跳至主要内容
临床试验/NCT05561569
NCT05561569招募中不适用

Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment

Benha University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Improvement in visual acuity

研究概览

简要总结

Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty.

详细描述

There is no single surgical plan for management of primary retinal detachment due to upper retinal break, some surgeons prefer scleral buckling over vitrectomy in cases with no traction over the retinal break, others prefer to perform primary pars-plana vitrectomy with either air or gas tamponade.

In this study we aim to compare the results of air and non-expansile gas tamponade in cases with upper retinal detachment with grade a or b proliferative vitreoretinopathy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.

排除标准

  • cases with combined tractional retinal detachment.
  • cases with recurrent retinal detachment.
  • cases that are eligible for scleral buckling that have no traction on retinal break.

结局指标

主要结局

Improvement in visual acuity

时间窗: Change from baseline visual acuity at 6th month.

Visual acuity changes measured by snellen chart and converted to LogMar units.

次要结局

  • Changes in metamorphopsia(Change from baseline metamorphopsia at 6th month.)

研究者

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

Ahmed Abdelshafy

Assistant professor of Ophthalmology

Benha University

研究点 (2)

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