Modified sutureless flanged intrascleral intraocular lens fixation in pediatric patients: clinical outcomes over 2 years of follow-up

Modified sutureless flanged intrascleral intraocular lens fixation in pediatric patients: clinical outcomes over 2 years of follow-up | 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 Modified sutureless flanged intrascleral intraocular lens fixation in pediatric patients: clinical outcomes over 2 years of follow-up Yuxin Fang, Yan Ma, Ying Cui, Dan Zhou This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9052057/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 To evaluate the long-term visual and anatomical outcomes of modified sutureless flanged intrascleral intraocular lens (IOL) fixation in pediatric patients with insufficient capsular or zonular support. Methods This retrospective case series study included pediatric patients (≤18 years) who underwent flanged intrascleral IOL fixation between January 2022 and Augest 2023 at Beijing Tongren Hospital, with a minimum of 2 years of follow-up. All patients underwent a complete ophthalmic examination. IOL tilt and decentration were automatedly measured by swept-source anterior segment optical coherence tomography, and haptic intrascleral visibility was graded as none or invisible (Grade 0), mild or slight (Grade I), and moderate or obvious (Grade II). Results Fifteen eyes from 11 patients (mean age, 11.5 ± 4.1 years) were included, with a mean follow-up of 29.0 ± 4.4 months. At the final visit, the mean best-corrected visual acuity (BCVA) improved from 0.75 ± 0.57 to 0.21 ± 0.18 logMAR (t = 3.867, P = 0.002). Mean IOL tilt and decentration were 3.99 ± 2.50° and 0.35 ± 0.35 mm, respectively. Haptic visibility was graded as Grade 0 in 13.6%, Grade I in 72.7%, Grade II in 13.6%. There is no case requiring IOL repositioning. Conclusions Sutureless flanged intrascleral IOL fixation demonstrated favorable long-term visual outcomes and excellent IOL stability in pediatric patients. Systematic grading of haptic intrascleral visibility confirmed stable scleral embedding. This technique provides a safe and effective alternative to sutured fixation for secondary IOL implantation in children. Pediatric patients without capsular or zonular support Modified Yamane technique Haptic stability Anterior segment optical coherence tomography Long-term follow-up Figures Figure 1 Figure 2 Figure 3 Key message What Was Known Sutureless flanged intrascleral intraocular lens fixation (Yamane technique) is an effective alternative to sutured scleral fixation in eyes without capsular support, with good intraocular lens centration and avoidance of late suture-related complications. What is new This study provides long-term (more than 2 years) outcomes of a modified sutureless flanged intrascleral intraocular lens fixation technique in pediatric patients, demonstrating sustained visual improvement and stable intraocular lens positioning. It introduces a simplified postoperative grading of haptic intrascleral visibility in children, suggesting that mild visibility may represent an optimal balance between secure docking and safe scleral embedding. Objective anterior segment optical coherence tomography measurements confirm minimal intraocular lens tilt and decentration, supporting the long-term positional stability of this technique in growing eyes. Introduction The management of aphakia in pediatric patients remains a surgical challenge, especially in cases with insufficient capsular or zonular support caused by congenital anomalies, trauma, or previous intraocular surgery. Although various techniques for secondary intraocular lens (IOL) implantation have been described—including anterior chamber IOLs, iris-claw fixation, and transscleral sutured fixation—each approach carries distinct risks in children, such as endothelial cell loss, chronic inflammation, suture-related complications, and the potential need for future reoperations due to ocular growth.[ 1 – 5 ] Scleral-sutured fixation of posterior chamber IOLs has long been regarded as the preferred option for both adults and children with insufficient capsular support.[ 6 – 10 ] However, this method carries several drawbacks, including suture erosion, late suture breakage, and IOL dislocation. These complications are of particular concern in pediatric patients, given their longer life expectancy and higher activity levels. To overcome these limitations, Yamane et al.[ 11 ] introduced a sutureless flanged intrascleral IOL fixation with double needle technique that secures the haptics within self-sealing scleral tunnels, eliminating the need for sutures or glue. Numerous studies have since demonstrated its efficacy and safety in adults, showing good IOL position and fewer long-term complications compared with sutured fixation.[ 12 – 15 ] However, reports of this technique in pediatric patients remain limited.[ 16 , 17 ] The structural and biomechanical properties of the pediatric sclera—thinner, less rigid, and more elastic than in adults[ 18 , 19 ]—may influence the stability of flanged haptic fixation. Furthermore, children have a longer life expectancy and greater ocular growth potential, raising concerns about long-term IOL position and tissue integration. Therefore, the present study aimed to evaluate the visual and anatomical outcomes of sutureless flanged intrascleral IOL fixation in pediatric patients with a minimum of two years of follow-up. Particular attention was given to IOL position assessed by anterior-segment optical coherence tomography (AS-OCT) and to haptic intrascleral visibility, to provide new insights into the long-term fixation stability of this technique in the pediatric population. Materials and Methods This is a retrospective, observational case series study recruiting pediatric patients aged ≤ 18 years who underwent suture-less flanged intrascleral IOL fixation from January 2022 to December 2023 at Beijing Tongren Hospital. All patients with a minimum of 2 years of follow-up were included. The diagnosis of the patients included ectopia lentis, IOL dislocation, and aphakia. The study protocol was approved by our local ethics committee and adhered to the Declaration of Helsinki. Informed consent for the surgical procedure was obtained from all parents or guardians of patients included in the study. Patients and members of the public were not involved in the design, conduct, reporting, or dissemination plans of this research. This study was a retrospective observational case series based on routinely collected clinical data. No patient or public contributors were involved in setting the research questions or outcome measures. All patients underwent comprehensive ophthalmic examinations preoperatively and postoperatively. The visual acuity test was obtained using a tumbling E chart, including uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and refraction. Other examinations included intraocular pressure (IOP) measurement, slit-lamp examinations, fundus examinations. The axial length (AL) was measured by IOL Master (Carl Zeiss Meditec AG, Jena, Germany). IOL power was calculated using the Barrett Universal II formula. The power was adjusted according to the patient’s age and the refractive error of the fellow eye. Surgery procedures All surgeries were performed by a single experienced vitreoretinal surgeon (Dan Zhou). The surgical technique we used and modified, based on in details by Yamane[ 11 ] and by our group[ 12 ] in a previous study. 