Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- epiretinal membrane
研究概览
简要总结
Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.
The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.
In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.
详细描述
interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 73 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).
排除标准
- •Complicated cases with advanced proliferative vitreoretinopathy (PVR).
- •Patients with retinal vascular disorders and other macular disorders.
- •Combined tractional and rhegmatogenous detachment.
- •Previous retinal reattachment surgery or Intravitreal injections.
- •Glaucomatous patients.
- •Patients with corneal opacity which impairs good visualization.
研究组 & 干预措施
non-ILM peeling group
vitrectomy without ILM peeling is done to all cases
干预措施: Pars Plana Vitrectomy (Other)
ILM peeling group
vitrectomy with ILM peeling is done to all cases
干预措施: Pars Plana Vitrectomy (Other)
结局指标
主要结局
epiretinal membrane
时间窗: 6 months follow up
incidence rate of epiretinal membrane formation after surgery in % percent
anatomical outcome
时间窗: 6 months follow up
Rate of retinal reattachment using indirect ophthalmoscopy
次要结局
- multi-focal Electroretinogram(6 months follow up)
- functional outcome(6 months follow up)
- superficial capillary density(6 months follow up)
研究者
Hossam Mohamed Moharram
Assistant professor of ophthalmology
Minia University