Effects of Ultrasound Cycloplasty in Glaucoma Patients:6-Month Results From a Prospective Clinical Study

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Ultrasound cycloplasty significantly reduced intraocular pressure, medication use, and pain in glaucoma patients over six months without serious complications, though anterior keratometry temporarily changed.

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Effects of Ultrasound Cycloplasty in Glaucoma Patients:6-Month Results From a Prospective Clinical Study | 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 Effects of Ultrasound Cycloplasty in Glaucoma Patients:6-Month Results From a Prospective Clinical Study Liu Li, Ying-Jie Li, Ling Hong, Yong-Bo Wang, Xuan Zhu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4113871/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 Objectives To explore effects of ultrasound cycloplasty (UCP) in glaucoma patients, aiming to evaluate the efficacy and safety of UCP. Methods Twenty-two glaucoma patients (23 eyes) who received UCP treatment at the Ophthalmology Department of Nanchang First Hospital from July 2020 to September 2022 were selected.Intraocular pressure (IOP), number of anti-glaucoma agents, best corrected visual acuity (BCVA) and eye pain scores of the patients before and 1, 3, 7 days, 1, 3 and 6 months after treatment were recorded.The complications during treatment and after treatment were also observed.The corneal curvature, pupil size, corneal thickness and anterior chamber depth of pentacam before and 1 day, 1 and 6 months after treatment were measured. Results The preoperative IOP, number of anti-glaucoma agents, and eye pain scores were 37.35 ± 13.79 mmHg, average 3.35 ± 1.23 and 4.39 ± 2.15, which were decreased significantly at each time point after UCP treatment ( P < 0. 01). The IOP decrease rates were 33.31%, 45.68%, 46.32%, 47.23%, 41.93%, and 48.46%, respectively. The postoperative IOP reduction at 1, 3 and 7 days, 1, 3 and 6 months were significantly correlated with preoperative IOP ( r = 0.719, 0.750, 0.797, 0.661,0.515 and 0.607, all P < 0.05). No serious complication was observed throughout the treatment and the follow-up.There was a temporary change in anterior keratometry 1 day after UCP treatment. BCVA, pupil diameter, corneal thickness and anterior chamber depth remained unchanged. Conclusion UCP was demonstrated to be effective in decreasing IOP, IOP-lowering medications and pain scores in patients with glaucoma. It’s well-tolerated without intraoperative or postoperative complications. Ultrasound cycloplasty Intraocular pressure Complication Anterior segment structure Glaucoma Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Introduction Glaucoma is a common blinding eye disease that can cause irreversible optic nerve damage and progressive visual field defects [ 1 ]. The most important and effective treatment currently available to alleviate visual loss is to control IOP[ 2 ], by increasing aqueous humor outflow or/and reducing aqueous humor generation[ 3 ]. Among them, cyclodestructive procedures that reduce aqueous humor generation, such as cyclophotocoagulation and cyclocryotherapy, are limited to the treatment of advanced or refractory glaucoma due to poor reproducibility and serious complications [ 4 , 5 ]. High intensity focused ultrasound (HIFU) provides a new approach for the cyclodestructive procedure. Ultrasound cycloplasty (UCP) utilizes the highly selective effect of HIFU on the ciliary body, achieving an automated computer-assisted ciliary body treatment program. The main mechanisms of focused ultrasound in the treatment of glaucoma are as follows: (1) coagulation of ciliary epithelial cells and reduction of aqueous humor secretion [ 6 ]; and (2) reorganization of scleral tissue in the treatment area leads to separation of sclera and ciliary body, thus increasing outflow of aqueous humor from the suprachoroidal space [ 7 ]. Its application and repetition do not increase the risk of complications [ 8 ]. The purpose of this study was to explore effects of UCP in glaucoma patients so as to evaluate the efficacy and safety of UCP. Subjects and methods Subjects In total 22 glaucoma patients (23 eyes) who underwent UCP treatment at the Ophthalmology Department of Nanchang First Hospital from July 2020 to September 2022 were collected in this study. Inclusion criteria was as followings: 1) Age between 18 and 80y; 2) IOP ≥ 21 mmHg after anti-glaucoma treatment or with maximum dosage of glaucoma drugs; 3) Patients who underwent UCP treatment in our hospital. Exclusion criteria was as followings: 1) History of ocular infections and uveitis; 2) Normal tension glaucoma; 3) Thin sclera or ocular tumor; 4) Patients with severe systemic diseases previously or currently who cannot tolerate UCP treatment. All patients signed informed consent forms, and the study was reviewed by the Ethics Committee of Nanchang First Hospital. UCP Procedure All surgical procedures were performed by a same experienced ophthalmologist (YJ Li). Patients received treatment with an appropriate size of probe which was selected according to the distance of horizontal ciliary process of UBM and white to white of IOL Master before treatment by machine (EyeOP1, Eye Tech Care, France). The skin around the surgical eye was disinfected routinely before treatment, the conjunctival sac was rinsed with povidone iodine and physiological saline, and treatment was performed under retrobulbar anesthesia with lidocaine. An appropriate range of the UCP sector was chosen according to patient's preoperative IOP, visual acuity, and degree of optic nerve atrophy [ 9 ]. 3:00 o'clock and 9:00 o'clock positions were avoided to protect from the anterior ciliary artery and posterior ciliary nerve branches damage. Followed-up After UCP, praprofen eye drops and tobramycin dexamethasone eye drops (4 times/day) were administered to the eyes, and the number of anti-glaucoma agents was adjusted according to the patient's intraocular pressure situation. Patients were followed up for 6 months after treatment. Intraocular pressure, the number of anti-glaucoma agents, best corrected visual acuity (LogMAR), pain scores before and 1, 3 and 7 days, 1, 3, and 6 months after treatment were recorded. The numerical rating scale (NRS) was used to score the degree of pain, with “0” representing “no pain” and “10” representing the “most severe pain imaginable” at the time of assessment [ 10 ]. And the complications during treatment and after treatment were observed. Anterior flat/steep keratometry, pupil diameter, corneal thickness and anterior chamber depth of pentacam were recorded before and 1 day, 1 and 6 months after treatment. Statistical Analysis SPSS 25.0 software (IBM, USA) was used for statistical analysis. Measurement data was represented as mean ± standard deviation and analyzed by t- test. Pearson correlation analysis was used to evaluate the correlation between preoperative IOP and postoperative IOP reduction. P < 0.05 was considered to be statistically significant. Results This study included 10 males (11 eyes) and 12 females (12 eyes), aged 24–79 years, with an average age of (56.96 ± 15.37) years. The preoperative intraocular pressure was 21–57 (37.35 ± 13.79) mmHg (1 kPa = 7.5 mmHg). Five