29G needles were used in the present study instead of the 30G needles used by Dr. Yamane. All procedures were performed under general anesthesia. A 2-port or 3-port (25G) pars plana vitrectomy (PPV) was performed through sclerotomies placed 3.0–3.5 mm posterior to the limbus. Lensectomy was performed for eyes with ectopia lentis. The dislocated IOL was removed through the main corneal incision. An angled scleral tunnel was made using 29-gauge insulin syringes (BD insulin syringes, New Jersey, US) at 2.5 mm from the limbus. A 3-piece IOL, a Sensar AR40e (Johnson & Johnson Vision, Irvine, CA, USA), was inserted into the anterior chamber using an injector. The leading haptic was inserted into the lumen of the needle during the IOL implantation. A second scleral tunnel was made 180°from the first one. The trailing haptic was also inserted into the lumen of the second needle. Both haptics were externalized onto the conjunctiva. The ends of the haptics were cauterized to make a flange, and then the haptics were pushed back and docked into the scleral tunnels.(Fig. 1 ) Surgical Outcome and Evaluations Postoperatively, 1% prednisolone acetate eye drops and 0.5% levofloxacin eye drops were used for 4 times a week and continued for 2 weeks. Anti- glaucoma medications were used when required. The complications including anterior chamber hemorrhage, IOL capture, IOP elevation/ glaucoma, retinal detachment, cystoid macular edema, and endophthalmitis were noted. Postoperative examinations was performed at day 1, week 1, and months 1, 3, and 6, and every 6 months thereafter. The UCVA, BCVA, and refraction at the last visit were analyzed. Haptic visibility was graded as none or invisible (grade 0), mild or slight (grade I), and moderate or obvious (grade II), as modified from a previous study (Fig. 2 ) [ 20 ]. OCT scan for the macular area was also performed postoperatively to detect postoperative macular edema. Measurement of Intraocular Lens Tilt and decentration using AS-OCT The IOL tilting and decentration were evaluated at by swept-source AS-OCT (Casia2, Tomey Corporation, Nagoya, Japan). The measurement method was based on previously reported techniques.[ 11 , 12 ]. The Casia2 system provides an automated analysis of IOL outlines, tilt, and decentration relative to the corneal topographic axis. In this study, horizontal scans (0–180°) were used for the analysis. Statistical analysis For statistical analyses, we applied a statistical software package (SPSS version 24.0 IBM-SPSS, Chicago, IL). We first described the distribution of the main parameters by calculating their median or means and standard deviations. The paired t-test was used to compare preoperative and postoperative ocular parameters. The correlations between postoperative BCVA and the degree of IOL tilt or decentration were evaluated using Pearson’s correlation coefficient (r). A P value < 0.05 was considered statistically significant. Results A total of 15 eyes from 11 pediatric patients (7 boys, 4 girls) were included in this study. The mean age at the time of surgery was 11.5 ± 4.1 years (range, 5–16 years). The mean follow-up duration was 29.0 ± 4.4 months (range, 25–39 months). The indications for intraocular lens fixation were ectopia lentis secondary to Marfan syndrome(7 eyes, 46.7%), aphakia (7 eyes, 46.7%) due to open globe injury (4 eyes, 26.7%) or previous lens removal because of ectopia lentis (3 eyes, 20%; ), and IOL dislocation (1 eye, 6.7%). The demographic and clinical characteristics of the patients are summarized in Table 1 . Preoperatively, the mean UCVA was 1.27 ± 0.45 logMAR and the mean BCVA was 0.75 ± 0.57 logMAR. The mean axial length was 25.6 ± 2.1mm. Table 1 Clinical characteristics and surgical outcomes of eyes in pediatric patients with sutureless flanged intrascleral intraocular lens (IOL) fixation Characteristic Patients 15 eyes (11 patients) Age 11.5 ± 4.1 years (range, 5–16 years) Sex Female 4 (36.4%) Male 7 (63.6%) Indications for IOL fixation Ectopia lentis secondary to Marfan syndrome 7 eyes (46.7%) Aphakia 7 eyes (46.7%) Open globe injury 4 eyes (26.7%) Previous congenital cataract/ lens removal 3 eyes (20%), IOL dislocation 1 eye (6.7%). Pre-op UCVA 1.27 ± 0.45 Pre-op BCVA 0.75 ± 0.57 Post-op UCVA 0.75 ± 0.57 Post-op BCVA 0.21 ± 0.18 IOL tilt 3.99 ± 2.50° (range, 0.5 to 7.9°) IOL decentration 0.35 ± 0.35 mm (range, 0.01 to 0.7) Haptic intrascleral visibility Grade 0 (none or invisible) 13.6% Grade I (mild or slight) 72.7% Grade II (moderate or obvious) 13.6% Mean spherical equivalent at the final visit −0.27 ± 1.1 D Follow-up years 29.0 ± 4.4 months (range, 25–39 months) UCVA= uncorrected visual acuity, BCVA=best-corrected visual acuity. During the surgery, anterior vitrectomy was performed in all eyes except for the eyes that had previously undergone vitrectomized. Other concurrent surgical procedures as required, such as core vitrectomy, lensectomy, IOL removal, retinal endolaser, and pupilloplasty. No major intraoperative complications occurred, except in one eye (6.7%) that experienced transient iris capture of the IOL, which resolved spontaneously without affecting visual outcomes. Elevated IOP refractory to maximal anti-glaucoma therapy was found in 1 eye(6.7%) at 8 months postoperatively and was subsequently managed with glaucoma drainage implant surgery. No cases of cysoid macular edema were detected at any postoperative visit. There is no case requiring repositioning of the IOL. At the final visit, the mean UCVA improved significantly to 0.75 ± 0.57 (range, 0.05 to 0.82), and the mean BCVA improved to 0.21 ± 0.18 (range, 0.05 to 0.70). Both UCVA and BCVA at the last follow-up were significantly better than their preoperative values (UCVA: t = 8.937, P < 0.001; BCVA: t = 3.867, P = 0.002). Overall, all eyes demonstrated visual improvement, with eyes affected by ectopia lentis showing greater benefit compared with those with other etiologies(ectopia lentis: 0.17 logMAR, open globe injury : 0.30 logMAR; IOL dislocation:0.22 logMAR). Two of three eyes (66.7%) achieved BCVA better than 0.5 (≤ 0.3 logMAR). Among the remaining eyes with final BCVA below 0.5, two had residual corneal scarring secondary to open globe injury, one had band-shaped keratopathy, and one- in a patient with Marfan syndrome- had long-standing amblyopia.The mean spherical equivalent at the final visit was − 0.27 ± 1.1 D. Using AS-OCT, the mean horizontal IOL tilt was 3.99 ± 2.50°(range, 0.5 to 7.9°), and the mean horizontal decentration was 0.35 ± 0.35 mm(range, 0.01 to 0.7). No significant correlation was found between IOL tilt or decentration and postoperative BCVA(r =-0.129, P = 0.674; r =-0.372, P = 0.211). For horizontal decentration, 53.8% of eyes were displaced temporally, while 46.2% were displaced nasally.