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临床试验/NCT04288440
NCT04288440已完成不适用

Pathological Features of Epiretinal Membranes in Silicone Filled Eyes

Tanta University2 个研究点 分布在 1 个国家目标入组 31 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
31
试验地点
2
主要终点
Percentage of GFAP and CD cells in idiopathic and silicone oil ERM

研究概览

简要总结

31 patients were included in the study,15 cases with ERM in silicone filled eyes and 16 eyes with idiopathic ERM

详细描述

This is a prospective study that included 31 patients and was performed in Tanta University Eye Hospital in cooperation with the Pathology Department, Tanta University, between January 2018 and June 2019. The approval of the ethical committee of the Faculty of Medicine in Tanta University was obtained, and the study was conducted in accordance with the 1964 Helsinki Declaration and its later amendment. A detailed informed written consent was signed by all study participants. The research is not funded by the university or any organization or entity.

Fifteen cases had pars plana vitrectomy for rhegmatogenous retinal detachment nine months earlier with ERM detected by OCT one day before silicone oil removal. The other 16 cases matched for age and gender with idiopathic ERM and were included as a control. Histopathological features of the ERMs were compared between the two groups.

All patients have undergone complete ophthalmic evaluation including: best corrected visual acuity (BCVA) by Snellen chart that was converted to log MAR for statistical analysis, anterior segment examination by slit lamp, posterior segment examination by slit lamp bimicroscopy using +78 D lens and indirect Ophthalmoscopy, and Spectral domain optical coherence tomography (SD-OCT) (Spectralis; Heidelberg Engineering,Heidelberg, Germany) was performed for all patients before surgery.

The investigators excluded patients with previous intraocular surgery (except cataract surgery) for the control group, diabetes mellitus/diabetic retinopathy, coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration, previous laser photocoagulation, intravitreal injection of Triamcinolone Acetonide or antivascular endothelial growth factor (anti-VEGF) agents, prior intra-ocular inflammation, retinal degenerations, neovascularization or rubeosis and vascular disorders e.g. retinal vein or artery occlusion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
42 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Fifteen cases had pars plana vitrectomy for rhegmatogenous retinal detachment nine months earlier with ERM detected by OCT one day before silicone oil removal.
  • The other 16 cases matched for age and gender with idiopathic ERM and were included as a control. Histopathological features of the ERMs were compared between the two groups.

排除标准

  • the investigator excluded 1-patients with previous intraocular surgery (except cataract surgery) for the control group.
  • 2- Diabetes mellitus/diabetic retinopathy. 3-Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
  • 4-previous laser photocoagulation, intravitreal injection of Triamcinolone Acetonide or antivascular endothelial growth factor (anti-VEGF) agents.
  • 5- prior intra-ocular inflammation, retinal degenerations.
  • 6-Neovascularization or rubeosis and vascular disorders e.g. retinal vein or artery occlusion.

结局指标

主要结局

Percentage of GFAP and CD cells in idiopathic and silicone oil ERM

时间窗: 6 months

Percentage of glial fibrillary acid protein positive cells and number of cluster of differentiation cells in idiopathic and silicone oil ERM

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

Lecturer of Ophthalmology

Tanta University

研究点 (2)

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