eyes of primary open-angle glaucoma (21.74%), eight eyes of primary angle-closure glaucoma (34.78%), five eyes of secondary glaucoma (21.74%) and five eyes of neovascular glaucoma (21.74%) were selected. Two eyes were lost to follow-up 1 month after UCP treatment and three eyes were lost to follow-up 3 month after UCP treatment due to poor visual prognosis and the inconvenience of movement caused by low vision.In the telephone follow-up, the patient lost to follow-up reported a significant improvement in redness and swelling compared to before treatment. Based on the patients' data who lost to follow-up within one month after treatment and the proportion of them, we believe that it had no impact on the overall conclusion. IOP The preoperative intraocular pressure of patients was 22–57 (average 37.35 ± 13.79) mmHg. After UCP, intraocular pressure significantly decreased at 1, 3 and 7 days, 1, 3, and 6 months as compared to preoperative levels ( P < 0.01), with rates of intraocular pressure reduction were 33.31%, 45.68%, 46.32%, 47.23%, 41.93%, and 48.46%, respectively (Fig. 1 ). In addition, Pearson correlation analysis results showed that there was a correlation between postoperative intraocular pressure reduction at 1, 3 and 7 days, 1, 3 and 6 months and preoperative intraocular pressure (r = 0.719, 0.750, 0.797, 0.661,0.515 and 0.607, all P < 0.05). Number of anti-glaucoma agents Patients used 0 ~ 4 (average 3.35 ± 1.23) types of anti-glaucoma agents before treatment, and the number of anti-glaucoma agents used at each time point after treatment was significantly reduced compared to before treatment, suggesting that patients’ dependence on IOP-lowering medications after surgery was reduced ( P < 0.01, Fig. 2 ). Pain Scores The pain scores of patients at 1, 3 and 7 days, 1, 3 and 6 months after treatment were significantly lower than those before treatment ( P < 0.01). Except 1 eye, 22 eyes had varying degrees of pain before treatment. Only 1 eye showed no obvious improvement in pain, but gradually relieved after administering painkillers 1 day after treatment. At 6 months after UCP, there was no significant improvement in 1 eye of the patient, 6 eyes lessen the severity (from severe to mild or moderate pain), and the pain gradually disappeared in the remaining patients (Fig. 3 ). BCVA Compared with BCVA before treatment, there were no changes at the last follow-up in all patients. The BCVA at the last follow-up was increased in 6 patients, declined in 2 patients, and unchanged 12 patients (Fig. 4 ). Complications Five patients experienced mild to moderate pain during the treatment. The postoperative complications were relatively mild, and most of them disappeared within one month spontaneously or after medication. While scleral imprint lasted a long time and were still observed 6 months after UCP treatment (Fig. 5 , Table 2 ). Pentacam data The pupil diameter, corneal thickness and anterior chamber depth at the last follow-up was unchanged in all patients compared with those before treatment. The mean ± SD values of anterior flat/steep keratometry 1 day after treatment were different from those before treatment, while there was no difference in the mean ± SD values of steep/flat anterior keratometry between 1 and 6 months after treatment (Table 1 ). Discussion Cyclodestruction is an effective method for ophthalmologists to reduce intraocular pressure in glaucoma patients. Recently, ultrasound cycloplasty has been proved to be an effective and safe method for the treatment of glaucoma [ 11 , 12 ]. UCP generates high-intensity focused ultrasound through micro transducers, inducing ciliary body coagulation so as to treat glaucoma. The present study aimed to evaluate the efficacy of a single UCP procedure in patients with primary open-angle glaucoma, angle-closure glaucoma, secondary glaucoma, or neovascular glaucoma. Results showed that the IOP after UCP treatment at each follow-up time point was significantly lower than those before treatment. The average IOP reduced from 37.35 ± 13.79 mmHg to 24.91 ± 9.95 mmHg at day 1 and fluctuated to 19.25 ± 11.78 mmHg after 6 months. Moreover, the number of anti-glaucoma agents decreased from 3.35 ± 1.23 before treatment to 1.65 ± 1.40 (Day-1) and 1.60 ± 1.64 (Month-6). These findings are consistent with previous reports. Chen and Guo treated 61 eyes (7 POAG, 17 PACG, 26 NVG, 11 secondary glaucoma) with UCP and followed up for 18 months and found that IOP reduction was more than 60% at 1 month after UCP, and more than 30% 18 months after UCP, with a success rate of 94. 55% at 7 days after UCP, and more than 60% 18 months after UCP [ 13 ]. We did a correlation analysis and found that that there was a significant linear correlation between the decrease in postoperative intraocular pressure and preoperative intraocular pressure. It is considered to be that the higher the patient's IOP, the larger the range of ciliary body rupture set by UCP treatment parameters, resulting in a greater decrease in IOP. This indicates that UCP treatment for glaucoma can significantly reduce intraocular pressure and the number of anti-glaucoma agents. The classical treatment method for cyclodestructive therapy is cyclocryotherapy. However, this method causes significant damage to eye tissue and have many complications, as well as significant pain for patients, which limits its application in clinical practice[ 14 ].As a new type of cyclodestructive therapy,UCP has less pain after treatment.In particular, we evaluated the eye pain score in this study. We used the Numeric Rating Scale (NRS) to quantify eye pain.UCP brought significant postoperative relief of the painfulness due to reduction of IOP. The patient's eye pain score continued to decrease within 7 days after treatment, which may be related to the use of an eye speculum and tear film damage during the treatment. UCP has many advantages such as target organ selectivity and controllable thermal effects, which can focus on the ciliary tissue through the conjunctiva and sclera, producing a single point like injury with a dose-response relationship and no damage to adjacent structures. During the UCP treatment, retrobulbar anesthesia was used, and no serious complications occurred (e. g. eye atrophy and vision loss over two lines). Therefore, UCP can smoothly control intraocular pressure, and effectively reduce the complications and ciliary body damage caused by traditional treatments [ 15 ]. UCP treatment still has some complications, although not severe. The most common complications in our study were conjunctival hyperemia (47.83%), scleral imprint (39. 