(Fig. 3 ) Regarding haptic intrascleral visibility, grading was assessed on both nasal and temporal sides, with Grade 0 in 13.6%, Grade I in 72.7%, Grade II in 13.6%. No cases of conjunctival erosion, haptic exposure, or local inflammation were observed throughout the follow-up period. Discussion This study demonstrated that the modified Yamane technique provides favorable visual and anatomical outcomes in pediatric patients with aphakia or insufficient zonular or capsular support. To the best of our knowledge, this is the first study to evaluate the long-term outcomes (≥ 2 years) of sutureless flanged intrascleral intraocular lens fixation in Chinese pediatric patients. All eyes achieved improved visual acuity, and no major intraoperative or vision-threatening postoperative complications were observed during follow-up of 29 months. These findings suggest that this technique is a safe and effective alternative for pediatric patients requiring secondary IOL implantation in various conditions, including Marfan syndrome, traumatic aphakia, and IOL dislocation. In 2017, Yamane et al.[ 11 ] introduced a novel sutureless flanged intrascleral intraocular lens (IOL) fixation technique for eyes with insufficient zonular or capsular support. Since then, hundreds of studies have demonstrated its efficacy and safety in adult populations.[ 21 ] However, only a limited number of reports have evaluated this technique in pediatric patients. Sternfeld et al.[ 16 ] first described its use in 12 eyes, showing good visual outcomes and few complications after a mean follow-up of 8 months. Recently, Ucar et al.[ 17 ] evaluated 21 eyes of 16 children who underwent a modified “flattened flange” technique and reported significant visual improvement with a mean IOL tilt of 3.2° ± 3.1°. In line with previous studies, our results also demonstrated favorable outcomes in both visual acuity and IOL stability after minimum of 2-year follow-up. Even in eyes with unilateral traumatic aphakia and corneal scarring, postoperative BCVA reached a relatively useful level (mean BCVA: 0.30 logMAR), which may facilitate subsequent amblyopia therapy and support visual development during the critical period of childhood.In such cases, iris defects were frequently present due to prior trauma, and pupilloplasty was also performed during the surgical procedures, resulting in improved visual function. Long-term suture-related complications, such as suture breakage and erosion, have been reported to occur progressively over time—typically after 3.5–10 years,[ 9 , 22 ] —with the highest incidence reaching 27.9% at 4 years of follow-up.[ 23 ] Those compliacaitons are almost unavoidable to some extent, even with modifications such as alternative suture materials, using scleral flaps, or employing Z-suture techniques.[ 24 ] In contrast, the Yamane technique relies on the mechanical fixation of the flanged haptics within self-sealing scleral tunnels, without the use of sutures or glue. This technique involves a considerable learning curve. The creation of a proper scleral tunnel—with adequate length, depth, and angulation—is critical to ensure firm haptic fixation. While several studies have documented haptic exposure or erosion as a potential complication after the Yamane technique.[ 13 , 25 ] Haptic exposure is usually attributed to inadequate scleral tunnel depth, insufficient conjunctival coverage, or gradual scleral thinning. Ucar et al.[ 17 ] suggested that using flattened flanged intrascleral IOL fixation, a modification of the Yamane technique, prevents IOL dislocation and haptic exposure. The long-term stability of the haptics is one of the key concerns in this approach. Few studies have systematically graded haptic intrascleral visibility across all cases, especially in pediatric patients. In our study, haptic intrascleral visibility was assessed on both nasal and temporal sides. Most eyes demonstrated Grade I haptic visibility, whereas complete invisibility (Grade 0) was relatively uncommon. We consider mild haptic visibility (Grade I) to represent the optimal postoperative state, particularly in pediatric eyes. A slight prominence of the haptic end may indicate firm docking and secure fixation within the scleral tunnel, ensuring mechanical IOL stability. In contrast, complete invisibility (Grade 0) could result from excessively deep haptic embedding, which may increase the risk of gradual haptic migration or slippage, especially in the thinner and more compliant sclera of children. Therefore, Grade I visibility likely reflects the best balance between adequate scleral embedding and durable fixation strength in the growing pediatric eye. Nevertheless, there is currently no standardized criterion for postoperative assessment of haptic intrascleral visibility, and further studies are warranted to establish an objective grading system and evaluate its correlation with long-term stability. Although Yamame tachqiue has shown excellent stability in adults, it may theoretically be at higher risk of gradual haptic migration or flange extrusion due to ongoing ocular growth and weaker scleral rigidity in pediatric patients. Despite these concerns, our findings showed excellent long-term stability, with no evidence of progressive IOL tilt, decentration, or change in haptic visibility over more than two years of follow-up. Several factors may explain the stable fixation observed in our pediatric cohort. First, the use of a 29-gauge needle instead of the original 30-gauge design creates a slightly wider but more friction force scleral tunnel, enhancing mechanical engagement between the haptic and the scleral wall. This tight fit likely reduces micromovement of the flange and prevents gradual haptic migration. Second, the vigorous wound-healing response and higher fibroblastic activity in the pediatric sclera may promote fibrous encapsulation of the haptic ends, contributing to long-term biological integration. Third, the relatively thick and vascularized conjunctival and Tenon’s tissue coverage in children provides an additional barrier that protects against flange exposure or erosion. Although Grade II visibility is not considered ideal in pediatric cases, it may still be relatively safe compared in elderly patients, as the thicker conjunctiva provide additional protection against haptic exposure. Together, these mechanical and biological factors likely account for the excellent stability and biocompatibility of the flanged intrascleral fixation technique in pediatric eyes, even in the context of ongoing ocular growth. AS-OCT analysis in our series also demonstrated good IOL stability, with a mean horizontal tilt of 3.99° and decentration of 0.35 mm, consistent with previous reports.[ 11 , 12 , 17 ] Longer follow-up is warranted to further validate the long-term stability and safety of the fixation in pediatric eyes. The incidence of postoperative complications was low. One eye after open globe rupture resulting in iris defect developed secondary glaucoma at 8 months after IOL fixation, but was successfully managed with drainage implant surgery. Transient iris capture occurred in one case. Iris capture after flanged intrascleral IOL fixation is mainly caused by a shallow or anteriorly placed scleral tunnel, which positions the IOL optic too close to the iris. Previous studies commonly used entry sites 1.5 or 2.0 mm posterior to the limbus, while Moore et al. recommended 1.5–2.5 mm depending on axial length. In our series, the entry site was placed 2.5 mm from the limbus, which may have reduced the risk of iris capture. IOL stability and centration were not affected. This study has several limitations. First, it was a retrospective case series with a relatively small sample size, which may limit the generalizability of the findings. Second, although all surgeries were performed by a single experienced surgeon, reducing variability in surgical technique, this also limits the