e100.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-6.654\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.000\u003csup\u003e***\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eDistance Activities\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e75.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e75.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-1.843\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.065\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eVision Specific:\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eSocial Functioning\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e100.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e100.00(100.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-3.606\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.000\u003csup\u003e***\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eMental Health\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e100.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e100.00(100.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-4.593\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.000\u003csup\u003e***\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eRole Difficulties\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e75.00 (50.00, 75.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e100.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-4.465\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;0.000\u003csup\u003e***\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eDependency\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e100.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e100.00(100.00,100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-3.900\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;0.000\u003csup\u003e***\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eDriving\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e75.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e100.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-4.943\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.000\u003csup\u003e***\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eColor Vision\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e100.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e100.00(100.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-2.828\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.005\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003ePeripheral Vision\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e100.00(75.00, 100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e100.00(75.00,100.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-1.155\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.248\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003eTOTAL SCORE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 151px;\"\u003e\n \u003cp\u003e74.63(71.70, 79.97)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 161px;\"\u003e\n \u003cp\u003e91.23(86.33, 93.24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e-4.107\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 85px;\"\u003e\n \u003cp\u003e0.000\u003csup\u003e***\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" style=\"width: 643px;\"\u003e\n \u003cp\u003eActivities were modified on the translated questionnaire according to the cultural differences.\u003c/p\u003e\n \u003cp\u003eNEI VFQ-25: National Eye Institute Visual Functioning Questionnaire -25 (version 2000).\u003c/p\u003e\n \u003cp\u003eGrading scores: 100 points-No difficulty at all;75 points-A little difficulty;50 points-Moderate difficulty; 25point-Extreme difficulty; 0 point-Stopped doing this because of your eyesight; the answer treated as missing-Stopped doing this for other reasons or not interested in doing this\u003c/p\u003e\n \u003cp\u003eThe \u0026lsquo;General Health\u0026rsquo; component does not count towards the total score.\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e＜0.05*；\u003cem\u003eP\u003c/em\u003e＜0.01**; P＜0.001***\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study evaluated the efficacy of the PresbyMAX ®monocular ablation mode in 22 patients with myopia and presbyopia. None of the patients experienced a loss of two or more lines, and only one non-dominant eye showed a one-line reduction in CDVA. Following the surgical procedure, the patient's distance, intermediate, and near vision exhibited a significant improvement compared to pre-operation levels, aligning with recent findings in published research\u003csup\u003e[17, 25]\u003c/sup\u003e. Binocular vision outcomes have demonstrated stability since the first month post-operation. Unlike the previous central PresbyLASIK\u003csup\u003e[11, 26]\u003c/sup\u003etechnology, the excimer laser micro-monovision multifocal bi-aspheric ablation mode utilizes 7-Dimensional Eye Tracking System to ensure precise alignment of the optical axis, pupil, and corneal apex during surgery, thereby mitigating postoperative issues related to distance vision and contrast sensitivity decline\u003csup\u003e[16]\u003c/sup\u003e, which was confirmed by the results of this study. In a retrospective study, Chan et al. \u003csup\u003e[18]\u003c/sup\u003ediscovered that 14% of patients necessitated additional treatment following presbyopia correction using this technique. This may be attributed to the surgical design employing a lower ADD and the occurrence of postoperative corneal epithelial remodeling. Furthermore, it has been demonstrated that the mean annual progression of hyperopic drift in eyes treated with corneal multifocal ablation is +0.1D\u003csup\u003e[27\u003c/sup\u003e\u003csup\u003e]\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eBy incorporating various lenses in front of the eye to induce defocus and plotting defocus curves, it is feasible to replicate diverse visual requirements at varying distances. The defocus curve is