13%) after treatment, and mild to moderate pain (21.74%) during the treatment. Conjunctival hyperemia and induced astigmatism disappeared within one month spontaneously or after medication. Some patients experienced varying degrees of pain during the treatment, possibly due to factors such as different pain thresholds and ocular inflammation preoperatively. Scleral imprint is a relatively rare complication for UCP treatment in some studies [ 16 ], but it is common in this study.Some researchers suggested that scleral imprint was a sign of scleral thinning [ 17 ]. But in this study, all patients with scleral imprints did not show any other signs of scleral thinning, such as staphyloma until the end of follow-up.Also in Bartłomiej’s study,he treated 78 patients with primary and secondary refractory glaucoma with UCP, and found that scleral thickness in superior scleral mark increased after UCP and reduced to its initial value without significant difference after the procedure [ 18 ]. A underwent UBM examination on the scleral imprint found that sclera is not obviously thinner but interlayer structure is sparse[ 19 ].Rodolfo Mastropasqua found formation of new (or the enlargement of preexisting) intrascleral hyporeflective spaces after UCP through anterior segment optical coherence tomography[ 20 ].We suggest there may be a histological rearrangement, which may explain the gray appearance found under slit lamp.It deserves our attention and long-term observation. The UCP affects corneal parameters immediately after the procedure, but this change may be temporary, since all parameters returned to their initial values at 1 month after treatment, which is considered to be acceptable clinically. Similarly, Bolek’s study enrolled 78 patients with glaucoma and found that there was a significant difference in the anterior keratometry after UCP, which disappeared 3 months postoperatively [ 19 ]. Furthermore,a study conduted by Deb-Joardar[ 17 ] mentioned that the surgically induce astigmatism after UCP was transient.In clinical practice, these changes after UCP treatment may be caused by sclera [ 18 ]. We also found scleral imprints after UCP, but the scleral imprints did not disappear throughout the follow-up.Thus we speculated that changes in anterior keratometry may be related to cases where the ultrasound probe was too close to the limbus, rather than changes in the sclera. This also indicates that the cornea has recoverable biological characteristics.Of course, further clinical research is required. The limitations of this study include: (1) The follow-up time was short and some patients were lost to followed up,so the long-term effect is still uncertain; (2) The sample size is relatively small; (3) We did not compare the efficacy with other ciliary body destructive surgeries or glaucoma surgeries; (4) Heterogeneity in glaucoma types and baseline IOP levels. Further research is in progress to investigate IOP control with long term follow-up. Conclusion As a non-invasive treatment, UCP is effective and safe for IOP control in glaucoma. After UCP treatment, IOP, number of anti-glaucoma agents, and eye pain scores decreased. UCP showed no permanent obvious effect on the anterior segment structure. Declarations Author’ Contribution All author contributed to the conception of this study. Li Liu contributed to data analysis and wrote the manuscript. All surgical procedures were performed by Ying-Jie Li. Ling Hong collected the data. Yong-Bo Wang elaborated the figures. Xuan Zhu contributed to the interpretation. All authors read and approved the final manuscript. Funding This work was supported by the Science and Technology Department of Jiangxi Province (Grant No. 20212BAG70033). Consent for publication Informed consent for publication of identifiable information/ images in open access journal was obtained from all study participants. Conflicts of interest The authors declare that they have no conflict of interest. Ethical approval All experimental protocols were approved by Ethics Committee of Nanchang First Hospital. Informed consent was obtained from all subjects. Availability of data and materials The data that support the findings of this study is available on request from the corresponding author upon reasonable request. References Jonas JB, Aung T, Bourne RR, Bron AM, Ritch R, Panda-Jonas S. Glaucoma. Lancet. 2017;390 (10108):2183-2193. Liang YB, Jiang JH, Wang NL. A review of epidemiological investigation and research on glaucoma in China. Chin J Ophthalmol, 2019, 55 (8): 634-640. European Glaucoma Society Terminology and Guidelines for Glaucoma, 4th Edition - Chapter 3: Treatment principles and options Supported by the EGS Foundation: Part 1: Foreword; Introduction; Glossary; Chapter 3 Treatment principles and options. Br J Ophthalmol. 2017;101 (6):130-195. Lanzagorta-Aresti A, Montolío-Marzo S, Davó-Cabrera JM, Piá-Ludeña JV. Transscleral versus endoscopic cyclophotocoagulation outcomes for refractory glaucoma. Eur J Ophthalmol. 2021;31 (3):1107-1112. Ruixue W, Tao W, Ning L. A comparative study between ultrasound cycloplasty and cyclocryotherapy for the treatment of neovascular glaucoma. J Ophthalmol. 2020;2020:4016536. Cao H, Xu Z, Long H, et al. Trans-catheter arterial chemoembolization in combination with high-intensity focused ultrasound for unresectable hepatocellular carcinoma: a systematic review and meta-analysis of the Chinese literature. Ultrasound Med Biol 2011; 3 (7): 1009–1016. Mastopasqua R, Agnifili L, Fasanella V, et al. Uveo-scleral outflow pathways after ultrasonic cyclocoagulation in refractory glaucoma: an anterior segment optical coherence tomography and in vivo confocal study. Br J Ophthalmol 2016; 100 (12): 1668–1675. Morais Sarmento T, Figueiredo R, Garrido J, Passos I, Rebelo AL, Candeias A. Ultrasonic circular cyclocoagulation prospective safety and effectiveness study. Int Ophthalmol. 2021;41 (9):3047-3055. Fan FF, Ge X, Liu DD, Xu TY, Wang RX, Chen XY, Li SY. Comparison of the efficacy and safety of ultrasonic cycloplasty vs valve implantation and anti-VEGF for the treatment of fundus disease-related neovascular glaucoma. Int J Ophthalmol. 2023 Jun 18;16(6):897-903. doi: 10.18240/ijo.2023.06.10. PMID: 37332547; PMCID: PMC10250935. Bielewicz J, Daniluk B, Kamieniak P. VAS and NRS, Same or Different? Are Visual Analog Scale Values and Numerical Rating Scale Equally Viable Tools for Assessing Patients after Microdiscectomy? Pain Res Manag. 2022 Mar 29;2022:5337483. doi: 10.1155/2022/5337483. PMID: 35391853; PMCID: PMC8983264. Almobarak FA, Alrubean A, Alsarhani WK, Aljenaidel A, Osman EA. Outcomes of Ultrasound Cyclo Plasty in Primary Angle Closure Glaucoma. J Glaucoma. 2023 May 1;32(5):407-413. doi: 10.1097/IJG.0000000000002182. Epub 2023 Feb 3. PMID: 36795514. 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Application of high intensity focused ultrasound for treatment of open-angle glaucoma in Indian patients. Indian J Ophthalmol 2018; 66(4): 517–523. Bolek B, Wylęgała A, Wylęgała E. Assessment of scleral and conjunctival thickness of the eye after ultrasound ciliary plasty. J Ophthalmol. 2020;24;2020:9659014. Zhou LF, Hu Die,Lan Jie, et al. Efficacy and safety of single Ultrasound Cyclo-Plasty to treat refractory glaucoma: Results at 1 year. Eur J Ophthalmol. 2022 Jan;32(1):268-274. doi: 10.1177/1120672120973605. Epub 2020 Nov 22. PMID: 33225725. Mastropasqua R, Agnifili L, Fasanella V, Toto L, Brescia L, Di Staso S, Doronzo E, Marchini G. Uveo-scleral outflow pathways after ultrasonic cyclocoagulation in refractory glaucoma: an anterior segment optical coherence tomography and in vivo confocal study. Br J Ophthalmol. 