ability to assess the reproducibility of outcomes across surgeons with different levels of experience. Third, the mean follow-up period was just over two years; thus, potential late-onset complications such as haptic erosion or IOL dislocation beyond this period could not be fully evaluated. Prospective multicenter studies with longer follow-up are warranted to further validate these findings, especially in the pediatric population. In summary, sutureless flanged intrascleral intraocular lens fixation demonstrated favorable long-term outcomes in pediatric patients, with stable IOL position, improved visual acuity, and minimal postoperative complications. Moreover, systematic grading of haptic intrascleral visibility in our study confirmed satisfactory scleral embedding and long-term stability. These findings suggest that flanged intrascleral fixation is a safe and effective alternative to sutured fixation in pediatric aphakia, provided that careful surgical planning and precise tunnel creation are ensured. Declarations Conflict of Interest Statement The authors have no conflicts of interest to declare. Funding This work was supported by the National Natural Science Foundation of China (82301210) Author Contribution FYX was responsible for collecting data and writing of the original draft. MY and CY was responsible fo analysis and interpretation of data. 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Eye (Lond) 35:2930–2961. 10.1038/s41433-021-01571-5 Pakravan P, Patel V, Chau V, Rohowetz L, Lai J, Fan KC, Al-Khersan H, Melo IM, Muni RH, Tsao SW, Kaplan R, Jung JJ, Hoyek S, Patel NA, Kuriyan AE, Laura DM, Mantopoulos D, Syed ZA, Yannuzzi NA (2023) Haptic Erosion Following Sutureless Scleral-fixated Intraocular Lens Placement. Ophthalmol Retina 7:333–337. 10.1016/j.oret.2022.10.015 Additional Declarations No competing interests reported. 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-9052057","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":610755158,"identity":"dae1eda2-4039-442d-8bd9-192f9f5061e3","order_by":0,"name":"Yuxin Fang","email":"","orcid":"","institution":"Beijing Tongren Eye Center, Capital Medical University","correspondingAuthor":false,"prefix":"","firstName":"Yuxin","middleName":"","lastName":"Fang","suffix":""},{"id":610755159,"identity":"7c26b456-cad5-4eb8-8b83-00114ec75286","order_by":1,"name":"Yan Ma","email":"","orcid":"","institution":"Beijing Tongren Eye Center, Capital Medical University","correspondingAuthor":false,"prefix":"","firstName":"Yan","middleName":"","lastName":"Ma","suffix":""},{"id":610755161,"identity":"7ddf3d19-869d-4ac9-a219-ce0cc2f58d58","order_by":2,"name":"Ying Cui","email":"","orcid":"","institution":"Beijing Tongren Eye Center, Capital Medical University","correspondingAuthor":false,"prefix":"","firstName":"Ying","middleName":"","lastName":"Cui","suffix":""},{"id":610755164,"identity":"eda7d34c-429c-4b2a-bc40-ad6608cb021e","order_by":3,"name":"Dan Zhou","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4UlEQVRIie3PsWrDMBCA4TMCZRHReoaSvoJCIeRxThg8tZDRQ2gCKfYQBa/tW2TsaC+ig7p7VN4g2Tw2mRsiZ8ugb76fuwOIogfEZX1sqMdVPdq0noplOBljM/UHM0++jM2UdzacTIBepp4Xyb57naWHDzbgMGhyJIEs/aRZodccZLWl2wlbW6Q5cil83unvJ0D3uw9sacvLFpFWZDvtOCh8CyUZR+KIqtHlQpdsSJIzdU6U+sk4DEvQJV4bpNRYhuSsCP7yXBto+/6d5Kg+nfpiOZHV7nbyj7hvPIqiKLrqD2xvStJxSYWlAAAAAElFTkSuQmCC","orcid":"","institution":"Beijing Tongren Eye Center, Capital Medical University","correspondingAuthor":true,"prefix":"","firstName":"Dan","middleName":"","lastName":"Zhou","suffix":""}],"badges":[],"createdAt":"2026-03-06 15:23:28","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9052057/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9052057/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":105351881,"identity":"15cdb109-3322-49a8-8de9-617d623c8c8b","added_by":"auto","created_at":"2026-03-25 05:59:47","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":21445875,"visible":true,"origin":"","legend":"\u003cp\u003eThe main surgerical steps of the modified flanged Intrascleral Intraocular lens (IOL) fixation. A, Angled scleral tunnel created 2.5 mm from the limbus using a 29-gauge needle. B, Introduction of the leading haptic into the lumen of the 29-gauge needle during the IOL implantation. C, Externalization of the first haptic. D. Cauterization of the first haptic to make a flange. E. A second scleral tunnel was made 180°from the first one. F.The trailing haptic was also inserted into the lumen of a 29-gauge needle. G, Externalization of the trailing haptic.H. Cauterization of the trailing haptic to make a flange.I. Pushing back of the two haptics to be docked into the scleral tunnels.\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-9052057/v1/c6be99b3784884f1c655135f.png"},{"id":105351880,"identity":"3603bb7e-0e73-4401-baf8-152fb95d2b6d","added_by":"auto","created_at":"2026-03-25 05:59:46","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":3911007,"visible":true,"origin":"","legend":"\u003cp\u003eGrading of haptic visibility. A. grade 0: none or invisible. B. grade I (arrow):mild or slight.C. grade II (arrowhead): moderate or obvious.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-9052057/v1/9c094bd401b7e139c7318a38.png"},{"id":105351879,"identity":"9ece0a41-5758-4fae-bc31-009c0d16320a","added_by":"auto","created_at":"2026-03-25 05:59:46","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":655675,"visible":true,"origin":"","legend":"\u003cp\u003eThe assessment of intraocular lens (IOL) using anterior segment optical coherence tomography A. The decentering and tilt of the IOL wasautomated analyzed. B. The flange of the IOL haptic is docked into the sclera tunnels.\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-9052057/v1/3b333e62946b6e85154e5f91.png"},{"id":105351882,"identity":"7bddc2f8-b665-4c8b-afaf-cbf50c536bc0","added_by":"auto","created_at":"2026-03-25 06:00:01","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":24718314,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9052057/v1/81ff480f-ed7d-4e7b-81be-96165ddcc12a.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Modified sutureless flanged intrascleral intraocular lens fixation in pediatric patients: clinical outcomes over 2 years of follow-up","fulltext":[{"header":"Key message","content":"\u003cp\u003e\u003cstrong\u003eWhat Was Known\u003c/strong\u003e\u003c/p\u003e\n\u003cul start=\"50\"\u003e\n \u003cli\u003eSutureless flanged intrascleral intraocular lens fixation (Yamane technique) is an effective alternative to sutured scleral fixation in eyes without capsular support, with good intraocular lens centration and avoidance of late suture-related complications.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eWhat is new\u003c/strong\u003e\u003c/p\u003e\n\u003cul start=\"50\"\u003e\n \u003cli\u003eThis study provides long-term (more than 2 years) outcomes of a modified sutureless flanged intrascleral intraocular lens fixation technique in pediatric patients, demonstrating sustained visual improvement and stable intraocular lens positioning.\u003c/li\u003e\n \u003cli\u003eIt introduces a simplified postoperative grading of haptic intrascleral visibility in children, suggesting that mild visibility may represent an optimal balance between secure docking and safe scleral embedding.