Yong Min Lee, Bobak Bahrami, Duleepa Baranage, Premala Devi Sivagurunathan, Wilson Wong, Montserrat Maria Bausili, Surbhi Agrawal, Jagjit Singh Gilhotra, Shane Durkin, David Sia, Dinesh Selva, Stewart Lake, Robert J Casson, Weng Onn Chan
{"title":"外用多佐胺治疗黄斑孔:随机、双盲、安慰剂对照试验。","authors":"Yong Min Lee, Bobak Bahrami, Duleepa Baranage, Premala Devi Sivagurunathan, Wilson Wong, Montserrat Maria Bausili, Surbhi Agrawal, Jagjit Singh Gilhotra, Shane Durkin, David Sia, Dinesh Selva, Stewart Lake, Robert J Casson, Weng Onn Chan","doi":"10.1111/ceo.14432","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>To assess topical dorzolamide as medical therapy for idiopathic full-thickness macular holes (FTMHs).</p><p><strong>Methods: </strong>Randomised, double-blinded, placebo-controlled, single-centre clinical trial involving 32 patients with idiopathic small FTMHs (<400 <math><mrow><mi>μm</mi></mrow> </math> ). Participants in both arms used topical dorzolamide 2% or saline thrice daily for 8 weeks with monthly OCT. Those with persisting FTMH underwent vitrectomy with ILM peel and gas tamponade. The primary outcome was the rate of FTMH closure at the end of treatment.</p><p><strong>Results: </strong>Between 6 March 2020 and 16 June 2023, 32 eligible patients were enrolled: 16 participants in each arm. All participants in both groups were included in the final analysis. At the final visit, 3 of 16 (18.8%) patients in both the topical dorzolamide and placebo group demonstrated closure. There was no statistically significant difference in the proportion of FTMH closure between the control and treatment group (p = 1.00), nor statistically significant difference in the mean change in best corrected visual acuity (BCVA; p = 0.909). There was no difference in the change in FTMH diameter between groups (p = 0.225). No serious adverse events were reported in either group.</p><p><strong>Conclusion: </strong>Topical dorzolamide was safe but not superior to placebo in the functional and anatomical outcomes of FTMH.</p>","PeriodicalId":55253,"journal":{"name":"Clinical and Experimental Ophthalmology","volume":null,"pages":null},"PeriodicalIF":4.9000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Topical dorzolamide for macular holes: A randomised, double-blind, placebo-controlled trial.\",\"authors\":\"Yong Min Lee, Bobak Bahrami, Duleepa Baranage, Premala Devi Sivagurunathan, Wilson Wong, Montserrat Maria Bausili, Surbhi Agrawal, Jagjit Singh Gilhotra, Shane Durkin, David Sia, Dinesh Selva, Stewart Lake, Robert J Casson, Weng Onn Chan\",\"doi\":\"10.1111/ceo.14432\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>To assess topical dorzolamide as medical therapy for idiopathic full-thickness macular holes (FTMHs).</p><p><strong>Methods: </strong>Randomised, double-blinded, placebo-controlled, single-centre clinical trial involving 32 patients with idiopathic small FTMHs (<400 <math><mrow><mi>μm</mi></mrow> </math> ). Participants in both arms used topical dorzolamide 2% or saline thrice daily for 8 weeks with monthly OCT. Those with persisting FTMH underwent vitrectomy with ILM peel and gas tamponade. The primary outcome was the rate of FTMH closure at the end of treatment.</p><p><strong>Results: </strong>Between 6 March 2020 and 16 June 2023, 32 eligible patients were enrolled: 16 participants in each arm. All participants in both groups were included in the final analysis. At the final visit, 3 of 16 (18.8%) patients in both the topical dorzolamide and placebo group demonstrated closure. There was no statistically significant difference in the proportion of FTMH closure between the control and treatment group (p = 1.00), nor statistically significant difference in the mean change in best corrected visual acuity (BCVA; p = 0.909). There was no difference in the change in FTMH diameter between groups (p = 0.225). No serious adverse events were reported in either group.</p><p><strong>Conclusion: </strong>Topical dorzolamide was safe but not superior to placebo in the functional and anatomical outcomes of FTMH.</p>\",\"PeriodicalId\":55253,\"journal\":{\"name\":\"Clinical and Experimental Ophthalmology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.9000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Experimental Ophthalmology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/ceo.14432\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/15 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Experimental Ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/ceo.14432","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/15 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
Topical dorzolamide for macular holes: A randomised, double-blind, placebo-controlled trial.
Background: To assess topical dorzolamide as medical therapy for idiopathic full-thickness macular holes (FTMHs).
Methods: Randomised, double-blinded, placebo-controlled, single-centre clinical trial involving 32 patients with idiopathic small FTMHs (<400 ). Participants in both arms used topical dorzolamide 2% or saline thrice daily for 8 weeks with monthly OCT. Those with persisting FTMH underwent vitrectomy with ILM peel and gas tamponade. The primary outcome was the rate of FTMH closure at the end of treatment.
Results: Between 6 March 2020 and 16 June 2023, 32 eligible patients were enrolled: 16 participants in each arm. All participants in both groups were included in the final analysis. At the final visit, 3 of 16 (18.8%) patients in both the topical dorzolamide and placebo group demonstrated closure. There was no statistically significant difference in the proportion of FTMH closure between the control and treatment group (p = 1.00), nor statistically significant difference in the mean change in best corrected visual acuity (BCVA; p = 0.909). There was no difference in the change in FTMH diameter between groups (p = 0.225). No serious adverse events were reported in either group.
Conclusion: Topical dorzolamide was safe but not superior to placebo in the functional and anatomical outcomes of FTMH.
期刊介绍:
Clinical & Experimental Ophthalmology is the official journal of The Royal Australian and New Zealand College of Ophthalmologists. The journal publishes peer-reviewed original research and reviews dealing with all aspects of clinical practice and research which are international in scope and application. CEO recognises the importance of collaborative research and welcomes papers that have a direct influence on ophthalmic practice but are not unique to ophthalmology.