Impact of ILM Peeling on Functional and Anatomic Outcomes of Vitrectomy for Primary Rhegmatogenous Retinal Detachment - the I-Peel Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Number of patients developing secondary epiretinal membrane formation
研究概览
简要总结
Retinal detachment is associated with a substantial risk of re-detachment in 10-20% and to the formation of secondary epiretinal membranes in up to 15%. Relevant postoperative vision loss is encountered in many instances, primarily in consequence of macular involvement, but also secondarily due to postoperative complications, namely the formation of an epiretinal membrane and proliferative vitreoretinopathy. These mechanical reasons of influence can potentially be prevented by ILM peeling during reattachment surgery. This, however, is not a generally accepted standard of care during primary routine vitrectomy.
Two groups suffering from primary retinal detachment will be compared: the first group will receive standard re-attachment vitrectomy surgery, whereas the second group will receive an identical vitrectomy surgery, but with additional ILM peeling. In this study, the investigators wish to assess the influence of ILM peeling on visual outcomes and postoperative complications over 12 months.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary rhegmatogenous retinal detachment
- •of legal age (18 years or older)
- •in case of bilateral retinal detachment, only the first-affected eye will be included
排除标准
- •pre-existing functional and morphological changes to the macula, hindering visual recovery (amblyopia, trauma, macular degeneration)
- •advanced retinal detachment with PVR stage C2 or more
- •eyes pre-operated within six months prior to the development of RD
- •state after any vitreoretinal surgery
- •state after complicated cataract surgery, including aphakia and anterior chamber lens implantation
- •patients with increased risk profiles
- •myopia magna (≥7 diopters)
- •advanced diabetic retinopathy
- •any chronic ocular or systemic inflammatory disease
- •any other proliferative systemic disease or condition associated with impaired wound healing
结局指标
主要结局
Number of patients developing secondary epiretinal membrane formation
时间窗: 12 months
Clinically significant secondary epiretinal membrane formation requiring revision surgery
次要结局
- Complication rates(12 months)
- Surgical times(minutes (0-300))
- Rate of re-detachments in patients(12 months)
- Best-corrected visual acuity(12 months)