\u003c/li\u003e\n \u003cli\u003eObjective anterior segment optical coherence tomography measurements confirm minimal intraocular lens tilt and decentration, supporting the long-term positional stability of this technique in growing eyes.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Introduction","content":"\u003cp\u003eThe management of aphakia in pediatric patients remains a surgical challenge, especially in cases with insufficient capsular or zonular support caused by congenital anomalies, trauma, or previous intraocular surgery. Although various techniques for secondary intraocular lens (IOL) implantation have been described\u0026mdash;including anterior chamber IOLs, iris-claw fixation, and transscleral sutured fixation\u0026mdash;each approach carries distinct risks in children, such as endothelial cell loss, chronic inflammation, suture-related complications, and the potential need for future reoperations due to ocular growth.[\u003cspan additionalcitationids=\"CR2 CR3 CR4\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eScleral-sutured fixation of posterior chamber IOLs has long been regarded as the preferred option for both adults and children with insufficient capsular support.[\u003cspan additionalcitationids=\"CR7 CR8 CR9\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] However, this method carries several drawbacks, including suture erosion, late suture breakage, and IOL dislocation. These complications are of particular concern in pediatric patients, given their longer life expectancy and higher activity levels. To overcome these limitations, Yamane et al.[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] introduced a sutureless flanged intrascleral IOL fixation with double needle technique that secures the haptics within self-sealing scleral tunnels, eliminating the need for sutures or glue. Numerous studies have since demonstrated its efficacy and safety in adults, showing good IOL position and fewer long-term complications compared with sutured fixation.[\u003cspan additionalcitationids=\"CR13 CR14\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eHowever, reports of this technique in pediatric patients remain limited.[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] The structural and biomechanical properties of the pediatric sclera\u0026mdash;thinner, less rigid, and more elastic than in adults[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u0026mdash;may influence the stability of flanged haptic fixation. Furthermore, children have a longer life expectancy and greater ocular growth potential, raising concerns about long-term IOL position and tissue integration.\u003c/p\u003e \u003cp\u003eTherefore, the present study aimed to evaluate the visual and anatomical outcomes of sutureless flanged intrascleral IOL fixation in pediatric patients with a minimum of two years of follow-up. Particular attention was given to IOL position assessed by anterior-segment optical coherence tomography (AS-OCT) and to haptic intrascleral visibility, to provide new insights into the long-term fixation stability of this technique in the pediatric population.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003eThis is a retrospective, observational case series study recruiting pediatric patients aged\u0026thinsp;\u0026le;\u0026thinsp;18 years who underwent suture-less flanged intrascleral IOL fixation from January 2022 to December 2023 at Beijing Tongren Hospital. All patients with a minimum of 2 years of follow-up were included. The diagnosis of the patients included ectopia lentis, IOL dislocation, and aphakia. The study protocol was approved by our local ethics committee and adhered to the Declaration of Helsinki. Informed consent for the surgical procedure was obtained from all parents or guardians of patients included in the study. Patients and members of the public were not involved in the design, conduct, reporting, or dissemination plans of this research. This study was a retrospective observational case series based on routinely collected clinical data. No patient or public contributors were involved in setting the research questions or outcome measures.\u003c/p\u003e \u003cp\u003eAll patients underwent comprehensive ophthalmic examinations preoperatively and postoperatively. The visual acuity test was obtained using a tumbling E chart, including uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and refraction. Other examinations included intraocular pressure (IOP) measurement, slit-lamp examinations, fundus examinations. The axial length (AL) was measured by IOL Master (Carl Zeiss Meditec AG, Jena, Germany). IOL power was calculated using the Barrett Universal II formula. The power was adjusted according to the patient\u0026rsquo;s age and the refractive error of the fellow eye.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eSurgery procedures\u003c/h2\u003e \u003cp\u003eAll surgeries were performed by a single experienced vitreoretinal surgeon (Dan Zhou). The surgical technique we used and modified, based on in details by Yamane[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] and by our group[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] in a previous study. 29G needles were used in the present study instead of the 30G needles used by Dr. Yamane.\u003c/p\u003e \u003cp\u003eAll procedures were performed under general anesthesia. A 2-port or 3-port (25G) pars plana vitrectomy (PPV) was performed through sclerotomies placed 3.0\u0026ndash;3.5 mm posterior to the limbus. Lensectomy was performed for eyes with ectopia lentis. The dislocated IOL was removed through the main corneal incision. An angled scleral tunnel was made using 29-gauge insulin syringes (BD insulin syringes, New Jersey, US) at 2.5 mm from the limbus. A 3-piece IOL, a Sensar AR40e (Johnson \u0026amp; Johnson Vision, Irvine, CA, USA), was inserted into the anterior chamber using an injector. The leading haptic was inserted into the lumen of the needle during the IOL implantation. A second scleral tunnel was made 180\u0026deg;from the first one. The trailing haptic was also inserted into the lumen of the second needle. Both haptics were externalized onto the conjunctiva. The ends of the haptics were cauterized to make a flange, and then the haptics were pushed back and docked into the scleral tunnels.(Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eSurgical Outcome and Evaluations\u003c/h3\u003e\n\u003cp\u003ePostoperatively, 1% prednisolone acetate eye drops and 0.5% levofloxacin eye drops were used for 4 times a week and continued for 2 weeks. Anti- glaucoma medications were used when required. The complications including anterior chamber hemorrhage, IOL capture, IOP elevation/ glaucoma, retinal detachment, cystoid macular edema, and endophthalmitis were noted. Postoperative examinations was performed at day 1, week 1, and months 1, 3, and 6, and every 6 months thereafter. The UCVA, BCVA, and refraction at the last visit were analyzed. Haptic visibility was graded as none or invisible (grade 0), mild or slight (grade I), and moderate or obvious (grade II), as modified from a previous study (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. OCT scan for the macular area was also performed postoperatively to detect postoperative macular edema.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e\n\u003ch3\u003eMeasurement of Intraocular Lens Tilt and decentration using AS-OCT\u003c/h3\u003e\n\u003cp\u003eThe IOL tilting and decentration were evaluated at by swept-source AS-OCT (Casia2, Tomey Corporation, Nagoya, Japan). The measurement method was based on previously reported techniques.