跳至主要内容
临床试验/NCT04278079
NCT04278079已完成不适用

Evaluation of Pars Plana Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

Tanta University0 个研究点目标入组 52 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
主要终点
Improvement of best corrected visual acuity

研究概览

简要总结

Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy

详细描述

Performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is the standard of care for patients with myopic traction. A variety of findings are seen by Optical Coherence Tomography. Epiretinal membranes, retinoschisis, lamellar macular holes, and full thickness macular holes are seen. Undergoing vitrectomy, with or without tamponade, in our center, is retrospectively evaluated. Visual acuity change, as well as improvement of the retinal structure by OCT will be examined.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 Diopter, or an axial length more than 26.5 mm.
  • Best Corrected Visual Acuity less than 0.1
  • Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane
  • At least 6 months follow-up

排除标准

  • Eyes with diffuse chorioretinal macular atrophy
  • Concomitant presence of a choroidal neovascular membrane
  • Young patients less than 21 years old.
  • History of trauma
  • Dense media opacity (corneal/ lenticular)

结局指标

主要结局

Improvement of best corrected visual acuity

时间窗: 6 months

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

Sharif Yousef El Emam

Clinical Associate Professor

Tanta University

相似试验