2016 Dec;100(12):1668-1675. doi: 10.1136/bjophthalmol-2015-308069. Epub 2016 Feb 16. PMID: 26883868. Tables Table 1 Anterior flat and steep keratometry 1 day, 1 month, and 6 months after UCP treatment Time N anterior flat keratometry t P anterior steep keratometry t P Baseline 23 43.74 ± 2.18 - - 45.06 ± 1.44 - - Day-1 23 43.32 ± 2.05 3.657 0.001* 44.69 ± 1.35 2.468 0.022* Month-1 17 43.45 ± 2.29 1.548 0.137 45.02 ± 1.44 -0.298 0.769 Month-6 16 43.35 ± 2.20 1.436 0.167 45.22 ± 1.69 -1.636 0.118 F 0.173 0.495 P 0.915 0.687 * The difference is statistically significant. Paired t-test was used to compare single group data with preoperative data,and ANOVA test was used to compare whether the means of multiple samples were significantly different. Table 2 Intra-operative and postoperative complications. Description Number of eyes (%) Intraoperative Pain 5(21.74) Post-operative Scleral imprint 12(52.17) Conjunctival hyperemia 11(47.83) Anterior chamber inflammation 1(4.35) Hyphema 1(4.35) Additional Declarations No competing interests reported. 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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-4113871","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":281797038,"identity":"ee2d8036-efb1-4abb-b98d-c6303e45612d","order_by":0,"name":"Liu Li","email":"","orcid":"","institution":"Nanchang First Hospital","correspondingAuthor":false,"prefix":"","firstName":"Liu","middleName":"","lastName":"Li","suffix":""},{"id":281797039,"identity":"6f2098bd-478b-4f77-8082-a20f2fd4107c","order_by":1,"name":"Ying-Jie Li","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAs0lEQVRIie3PMQrCMBTG8VcD7fJK5kAPkU2EoldJEZw8RCBrD1DBczi/kKGbHsClFxDaraMp9gDPTTD/KcP3IzyAVOoXK6AhwBqltFwiwERyqlRHfAJxG2ptDVPoAEPA6oEaKBunM4MoByYgPnErrFCXG4NIsZKdpVyUHJJ/yB01GSZZf6EvyHKLv+IRVecd7xbdt83wavcHKZ0fJw4BQLMp2+WRWdY+VlA2z9xxKpVK/WVvkV8z1dbPVjwAAAAASUVORK5CYII=","orcid":"","institution":"Nanchang First Hospital","correspondingAuthor":true,"prefix":"","firstName":"Ying-Jie","middleName":"","lastName":"Li","suffix":""},{"id":281797040,"identity":"7010ed2a-6605-44ce-8131-bbace7d9ba23","order_by":2,"name":"Ling Hong","email":"","orcid":"","institution":"Nanchang First Hospital","correspondingAuthor":false,"prefix":"","firstName":"Ling","middleName":"","lastName":"Hong","suffix":""},{"id":281797041,"identity":"b4101914-3040-4bbb-83ec-376c76a4c045","order_by":3,"name":"Yong-Bo Wang","email":"","orcid":"","institution":"Nanchang First Hospital","correspondingAuthor":false,"prefix":"","firstName":"Yong-Bo","middleName":"","lastName":"Wang","suffix":""},{"id":281797042,"identity":"b2d11689-affa-4ac6-b446-9c2eced3f230","order_by":4,"name":"Xuan Zhu","email":"","orcid":"","institution":"Nanchang First Hospital","correspondingAuthor":false,"prefix":"","firstName":"Xuan","middleName":"","lastName":"Zhu","suffix":""}],"badges":[],"createdAt":"2024-03-16 15:44:24","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4113871/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4113871/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":53184686,"identity":"8a84bf78-d863-4d9a-a0e3-2be6af23b3f6","added_by":"auto","created_at":"2024-03-21 16:06:37","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":11602,"visible":true,"origin":"","legend":"\u003cp\u003eChange of intraocular pressure after UCP treatment\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-4113871/v1/c73f896b205a156d8b5e9e9c.png"},{"id":53184687,"identity":"8b0f908b-88b1-431e-ace2-823fd6deac66","added_by":"auto","created_at":"2024-03-21 16:06:37","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":12457,"visible":true,"origin":"","legend":"\u003cp\u003eNumber of anti-glaucoma agents\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-4113871/v1/7ca95d0d506ee00199337d75.png"},{"id":53184688,"identity":"da0b6bde-09ca-483b-9180-44aa2d3c4a78","added_by":"auto","created_at":"2024-03-21 16:06:37","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":11789,"visible":true,"origin":"","legend":"\u003cp\u003ePain scores of patients at 1,3 and 7 days, 1, 3 and 6 months after treatment\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-4113871/v1/aa6f80e85808d241e71cc9ab.png"},{"id":53184690,"identity":"1c9e945d-0b04-49af-9691-491fcbd71951","added_by":"auto","created_at":"2024-03-21 16:06:37","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":12050,"visible":true,"origin":"","legend":"\u003cp\u003eChange of best corrected visual acuity after UCP treatment\u003c/p\u003e","description":"","filename":"floatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-4113871/v1/99d5e2a685df315835dba0dd.png"},{"id":53186022,"identity":"c530bc5a-25a8-45c1-be18-58c24b242361","added_by":"auto","created_at":"2024-03-21 16:14:37","extension":"jpeg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":30405,"visible":true,"origin":"","legend":"\u003cp\u003eScleral imprint observed 6 months after UCP treatment. Black arrow shows scleral imprint.\u003c/p\u003e","description":"","filename":"floatimage5.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4113871/v1/1981e5a6c4383b533940ae14.jpeg"},{"id":70752599,"identity":"f8afbf73-5b92-4018-b76f-bc16b481b408","added_by":"auto","created_at":"2024-12-06 09:38:29","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":456553,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4113871/v1/1684d767-5ae6-4cdc-8c97-881116cf4144.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effects of Ultrasound Cycloplasty in Glaucoma Patients:6-Month Results From a Prospective Clinical Study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eGlaucoma is a common blinding eye disease that can cause irreversible optic nerve damage and progressive visual field defects [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The most important and effective treatment currently available to alleviate visual loss is to control IOP[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], by increasing aqueous humor outflow or/and reducing aqueous humor generation[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Among them, cyclodestructive procedures that reduce aqueous humor generation, such as cyclophotocoagulation and cyclocryotherapy, are limited to the treatment of advanced or refractory glaucoma due to poor reproducibility and serious complications [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. High intensity focused ultrasound (HIFU) provides a new approach for the cyclodestructive procedure. Ultrasound cycloplasty (UCP) utilizes the highly selective effect of HIFU on the ciliary body, achieving an automated computer-assisted ciliary body treatment program. The main mechanisms of focused ultrasound in the treatment of glaucoma are as follows: (1) coagulation of ciliary epithelial cells and reduction of aqueous humor secretion [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]; and (2) reorganization of scleral tissue in the treatment area leads to separation of sclera and ciliary body, thus increasing outflow of aqueous humor from the suprachoroidal space [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Its application and repetition do not increase the risk of complications [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe purpose of this study was to explore effects of UCP in glaucoma patients so as to evaluate the efficacy and safety of UCP.