[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. The Casia2 system provides an automated analysis of IOL outlines, tilt, and decentration relative to the corneal topographic axis. In this study, horizontal scans (0\u0026ndash;180\u0026deg;) were used for the analysis.\u003c/p\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eFor statistical analyses, we applied a statistical software package (SPSS version 24.0 IBM-SPSS, Chicago, IL). We first described the distribution of the main parameters by calculating their median or means and standard deviations. The paired t-test was used to compare preoperative and postoperative ocular parameters. The correlations between postoperative BCVA and the degree of IOL tilt or decentration were evaluated using Pearson\u0026rsquo;s correlation coefficient (r). A P value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 15 eyes from 11 pediatric patients (7 boys, 4 girls) were included in this study. The mean age at the time of surgery was 11.5\u0026thinsp;\u0026plusmn;\u0026thinsp;4.1 years (range, 5\u0026ndash;16 years). The mean follow-up duration was 29.0\u0026thinsp;\u0026plusmn;\u0026thinsp;4.4 months (range, 25\u0026ndash;39 months). The indications for intraocular lens fixation were ectopia lentis secondary to Marfan syndrome(7 eyes, 46.7%), aphakia (7 eyes, 46.7%) due to open globe injury (4 eyes, 26.7%) or previous lens removal because of ectopia lentis (3 eyes, 20%; ), and IOL dislocation (1 eye, 6.7%). The demographic and clinical characteristics of the patients are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Preoperatively, the mean UCVA was 1.27\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45 logMAR and the mean BCVA was 0.75\u0026thinsp;\u0026plusmn;\u0026thinsp;0.57 logMAR. The mean axial length was 25.6\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1mm.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eClinical characteristics and surgical outcomes of eyes in pediatric patients with sutureless flanged intrascleral intraocular lens (IOL) fixation\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatients\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15 eyes (11 patients)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11.5\u0026thinsp;\u0026plusmn;\u0026thinsp;4.1 years (range, 5\u0026ndash;16 years)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (36.4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (63.6%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndications for IOL fixation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEctopia lentis secondary to Marfan syndrome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 eyes (46.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAphakia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 eyes (46.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOpen globe injury\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 eyes (26.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious congenital cataract/ lens removal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 eyes (20%),\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIOL dislocation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 eye (6.7%).\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePre-op UCVA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.27\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePre-op BCVA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.75\u0026thinsp;\u0026plusmn;\u0026thinsp;0.57\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePost-op UCVA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.75\u0026thinsp;\u0026plusmn;\u0026thinsp;0.57\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePost-op BCVA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.21\u0026thinsp;\u0026plusmn;\u0026thinsp;0.18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIOL tilt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.99\u0026thinsp;\u0026plusmn;\u0026thinsp;2.50\u0026deg; (range, 0.5 to 7.9\u0026deg;)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIOL decentration\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.35\u0026thinsp;\u0026plusmn;\u0026thinsp;0.35 mm (range, 0.01 to 0.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHaptic intrascleral visibility\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 0 (none or invisible)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade I (mild or slight)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e72.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade II (moderate or obvious)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean spherical equivalent at the final visit\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026minus;0.27\u0026thinsp;\u0026plusmn;\u0026thinsp;1.1 D\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFollow-up years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29.0\u0026thinsp;\u0026plusmn;\u0026thinsp;4.4 months (range, 25\u0026ndash;39 months)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003eUCVA= uncorrected visual acuity, BCVA=best-corrected visual acuity.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eDuring the surgery, anterior vitrectomy was performed in all eyes except for the eyes that had previously undergone vitrectomized. Other concurrent surgical procedures as required, such as core vitrectomy, lensectomy, IOL removal, retinal endolaser, and pupilloplasty. No major intraoperative complications occurred, except in one eye (6.7%) that experienced transient iris capture of the IOL, which resolved spontaneously without affecting visual outcomes. Elevated IOP refractory to maximal anti-glaucoma therapy was found in 1 eye(6.7%) at 8 months postoperatively and was subsequently managed with glaucoma drainage implant surgery. No cases of cysoid macular edema were detected at any postoperative visit. There is no case requiring repositioning of the IOL.\u003c/p\u003e \u003cp\u003eAt the final visit, the mean UCVA improved significantly to 0.75\u0026thinsp;\u0026plusmn;\u0026thinsp;0.57 (range, 0.05 to 0.82), and the mean BCVA improved to 0.21\u0026thinsp;\u0026plusmn;\u0026thinsp;0.18 (range, 0.05 to 0.70). Both UCVA and BCVA at the last follow-up were significantly better than their preoperative values (UCVA: t\u0026thinsp;=\u0026thinsp;8.937, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001; BCVA: t\u0026thinsp;=\u0026thinsp;3.867, P\u0026thinsp;=\u0026thinsp;0.002). Overall, all eyes demonstrated visual improvement, with eyes affected by ectopia lentis showing greater benefit compared with those with other etiologies(ectopia lentis: 0.17 logMAR, open globe injury : 0.30 logMAR; IOL dislocation:0.22 logMAR). Two of three eyes (66.7%) achieved BCVA better than 0.5 (\u0026le;\u0026thinsp;0.3 logMAR). Among the remaining eyes with final BCVA below 0.5, two had residual corneal scarring secondary to open globe injury, one had band-shaped keratopathy, and one- in a patient with Marfan syndrome- had long-standing amblyopia.The mean spherical equivalent at the final visit was \u0026minus;\u0026thinsp;0.27\u0026thinsp;\u0026plusmn;\u0026thinsp;1.1 D.