frequently employed for assessing the efficacy of multifocal or adjustable intraocular lenses\u003csup\u003e[28, 29]\u003c/sup\u003e, as well as for evaluating the impact of corneal surgery on presbyopia correction\u003csup\u003e[27, 30]\u003c/sup\u003e. Research has demonstrated a notable decline in the defocus curve of patients in the early stages of presbyopia at intermediate and near distances\u003csup\u003e[31]\u003c/sup\u003e\u003csup\u003e,\u003c/sup\u003e with preoperative results aligning with this conclusion. The results of this study revealed that at 6mo post-surgery, there was no statistically significant difference among the monocular and binocular within the range of +2.0D to 0.0D. In the 0.0D to -4D range, the binocular defocus curves exhibited no significant difference from those of the NE and demonstrated a significantly superior performance compared to those of the dominant eye. The binocular and NE curves displayed a flatter profile, a finding that holds clinical significance. This suggests that employing micro-monovision with multifocal non-spherical ablation significantly enhances near to mid-distance vision while exerting minimal influence on the CDVA of binocular eyes. Luger et al.\u003csup\u003e[19, 27]\u003c/sup\u003eobserved that the defocus curve could still reach preoperative levels after more than six years of long-term follow-up, which is similar to the results of this study.\u0026nbsp;It did not exhibit the multi-peak characteristics,\u0026nbsp;here corneal\u0026nbsp;“multifocality”\u0026nbsp;are considered\u0026nbsp;“synonymous wanted effects”\u0026nbsp;sought as a compensation for presbyopia (in a continuous progressive manner), and should not be mixed up with a stepwise multifocality generally termed bifocality, tri-focality used in reading spectacles or IOLs.\u0026nbsp; The changes in the curve, combined with the improvement in DCNVA, indicate an increase in depth of focus for\u0026nbsp;binocular\u0026nbsp;and the NE.\u0026nbsp;In practical applications, the accuracy of defocus curves is influenced by various factors, including patient tolerance. If a patient experiences fatigue, the accuracy of the defocus curve decreases significantly. Furthermore, variables such as age, accommodative function, pupil diameter, contrast sensitivity, and higher-order aberrations can also impact the outcomes\u003csup\u003e[32]\u003c/sup\u003e\u003csup\u003e.\u003c/sup\u003e Subsequent research could integrate additional indicators into the defocus curve or optimize the examination process to improve precision.\u003c/p\u003e\n\u003cp\u003eThe results of the subjective scales(NAVQ and NEI VFQ-25) showed significant improvement after surgery. Furthermore, the assessment using the NEI VFQ-25 scale revealed that the surgery had a multidimensional positive impact on the patients. The improvement in the total score and\u0026nbsp;“General Vision”\u0026nbsp;score clearly reflects an increase in patient satisfaction regarding their overall visual function. Additionally, the rise in scores for dimensions such as\u0026nbsp;“Ocular Pain”,\u0026nbsp;“Near Activities”,\u0026nbsp;“Social Functioning”,\u0026nbsp;“Mental Health”, and\u0026nbsp;“Dependency”\u0026nbsp;on others indicates that the surgery not only achieved excellent results in vision quality but also significantly improved the patients' quality of life. Postoperative improvements in vision have effectively enhanced the perception of overall health, alleviated eye discomfort, and reduced negative emotions such as anxiety and depression. Moreover, the enhancement of vision has led to better social participation and performance among patients, decreased dependence on others, and increased self-efficacy, further promoting patients' physical and mental well-being. Postoperatively, the most commonly reported visual discomforts were blurred vision, decreased night vision, glare, and dry eye symptoms, consistent with findings from previous studies\u003csup\u003e[17, 19]\u003c/sup\u003e.\u0026nbsp; they still reported satisfaction after using artificial tears or wearing corrective lenses. These symptoms will gradually diminish or disappear within three to six months, in conjunction with restoration of visual balance in both eyes, restoration of ocular surface health, and appropriate use of perioperative medications. Furthermore, only one patient in this study required the use of corrective lenses for distance vision in the evening or while driving at night following surgery. This may be attributed to the patient's larger scotopic pupil diameter and the higher ADD employed in the procedure. The remaining patients were able to achieve spectacle independence. The daily visual performance of presbyopic patients is significantly correlated with factors such as gender, occupation and reading habits, e.g. patients with longer arms can somewhat reduce the need for near vision aids. \u0026nbsp;In recent years, there has been an increasing frequency of presbyopic patients participating in activities at both near and intermediate distances\u003csup\u003e[33]\u003c/sup\u003e, further heightening the demand for good intermediate and near vision. In this study, a high proportion of patients were engaged in occupations such as accounting and teaching, which require extensive computer use and close-up work. The aforementioned findings indicate that it is crucial to strictly adhere to surgical indications and fully consider patient needs. During the surgical design phase, personalized ADD should be incorporated for the patient. In preoperative communication, it is important to emphasize to the patient the potential visual discomforts that may occur in the early postoperative period, such as fluctuations in vision and blurred vision, over the first 3 to 6 months. In certain specific situations, patients may still require vision correction. This approach can help set reasonable expectations for the surgery, effectively alleviating patient anxiety and enhancing overall satisfaction.