\u003c/p\u003e"},{"header":"Subjects and methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eSubjects\u003c/h2\u003e \u003cp\u003eIn total 22 glaucoma patients (23 eyes) who underwent UCP treatment at the Ophthalmology Department of Nanchang First Hospital from July 2020 to September 2022 were collected in this study. Inclusion criteria was as followings: 1) Age between 18 and 80y; 2) IOP\u0026thinsp;\u0026ge;\u0026thinsp;21 mmHg after anti-glaucoma treatment or with maximum dosage of glaucoma drugs; 3) Patients who underwent UCP treatment in our hospital. Exclusion criteria was as followings: 1) History of ocular infections and uveitis; 2) Normal tension glaucoma; 3) Thin sclera or ocular tumor; 4) Patients with severe systemic diseases previously or currently who cannot tolerate UCP treatment. All patients signed informed consent forms, and the study was reviewed by the Ethics Committee of Nanchang First Hospital.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eUCP Procedure\u003c/h2\u003e \u003cp\u003eAll surgical procedures were performed by a same experienced ophthalmologist (YJ Li). Patients received treatment with an appropriate size of probe which was selected according to the distance of horizontal ciliary process of UBM and white to white of IOL Master before treatment by machine (EyeOP1, Eye Tech Care, France). The skin around the surgical eye was disinfected routinely before treatment, the conjunctival sac was rinsed with povidone iodine and physiological saline, and treatment was performed under retrobulbar anesthesia with lidocaine. An appropriate range of the UCP sector was chosen according to patient's preoperative IOP, visual acuity, and degree of optic nerve atrophy [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. 3:00 o'clock and 9:00 o'clock positions were avoided to protect from the anterior ciliary artery and posterior ciliary nerve branches damage.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eFollowed-up\u003c/h2\u003e \u003cp\u003eAfter UCP, praprofen eye drops and tobramycin dexamethasone eye drops (4 times/day) were administered to the eyes, and the number of anti-glaucoma agents was adjusted according to the patient's intraocular pressure situation. Patients were followed up for 6 months after treatment. Intraocular pressure, the number of anti-glaucoma agents, best corrected visual acuity (LogMAR), pain scores before and 1, 3 and 7 days, 1, 3, and 6 months after treatment were recorded. The numerical rating scale (NRS) was used to score the degree of pain, with \u0026ldquo;0\u0026rdquo; representing \u0026ldquo;no pain\u0026rdquo; and \u0026ldquo;10\u0026rdquo; representing the \u0026ldquo;most severe pain imaginable\u0026rdquo; at the time of assessment [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. And the complications during treatment and after treatment were observed. Anterior flat/steep keratometry, pupil diameter, corneal thickness and anterior chamber depth of pentacam were recorded before and 1 day, 1 and 6 months after treatment.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eSPSS 25.0 software (IBM, USA) was used for statistical analysis. Measurement data was represented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation and analyzed by \u003cem\u003et-\u003c/em\u003etest. Pearson correlation analysis was used to evaluate the correlation between preoperative IOP and postoperative IOP reduction. \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered to be statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThis study included 10 males (11 eyes) and 12 females (12 eyes), aged 24\u0026ndash;79 years, with an average age of (56.96\u0026thinsp;\u0026plusmn;\u0026thinsp;15.37) years. The preoperative intraocular pressure was 21\u0026ndash;57 (37.35\u0026thinsp;\u0026plusmn;\u0026thinsp;13.79) mmHg (1 kPa\u0026thinsp;=\u0026thinsp;7.5 mmHg). Five eyes of primary open-angle glaucoma (21.74%), eight eyes of primary angle-closure glaucoma (34.78%), five eyes of secondary glaucoma (21.74%) and five eyes of neovascular glaucoma (21.74%) were selected.\u003c/p\u003e\n\u003cp\u003eTwo eyes were lost to follow-up 1 month after UCP treatment and three eyes were lost to follow-up 3 month after UCP treatment due to poor visual prognosis and the inconvenience of movement caused by low vision.In the telephone follow-up, the patient lost to follow-up reported a significant improvement in redness and swelling compared to before treatment. Based on the patients\u0026apos; data who lost to follow-up within one month after treatment and the proportion of them, we believe that it had no impact on the overall conclusion.\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003eIOP\u003c/h2\u003e\n \u003cp\u003eThe preoperative intraocular pressure of patients was 22\u0026ndash;57 (average 37.35\u0026thinsp;\u0026plusmn;\u0026thinsp;13.79) mmHg. After UCP, intraocular pressure significantly decreased at 1, 3 and 7 days, 1, 3, and 6 months as compared to preoperative levels (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01), with rates of intraocular pressure reduction were 33.31%, 45.68%, 46.32%, 47.23%, 41.93%, and 48.46%, respectively (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eIn addition, Pearson correlation analysis results showed that there was a correlation between postoperative intraocular pressure reduction at 1, 3 and 7 days, 1, 3 and 6 months and preoperative intraocular pressure (r\u0026thinsp;=\u0026thinsp;0.719, 0.750, 0.797, 0.661,0.515 and 0.607, all P\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003eNumber of anti-glaucoma agents\u003c/h2\u003e\n \u003cp\u003ePatients used 0\u0026thinsp;~\u0026thinsp;4 (average 3.35\u0026thinsp;\u0026plusmn;\u0026thinsp;1.23) types of anti-glaucoma agents before treatment, and the number of anti-glaucoma agents used at each time point after treatment was significantly reduced compared to before treatment, suggesting that patients\u0026rsquo; dependence on IOP-lowering medications after surgery was reduced (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01, Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n \u003ch2\u003ePain Scores\u003c/h2\u003e\n \u003cp\u003eThe pain scores of patients at 1, 3 and 7 days, 1, 3 and 6 months after treatment were significantly lower than those before treatment (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01). Except 1 eye, 22 eyes had varying degrees of pain before treatment. Only 1 eye showed no obvious improvement in pain, but gradually relieved after administering painkillers 1 day after treatment. At 6 months after UCP, there was no significant improvement in 1 eye of the patient, 6 eyes lessen the severity (from severe to mild or moderate pain), and the pain gradually disappeared in the remaining patients (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eBCVA\u003c/h2\u003e\n \u003cp\u003eCompared with BCVA before treatment, there were no changes at the last follow-up in all patients. The BCVA at the last follow-up was increased in 6 patients, declined in 2 patients, and unchanged 12 patients (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003eComplications\u003c/h2\u003e\n \u003cp\u003eFive patients experienced mild to moderate pain during the treatment. The postoperative complications were relatively mild, and most of them disappeared within one month spontaneously or after medication. While scleral imprint lasted a long time and were still observed 6 months after UCP treatment (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003e, Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n \u003ch2\u003ePentacam data\u003c/h2\u003e\n \u003cp\u003eThe pupil diameter, corneal thickness and anterior chamber depth at the last follow-up was unchanged in all patients compared with those before treatment. The mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD values of anterior flat/steep keratometry 1 day after treatment were different from those before treatment, while there was no difference in the mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD values of steep/flat anterior keratometry between 1 and 6 months after treatment (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eCyclodestruction is an effective method for ophthalmologists to reduce intraocular pressure in glaucoma patients. Recently, ultrasound cycloplasty has been proved to be an effective and safe method for the treatment of glaucoma [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. UCP generates high-intensity focused ultrasound through micro transducers, inducing ciliary body coagulation so as to treat glaucoma. The present study aimed to evaluate the efficacy of a single UCP procedure in patients with primary open-angle glaucoma, angle-closure glaucoma, secondary glaucoma, or neovascular glaucoma. Results showed that the IOP after UCP treatment at each follow-up time point was significantly lower than those before treatment. The average IOP reduced from 37.35\u0026thinsp;\u0026plusmn;\u0026thinsp;13.79 mmHg to 24.91\u0026thinsp;\u0026plusmn;\u0026thinsp;9.95 mmHg at day 1 and fluctuated to 19.25\u0026thinsp;\u0026plusmn;\u0026thinsp;11.78 mmHg after 6 months. Moreover, the number of anti-glaucoma agents decreased from 3.35\u0026thinsp;\u0026plusmn;\u0026thinsp;1.23 before treatment to 1.65\u0026thinsp;\u0026plusmn;\u0026thinsp;1.40 (Day-1) and 1.60\u0026thinsp;\u0026plusmn;\u0026thinsp;1.64 (Month-6).\u003c/p\u003e \u003cp\u003eThese findings are consistent with previous reports. Chen and Guo treated 61 eyes (7 POAG, 17 PACG, 26 NVG, 11 secondary glaucoma) with UCP and followed up for 18 months and found that IOP reduction was more than 60% at 1 month after UCP, and more than 30% 18 months after UCP, with a success rate of 94. 55% at 7 days after UCP, and more than 60% 18 months after UCP [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. We did a correlation analysis and found that that there was a significant linear correlation between the decrease in postoperative intraocular pressure and preoperative intraocular pressure. It is considered to be that the higher the patient's IOP, the larger the range of ciliary body rupture set by UCP treatment parameters, resulting in a greater decrease in IOP. This indicates that UCP treatment for glaucoma can significantly reduce intraocular pressure and the number of anti-glaucoma agents.\u003c/p\u003e \u003cp\u003eThe classical treatment method for cyclodestructive therapy is cyclocryotherapy. However, this method causes significant damage to eye tissue and have many complications, as well as significant pain for patients, which limits its application in clinical practice[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].As a new type of cyclodestructive therapy,UCP has less pain after treatment.In particular, we evaluated the eye pain score in this study. We used the Numeric Rating Scale (NRS) to quantify eye pain.UCP brought significant postoperative relief of the painfulness due to reduction of IOP. The patient's eye pain score continued to decrease within 7 days after treatment, which may be related to the use of an eye speculum and tear film damage during the treatment.\u003c/p\u003e \u003cp\u003eUCP has many advantages such as target organ selectivity and controllable thermal effects, which can focus on the ciliary tissue through the conjunctiva and sclera, producing a single point like injury with a dose-response relationship and no damage to adjacent structures. During the UCP treatment, retrobulbar anesthesia was used, and no serious complications occurred (e. g. eye atrophy and vision loss over two lines). Therefore, UCP can smoothly control intraocular pressure, and effectively reduce the complications and ciliary body damage caused by traditional treatments [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eUCP treatment still has some complications, although not severe. The most common complications in our study were conjunctival hyperemia (47.83%), scleral imprint (39. 13%) after treatment, and mild to moderate pain (21.74%) during the treatment. Conjunctival hyperemia and induced astigmatism disappeared within one month spontaneously or after medication. Some patients experienced varying degrees of pain during the treatment, possibly due to factors such as different pain thresholds and ocular inflammation preoperatively.\u003c/p\u003e \u003cp\u003eScleral imprint is a relatively rare complication for UCP treatment in some studies [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], but it is common in this study.Some researchers suggested that scleral imprint was a sign of scleral thinning [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. But in this study, all patients with scleral imprints did not show any other signs of scleral thinning, such as staphyloma until the end of follow-up.Also in Bartłomiej\u0026rsquo;s study,he treated 78 patients with primary and secondary refractory glaucoma with UCP, and found that scleral thickness in superior scleral mark increased after UCP and reduced to its initial value without significant difference after the procedure [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. A underwent UBM examination on the scleral imprint found that sclera is not obviously thinner but interlayer structure is sparse[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].Rodolfo Mastropasqua found formation of new (or the enlargement of preexisting) intrascleral hyporeflective spaces after UCP through anterior segment optical coherence tomography[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].We suggest there may be a histological rearrangement, which may explain the gray appearance found under slit lamp.It deserves our attention and long-term observation.\u003c/p\u003e \u003cp\u003eThe UCP affects corneal parameters immediately after the procedure, but this change may be temporary, since all parameters returned to their initial values at 1 month after treatment, which is considered to be acceptable clinically. Similarly, Bolek\u0026rsquo;s study enrolled 78 patients with glaucoma and found that there was a significant difference in the anterior keratometry after UCP, which disappeared 3 months postoperatively [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Furthermore,a study conduted by Deb-Joardar[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] mentioned that the surgically induce astigmatism after UCP was transient.In clinical practice, these changes after UCP treatment may be caused by sclera [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. We also found scleral imprints after UCP, but the scleral imprints did not disappear throughout the follow-up.Thus we speculated that changes in anterior keratometry may be related to cases where the ultrasound probe was too close to the limbus, rather than changes in the sclera. This also indicates that the cornea has recoverable biological characteristics.Of course, further clinical research is required.