\u003c/p\u003e \u003cp\u003eUsing AS-OCT, the mean horizontal IOL tilt was 3.99\u0026thinsp;\u0026plusmn;\u0026thinsp;2.50\u0026deg;(range, 0.5 to 7.9\u0026deg;), and the mean horizontal decentration was 0.35\u0026thinsp;\u0026plusmn;\u0026thinsp;0.35 mm(range, 0.01 to 0.7). No significant correlation was found between IOL tilt or decentration and postoperative BCVA(r =-0.129, P\u0026thinsp;=\u0026thinsp;0.674; r =-0.372, P\u0026thinsp;=\u0026thinsp;0.211). For horizontal decentration, 53.8% of eyes were displaced temporally, while 46.2% were displaced nasally.(Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e) Regarding haptic intrascleral visibility, grading was assessed on both nasal and temporal sides, with Grade 0 in 13.6%, Grade I in 72.7%, Grade II in 13.6%. No cases of conjunctival erosion, haptic exposure, or local inflammation were observed throughout the follow-up period.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study demonstrated that the modified Yamane technique provides favorable visual and anatomical outcomes in pediatric patients with aphakia or insufficient zonular or capsular support. To the best of our knowledge, this is the first study to evaluate the long-term outcomes (\u0026ge;\u0026thinsp;2 years) of sutureless flanged intrascleral intraocular lens fixation in Chinese pediatric patients. All eyes achieved improved visual acuity, and no major intraoperative or vision-threatening postoperative complications were observed during follow-up of 29 months. These findings suggest that this technique is a safe and effective alternative for pediatric patients requiring secondary IOL implantation in various conditions, including Marfan syndrome, traumatic aphakia, and IOL dislocation.\u003c/p\u003e \u003cp\u003eIn 2017, Yamane et al.[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] introduced a novel sutureless flanged intrascleral intraocular lens (IOL) fixation technique for eyes with insufficient zonular or capsular support. Since then, hundreds of studies have demonstrated its efficacy and safety in adult populations.[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] However, only a limited number of reports have evaluated this technique in pediatric patients. Sternfeld et al.[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] first described its use in 12 eyes, showing good visual outcomes and few complications after a mean follow-up of 8 months. Recently, Ucar et al.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] evaluated 21 eyes of 16 children who underwent a modified \u0026ldquo;flattened flange\u0026rdquo; technique and reported significant visual improvement with a mean IOL tilt of 3.2\u0026deg; \u0026plusmn; 3.1\u0026deg;. In line with previous studies, our results also demonstrated favorable outcomes in both visual acuity and IOL stability after minimum of 2-year follow-up. Even in eyes with unilateral traumatic aphakia and corneal scarring, postoperative BCVA reached a relatively useful level (mean BCVA: 0.30 logMAR), which may facilitate subsequent amblyopia therapy and support visual development during the critical period of childhood.In such cases, iris defects were frequently present due to prior trauma, and pupilloplasty was also performed during the surgical procedures, resulting in improved visual function.\u003c/p\u003e \u003cp\u003eLong-term suture-related complications, such as suture breakage and erosion, have been reported to occur progressively over time\u0026mdash;typically after 3.5\u0026ndash;10 years,[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] \u0026mdash;with the highest incidence reaching 27.9% at 4 years of follow-up.[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] Those compliacaitons are almost unavoidable to some extent, even with modifications such as alternative suture materials, using scleral flaps, or employing Z-suture techniques.[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] In contrast, the Yamane technique relies on the mechanical fixation of the flanged haptics within self-sealing scleral tunnels, without the use of sutures or glue. This technique involves a considerable learning curve. The creation of a proper scleral tunnel\u0026mdash;with adequate length, depth, and angulation\u0026mdash;is critical to ensure firm haptic fixation. While several studies have documented haptic exposure or erosion as a potential complication after the Yamane technique.[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] Haptic exposure is usually attributed to inadequate scleral tunnel depth, insufficient conjunctival coverage, or gradual scleral thinning. Ucar et al.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] suggested that using flattened flanged intrascleral IOL fixation, a modification of the Yamane technique, prevents IOL dislocation and haptic exposure.\u003c/p\u003e \u003cp\u003eThe long-term stability of the haptics is one of the key concerns in this approach. Few studies have systematically graded haptic intrascleral visibility across all cases, especially in pediatric patients. In our study, haptic intrascleral visibility was assessed on both nasal and temporal sides. Most eyes demonstrated Grade I haptic visibility, whereas complete invisibility (Grade 0) was relatively uncommon. We consider mild haptic visibility (Grade I) to represent the optimal postoperative state, particularly in pediatric eyes. A slight prominence of the haptic end may indicate firm docking and secure fixation within the scleral tunnel, ensuring mechanical IOL stability. In contrast, complete invisibility (Grade 0) could result from excessively deep haptic embedding, which may increase the risk of gradual haptic migration or slippage, especially in the thinner and more compliant sclera of children. Therefore, Grade I visibility likely reflects the best balance between adequate scleral embedding and durable fixation strength in the growing pediatric eye. Nevertheless, there is currently no standardized criterion for postoperative assessment of haptic intrascleral visibility, and further studies are warranted to establish an objective grading system and evaluate its correlation with long-term stability.\u003c/p\u003e \u003cp\u003eAlthough Yamame tachqiue has shown excellent stability in adults, it may theoretically be at higher risk of gradual haptic migration or flange extrusion due to ongoing ocular growth and weaker scleral rigidity in pediatric patients. Despite these concerns, our findings showed excellent long-term stability, with no evidence of progressive IOL tilt, decentration, or change in haptic visibility over more than two years of follow-up. Several factors may explain the stable fixation observed in our pediatric cohort. First, the use of a 29-gauge needle instead of the original 30-gauge design creates a slightly wider but more friction force scleral tunnel, enhancing mechanical engagement between the haptic and the scleral wall. This tight fit likely reduces micromovement of the flange and prevents gradual haptic migration. Second, the vigorous wound-healing response and higher fibroblastic activity in the pediatric sclera may promote fibrous encapsulation of the haptic ends, contributing to long-term biological integration. Third, the relatively thick and vascularized conjunctival and Tenon\u0026rsquo;s tissue coverage in children provides an additional barrier that protects against flange exposure or erosion. Although Grade II visibility is not considered ideal in pediatric cases, it may still be relatively safe compared in elderly patients, as the thicker conjunctiva provide additional protection against haptic exposure. Together, these mechanical and biological factors likely account for the excellent stability and biocompatibility of the flanged intrascleral fixation technique in pediatric eyes, even in the context of ongoing ocular growth. AS-OCT analysis in our series also demonstrated good IOL stability, with a mean horizontal tilt of 3.99\u0026deg; and decentration of 0.35 mm, consistent with previous reports.