跳至主要内容
临床试验/NCT03927430
NCT03927430已完成不适用

To Peel or Not to Peel: Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

Klinikum Chemnitz gGmbH1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
number of patients with CNV

研究概览

简要总结

Surgical outcome of patients with macular drusen and co-existing abnormalities of the vitreoretinal interface, who routinely undergo pars plana vitrectomy with membrane peeling, is evaluated. Best corrected visual acuity as well as optical coherence tomography data are compared at baseline and last follow up. The rate of development of choroidal neovascularization postoperatively is noted.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • participants diagnosed with ERM or FTMH and co-existing macular drusen;
  • undergone pars plana vitrectomy with ILM and epiretinale membrane peeling;
  • SD-OCT at the initial visit and at last follow up visit with image quality score >30;
  • no evidence of CNV on initial fluorescein angiography (FA).

排除标准

  • history of other macular disease, severe non-proliferative or proliferative diabetic retinopathy, other retinal vascular diseases, glaucoma, myopic retinopathy, or other diseases interfering with OCT images in any one of the eyes;
  • active CNV or history of CNV

结局指标

主要结局

number of patients with CNV

时间窗: last visit, in common 6 months postoperatively

number of patients with CNV (choroidal neovascularization) development

次要结局

  • incidence of central retinal atrophy(last visit, in common 6 months postoperatively)
  • BCVA(last visit, in common 6 months postoperatively)

研究者

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

Katrin Engelmann

Head of Ophthalmology

Klinikum Chemnitz gGmbH

研究点 (1)

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