\u003c/p\u003e \u003cp\u003eThe limitations of this study include: (1) The follow-up time was short and some patients were lost to followed up,so the long-term effect is still uncertain; (2) The sample size is relatively small; (3) We did not compare the efficacy with other ciliary body destructive surgeries or glaucoma surgeries; (4) Heterogeneity in glaucoma types and baseline IOP levels. Further research is in progress to investigate IOP control with long term follow-up.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eAs a non-invasive treatment, UCP is effective and safe for IOP control in glaucoma. After UCP treatment, IOP, number of anti-glaucoma agents, and eye pain scores decreased. UCP showed no permanent obvious effect on the anterior segment structure.\u003c/p\u003e "},{"header":"Declarations","content":"\u003cp\u003eAuthor\u0026rsquo; Contribution\u003c/p\u003e\n\u003cp\u003eAll author contributed to the conception of this study. Li Liu contributed to data analysis and wrote the manuscript. All surgical procedures were performed by Ying-Jie Li. Ling Hong collected the data. Yong-Bo Wang elaborated the figures. Xuan Zhu contributed to the interpretation. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eThis work was supported by the Science and Technology Department of Jiangxi Province (Grant No. 20212BAG70033).\u003c/p\u003e\n\u003cp\u003eConsent for publication\u003c/p\u003e\n\u003cp\u003eInformed consent for publication of identifiable information/ images in open access journal was obtained from all study participants.\u003c/p\u003e\n\u003cp\u003eConflicts of interest\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003eEthical approval\u003c/p\u003e\n\u003cp\u003eAll experimental protocols were approved by Ethics Committee of Nanchang First Hospital. Informed consent was obtained from all subjects.\u003c/p\u003e\n\u003cp\u003eAvailability of data and materials\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study is available on request from the corresponding author upon reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eJonas JB, Aung T, Bourne RR, Bron AM, Ritch R, Panda-Jonas S. Glaucoma. Lancet. 2017;390 (10108):2183-2193. \u003c/li\u003e\n\u003cli\u003eLiang YB, Jiang JH, Wang NL. A review of epidemiological investigation and research on glaucoma in China. Chin J Ophthalmol, 2019, 55 (8): 634-640. \u003c/li\u003e\n\u003cli\u003eEuropean Glaucoma Society Terminology and Guidelines for Glaucoma, 4th Edition - Chapter 3: Treatment principles and options Supported by the EGS Foundation: Part 1: Foreword; Introduction; Glossary; Chapter 3 Treatment principles and options. Br J Ophthalmol. 2017;101 (6):130-195. \u003c/li\u003e\n\u003cli\u003eLanzagorta-Aresti A, Montol\u0026iacute;o-Marzo S, Dav\u0026oacute;-Cabrera JM, Pi\u0026aacute;-Lude\u0026ntilde;a JV. Transscleral versus endoscopic cyclophotocoagulation outcomes for refractory glaucoma. Eur J Ophthalmol. 2021;31 (3):1107-1112. \u003c/li\u003e\n\u003cli\u003eRuixue W, Tao W, Ning L. A comparative study between ultrasound cycloplasty and cyclocryotherapy for the treatment of neovascular glaucoma. J Ophthalmol. 2020;2020:4016536. \u003c/li\u003e\n\u003cli\u003eCao H, Xu Z, Long H, et al. Trans-catheter arterial chemoembolization in combination with high-intensity focused ultrasound for unresectable hepatocellular carcinoma: a systematic review and meta-analysis of the Chinese literature. Ultrasound Med Biol 2011; 3 (7): 1009\u0026ndash;1016. \u003c/li\u003e\n\u003cli\u003eMastopasqua R, Agnifili L, Fasanella V, et al. Uveo-scleral outflow pathways after ultrasonic cyclocoagulation in refractory glaucoma: an anterior segment optical coherence tomography and in vivo confocal study. Br J Ophthalmol 2016; 100 (12): 1668\u0026ndash;1675. \u003c/li\u003e\n\u003cli\u003eMorais Sarmento T, Figueiredo R, Garrido J, Passos I, Rebelo AL, Candeias A. Ultrasonic circular cyclocoagulation prospective safety and effectiveness study. Int Ophthalmol. 2021;41 (9):3047-3055. \u003c/li\u003e\n\u003cli\u003eFan FF, Ge X, Liu DD, Xu TY, Wang RX, Chen XY, Li SY. Comparison of the efficacy and safety of ultrasonic cycloplasty vs valve implantation and anti-VEGF for the treatment of fundus disease-related neovascular glaucoma. Int J Ophthalmol. 2023 Jun 18;16(6):897-903. doi: 10.18240/ijo.2023.06.10. PMID: 37332547; PMCID: PMC10250935.\u003c/li\u003e\n\u003cli\u003eBielewicz J, Daniluk B, Kamieniak P. VAS and NRS, Same or Different? Are Visual Analog Scale Values and Numerical Rating Scale Equally Viable Tools for Assessing Patients after Microdiscectomy? Pain Res Manag. 2022 Mar 29;2022:5337483. doi: 10.1155/2022/5337483. PMID: 35391853; PMCID: PMC8983264.\u003c/li\u003e\n\u003cli\u003eAlmobarak FA, Alrubean A, Alsarhani WK, Aljenaidel A, Osman EA. Outcomes of Ultrasound Cyclo Plasty in Primary Angle Closure Glaucoma. J Glaucoma. 2023 May 1;32(5):407-413. doi: 10.1097/IJG.0000000000002182. Epub 2023 Feb 3. PMID: 36795514.\u003c/li\u003e\n\u003cli\u003eFigus M, Palma A, Covello G, Agnifili L, Posarelli C. Ultrasound Cyclo Plasty in Patients with Open Angle Glaucoma and High Myopia. J Glaucoma. 2023 May 1;32(5):420-425. doi: 10.1097/IJG.0000000000002185. Epub 2023 Feb 10. PMID: 36795513.\u003c/li\u003e\n\u003cli\u003eChen, D. , Guo, XJ. , Luo, SK. et al. Efficacy and safety of high-intensity focused ultrasound cyclo-plasty in glaucoma. BMC Ophthalmol 2022; 22, 401. \u003c/li\u003e\n\u003cli\u003eBras D, Maggio F. Surgical treatment of canine Glaucoma: Cyclodestructive techniques. Vet Clin North Am Small Anim Pract. 2015;45(6):1283\u0026ndash;305.\u003c/li\u003e\n\u003cli\u003eHuang XT, Qi Y, Cui QQ, Zan XN, Wang YR, Feng-Yan Zhang. Clinical effect and safety of ultrasound cyclo - plasty in the treatment of neovascular glaucoma. Int Eye Sci, 2020;20 (5):842-846. \u003c/li\u003e\n\u003cli\u003eDe Gregorio, A., Pedrotti, E., Stevan, G. \u003cem\u003eet al. \u003c/em\u003eSafety and efficacy of multiple cyclocoagulation of ciliary bodies by high-intensity focused ultrasound in patients with glaucoma. Graefes Arch Clin Exp Ophthalmol 2017;255, 2429\u0026ndash;2435. \u003c/li\u003e\n\u003cli\u003eDeb-Joardar N, Reddy KP. Application of high intensity focused ultrasound for treatment of open-angle glaucoma in Indian patients. Indian J Ophthalmol 2018; 66(4): 517\u0026ndash;523. \u003c/li\u003e\n\u003cli\u003eBolek B, Wylęgała A, Wylęgała E. Assessment of scleral and conjunctival thickness of the eye after ultrasound ciliary plasty. J Ophthalmol. 2020;24;2020:9659014.\u003c/li\u003e\n\u003cli\u003eZhou LF, Hu Die,Lan Jie, et al. Efficacy and safety of single Ultrasound Cyclo-Plasty to treat refractory glaucoma: Results at 1\u0026thinsp;year. Eur J Ophthalmol. 2022 Jan;32(1):268-274. doi: 10.1177/1120672120973605. Epub 2020 Nov 22. PMID: 33225725.\u003c/li\u003e\n\u003cli\u003eMastropasqua R, Agnifili L, Fasanella V, Toto L, Brescia L, Di Staso S, Doronzo E, Marchini G. Uveo-scleral outflow pathways after ultrasonic cyclocoagulation in refractory glaucoma: an anterior segment optical coherence tomography and in vivo confocal study. Br J Ophthalmol. 