[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] Longer follow-up is warranted to further validate the long-term stability and safety of the fixation in pediatric eyes.\u003c/p\u003e \u003cp\u003eThe incidence of postoperative complications was low. One eye after open globe rupture resulting in iris defect developed secondary glaucoma at 8 months after IOL fixation, but was successfully managed with drainage implant surgery. Transient iris capture occurred in one case. Iris capture after flanged intrascleral IOL fixation is mainly caused by a shallow or anteriorly placed scleral tunnel, which positions the IOL optic too close to the iris. Previous studies commonly used entry sites 1.5 or 2.0 mm posterior to the limbus, while Moore et al. recommended 1.5\u0026ndash;2.5 mm depending on axial length. In our series, the entry site was placed 2.5 mm from the limbus, which may have reduced the risk of iris capture. IOL stability and centration were not affected.\u003c/p\u003e \u003cp\u003eThis study has several limitations. First, it was a retrospective case series with a relatively small sample size, which may limit the generalizability of the findings. Second, although all surgeries were performed by a single experienced surgeon, reducing variability in surgical technique, this also limits the ability to assess the reproducibility of outcomes across surgeons with different levels of experience. Third, the mean follow-up period was just over two years; thus, potential late-onset complications such as haptic erosion or IOL dislocation beyond this period could not be fully evaluated. Prospective multicenter studies with longer follow-up are warranted to further validate these findings, especially in the pediatric population.\u003c/p\u003e \u003cp\u003eIn summary, sutureless flanged intrascleral intraocular lens fixation demonstrated favorable long-term outcomes in pediatric patients, with stable IOL position, improved visual acuity, and minimal postoperative complications. Moreover, systematic grading of haptic intrascleral visibility in our study confirmed satisfactory scleral embedding and long-term stability. These findings suggest that flanged intrascleral fixation is a safe and effective alternative to sutured fixation in pediatric aphakia, provided that careful surgical planning and precise tunnel creation are ensured.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003cstrong\u003eConflict of Interest Statement\u003c/strong\u003e \u003cp\u003eThe authors have no conflicts of interest to declare.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThis work was supported by the National Natural Science Foundation of China (82301210)\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eFYX was responsible for collecting data and writing of the original draft. MY and CY was responsible fo analysis and interpretation of data. ZD contributed to conception, design of the study,and revising the manuscript . All authors read and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWagoner MD, Cox TA, Ariyasu RG, Jacobs DS, Karp CL, American Academy of O (2003) Intraocular lens implantation in the absence of capsular support: a report by the American Academy of Ophthalmology. Ophthalmology 110:840\u0026ndash;859. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/s0161-6420(02)02000-6\u003c/span\u003e\u003cspan address=\"10.1016/s0161-6420(02)02000-6\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLalwani S, Kekunnaya R (2023) Secondary Intraocular Lens Implantation (IOL) in Children- What, Why, When, and How? 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Ophthalmol Retina 7:333\u0026ndash;337. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.oret.2022.10.015\u003c/span\u003e\u003cspan address=\"10.1016/j.oret.2022.10.015\" 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":"Pediatric patients without capsular or zonular support, Modified Yamane technique, Haptic stability, Anterior segment optical coherence tomography, Long-term follow-up","lastPublishedDoi":"10.21203/rs.3.rs-9052057/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9052057/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo evaluate the long-term visual and anatomical outcomes of modified sutureless flanged intrascleral intraocular lens (IOL) fixation in pediatric patients with insufficient capsular or zonular support.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis retrospective case series study included pediatric patients (≤18 years) who underwent flanged intrascleral IOL fixation between January 2022 and Augest 2023 at Beijing Tongren Hospital, with a minimum of 2 years of follow-up. All patients underwent a complete ophthalmic examination. IOL tilt and decentration were automatedly measured by swept-source anterior segment optical coherence tomography, and haptic intrascleral visibility was graded as none or invisible (Grade 0), mild or slight (Grade I), and moderate or obvious (Grade II).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFifteen eyes from 11 patients (mean age, 11.5 ± 4.1 years) were included, with a mean follow-up of 29.0 ± 4.4 months. At the final visit, the mean best-corrected visual acuity (BCVA) improved from 0.75 ± 0.57 to 0.21 ± 0.18 logMAR (t = 3.867, P = 0.002). Mean IOL tilt and decentration were 3.99 ± 2.50° and 0.35 ± 0.35 mm, respectively. Haptic visibility was graded as Grade 0 in 13.6%, Grade I in 72.7%, Grade II in 13.6%. There is no case requiring IOL repositioning.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSutureless flanged intrascleral IOL fixation demonstrated favorable long-term visual outcomes and excellent IOL stability in pediatric patients. Systematic grading of haptic intrascleral visibility confirmed stable scleral embedding. This technique provides a safe and effective alternative to sutured fixation for secondary IOL implantation in children.\u003c/p\u003e","manuscriptTitle":"Modified sutureless flanged intrascleral intraocular lens fixation in pediatric patients: clinical outcomes over 2 years of follow-up","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-25 05:59:42","doi":"10.21203/rs.3.rs-9052057/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":"9d4205f4-44f1-4b55-8306-680dbfd30e5e","owner":[],"postedDate":"March 25th, 2026","published":true,"recentEditorialEvents":[{"type":"decision","content":"Revision requested","date":"2026-05-12T10:14:52+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-11T19:57:28+00:00","index":31,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-05-12T10:54:04+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-25 05:59:42","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9052057","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9052057","identity":"rs-9052057","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}