外用多佐胺治疗黄斑孔:随机、双盲、安慰剂对照试验。

IF 4.9 2区 医学 Q1 OPHTHALMOLOGY Clinical and Experimental Ophthalmology Pub Date : 2024-11-01 Epub Date: 2024-08-15 DOI:10.1111/ceo.14432
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
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引用次数: 0

摘要

背景:评估外用多佐胺作为特发性全厚黄斑孔(FTMHs)的药物疗法:评估局部使用多佐胺作为特发性全厚黄斑孔(FTMHs)的药物疗法:随机、双盲、安慰剂对照、单中心临床试验,涉及32名特发性小黄斑孔(μm $ \upmu \mathrm{m} $$)患者。两组参与者均使用局部 2% 多佐胺或生理盐水,每天三次,持续 8 周,每月进行一次 OCT 检查。FTMH持续存在者接受玻璃体切除术,同时进行ILM剥离和气体填塞。主要结果是治疗结束时FTMH的闭合率:2020年3月6日至2023年6月16日,32名符合条件的患者入组:两组各 16 人。两组的所有参与者均纳入最终分析。在最终检查中,局部多佐胺组和安慰剂组的 16 名患者中均有 3 人(18.8%)出现闭合。对照组和治疗组的 FTMH 闭合比例差异无统计学意义(p = 1.00),最佳矫正视力(BCVA;p = 0.909)的平均变化差异也无统计学意义。治疗组和对照组的 FTMH 直径变化无差异(p = 0.225)。两组患者均未出现严重不良反应:结论:局部使用多佐胺是安全的,但在 FTMH 的功能和解剖结果方面并不优于安慰剂。
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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 μm ). 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.

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来源期刊
CiteScore
7.60
自引率
12.50%
发文量
150
审稿时长
4-8 weeks
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.
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