\u003c/p\u003e\n\u003cp\u003eThe limitations of this study include a relatively small sample size, which restricts the scope of the research. Future studies should include a larger number of patients, particularly those with other refractive errors combined with presbyopia, as well as patients with isolated presbyopia. Additionally, this study only measured the defocus curves after correction, failing to reflect the real-world performance of patients without correction. Subsequent research will combine measurements of uncorrected defocus curves, accommodative function, aberrations, Strehl ratio, and stereopsis to provide a more comprehensive assessment of visual quality.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn conclusion, the excimer laser micro-monovision multifocal bi-spherical ablation mode is a secure and efficacious approach for presbyopia correction. It has demonstrated significant enhancements in both distance and near vision, leading to high levels of patient satisfaction. While some patients may initially experience symptoms such as blurred vision, reduced night vision, glare, and dry eyes following the procedure, these discomforts typically diminish or resolve over time.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is a consecutive case series study conducted at a single center and follows the guidelines set forth in the Declaration of Helsinki. It has been approved by the Ethics Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine (HEC-KS-2020003KY), registered with the Chinese Clinical Trial Registry under the number \u0026quot;ChiCTR2300074821,\u0026quot; and written informed consent was obtained from all study participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot Applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData is provided within the manuscript or supplementary information files\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eShandong Province Medical and Health Science and Technology Development Program (No. 202207020806)，awarded to Dr. Peng Ji.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eP.J. conducted the conception and design of the study and approved the final version of the manuscript; L.L. performed the examinations during each follow-up, drafted the work, analyzed the data, and revised the manuscript. X.W. performed the examinations during each follow-up and analyzed the data; X.W., H.F., and H.B. conducted the conception, design of the study and interpretation of data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe thank the medical staff of the Department of Refractive Surgery, Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine for their support of this research.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWolffsohn JS, Davies LN, Presbyopia. Effectiveness of correction strategies. 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J Ophthalmol. 2023;2023:6440954. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1155/2023/6440954\u003c/span\u003e\u003cspan address=\"10.1155/2023/6440954\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"presbyopia, presbyLASIK, visual acuity, Multifocal, Bi-aspheric","lastPublishedDoi":"10.21203/rs.3.rs-5995145/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5995145/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose : \u003c/strong\u003eThis study aimed to evaluate the vision performance of the monocular \u0026nbsp;multifocal bi-aspheric ablation pattern (PresbyMAX® monocular mode) for correcting myopia and presbyopia.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eConsecutive case series, a total of 22 consecutive patients (10 males and 12 females) who underwent multifocal bi-aspheric ablation in the non-dominant eye(Near vision Eye, NE) and mono-focal regular FS-LASIK in the dominant eye(Distance vision Eye, DE) for correction of myopia and presbyopia were reviewed for 6 months. Visual acuity assessments, encompassing uncorrected distance (UDVA), intermediate (UIVA), near (UNVA), and distance corrected near visual acuity (DCNVA), were conducted preoperatively and at 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively. Additionally, the patients' primary complaints, contrast sensitivity (CS), defocus curves, and subjective questionnaires were also assessed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eBinocular UDVA (BUDVA) averaged -0.02±0.06 logMAR, binocular UIVA (BUIVA) and binocular UNVA(BUNVA) at -0.07±0.05 logRAD and -0.05±0.06 logRAD, respectively. All patients achieved BUDVA of 0.1 logMAR or better, BUIVA of 0 logRAD or better, and BUNVA of 0.1 logRAD or better, along with improved subjective ratings.CS exhibited no significant changes. Defocus curves indicated satisfactory visual acuity, with visual acuity surpassing 0.3logMAR for both eyes within the range of +1.5D to -3.0D. Common reported issues included blurred vision, glare, and dry eye symptoms. Overall, patient satisfaction was reported at 100%, with 95% of individuals achieving independence from spectacles.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions: \u003c/strong\u003eThe PresbyMAX monocular ablation mode is safe and effective for myopic patients with presbyopia, leading to high levels of patient satisfaction.\u003c/p\u003e","manuscriptTitle":"Postoperative assessment of monocular multifocal bi-aspheric ablation pattern for correcting myopia with presbyopia","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-14 23:06:25","doi":"10.21203/rs.3.rs-5995145/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5329d6fe-1d16-4eb1-8dbe-3b7fb202957d","owner":[],"postedDate":"April 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-11-04T06:38:16+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-14 23:06:25","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5995145","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5995145","identity":"rs-5995145","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}