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临床试验/NCT03618498
NCT03618498已完成不适用

Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment in Eyes of Proliferative Diabetic Retinopathy

Changhua Christian Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年3月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Wilcoxon Sign-Rank test

研究概览

简要总结

Purpose: To evaluate the logical surgical approaches in closing macular holes in eyes of proliferative diabetic retinopathy with retinal detachment

详细描述

High MH closure rate can be achieved. Other than high myopia, MH with RD may appear in several conditions, such as severe vitreomacular traction, proliferative diabetic retinopathy (PDR).clinical charts were reviewed of patients of proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.Standard 3-port 23 or 25 gauged pars plana vitrectomy was performed. After core vitrectomy, anterior-posterior oriented tractions as well as all fibrovascular tissues were removed as thoroughly as possible.The patients were kept in a facedown position overnight and were allowed to take any positions except supine for approximately one week.Various surgical approaches utilizing in managing macular hole may effectively closing macular holes and reattach retina.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients were proliferative diabetic retinopathy suffering from MH with RD.

排除标准

  • Patients were not proliferative diabetic retinopathy suffering from MH with RD.

研究组 & 干预措施

Patient accept surgery

Other

Proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.

干预措施: ILM flaps insertion techniques or free ILM flaps. (Procedure)

结局指标

主要结局

Wilcoxon Sign-Rank test

时间窗: Baseline, 12 months.

A statistical comparison of average of two dependent samples

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

San Ni Chen

medical doctor

Changhua Christian Hospital

研究点 (1)

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