2016 Dec;100(12):1668-1675. doi: 10.1136/bjophthalmol-2015-308069. Epub 2016 Feb 16. PMID: 26883868. \u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eAnterior flat and steep keratometry 1 day, 1 month, and 6 months after UCP treatment\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eTime\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eN\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eanterior flat keratometry\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003et\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eP\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eanterior steep keratometry\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003et\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eP\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBaseline\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e23\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e43.74\u0026thinsp;\u0026plusmn;\u0026thinsp;2.18\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e-\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e-\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e45.06\u0026thinsp;\u0026plusmn;\u0026thinsp;1.44\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e-\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e-\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDay-1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e23\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e43.32\u0026thinsp;\u0026plusmn;\u0026thinsp;2.05\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3.657\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.001*\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e44.69\u0026thinsp;\u0026plusmn;\u0026thinsp;1.35\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2.468\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.022*\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMonth-1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e17\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e43.45\u0026thinsp;\u0026plusmn;\u0026thinsp;2.29\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1.548\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.137\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e45.02\u0026thinsp;\u0026plusmn;\u0026thinsp;1.44\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e-0.298\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.769\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMonth-6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e16\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e43.35\u0026thinsp;\u0026plusmn;\u0026thinsp;2.20\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1.436\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.167\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e45.22\u0026thinsp;\u0026plusmn;\u0026thinsp;1.69\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e-1.636\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.118\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eF\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.173\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.495\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eP\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.915\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.687\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003ctfoot\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"8\"\u003e* The difference is statistically significant.\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"8\"\u003ePaired t-test was used to compare single group data with preoperative data,and ANOVA test was used to compare whether the means of multiple samples were significantly different.\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tfoot\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eIntra-operative and postoperative complications.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eDescription\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eNumber of eyes (%)\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eIntraoperative\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePain\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e5(21.74)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003ePost-operative\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eScleral imprint\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e12(52.17)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eConjunctival hyperemia\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e11(47.83)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAnterior chamber inflammation\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1(4.35)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHyphema\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1(4.35)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\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":"Ultrasound cycloplasty, Intraocular pressure, Complication, Anterior segment structure, Glaucoma","lastPublishedDoi":"10.21203/rs.3.rs-4113871/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4113871/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjectives\u003c/h2\u003e \u003cp\u003eTo explore effects of ultrasound cycloplasty (UCP) in glaucoma patients, aiming to evaluate the efficacy and safety of UCP.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eTwenty-two glaucoma patients (23 eyes) who received UCP treatment at the Ophthalmology Department of Nanchang First Hospital from July 2020 to September 2022 were selected.Intraocular pressure (IOP), number of anti-glaucoma agents, best corrected visual acuity (BCVA) and eye pain scores of the patients before and 1, 3, 7 days, 1, 3 and 6 months after treatment were recorded.The complications during treatment and after treatment were also observed.The corneal curvature, pupil size, corneal thickness and anterior chamber depth of pentacam before and 1 day, 1 and 6 months after treatment were measured.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe preoperative IOP, number of anti-glaucoma agents, and eye pain scores were 37.35\u0026thinsp;\u0026plusmn;\u0026thinsp;13.79 mmHg, average 3.35\u0026thinsp;\u0026plusmn;\u0026thinsp;1.23 and 4.39\u0026thinsp;\u0026plusmn;\u0026thinsp;2.15, which were decreased significantly at each time point after UCP treatment (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0. 01). The IOP decrease rates were 33.31%, 45.68%, 46.32%, 47.23%, 41.93%, and 48.46%, respectively. The postoperative IOP reduction at 1, 3 and 7 days, 1, 3 and 6 months were significantly correlated with preoperative IOP (\u003cem\u003er\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.719, 0.750, 0.797, 0.661,0.515 and 0.607, all \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). No serious complication was observed throughout the treatment and the follow-up.There was a temporary change in anterior keratometry 1 day after UCP treatment. BCVA, pupil diameter, corneal thickness and anterior chamber depth remained unchanged.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eUCP was demonstrated to be effective in decreasing IOP, IOP-lowering medications and pain scores in patients with glaucoma. 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