Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Retinal reattachment rate
研究概览
简要总结
Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD treatment
详细描述
The study takes place in the S.N. Fyodorov "Eye Microsurgery" Federal State Institution located in Moscow, Russian Federation.
The study will include 50 patients with rhegmatogenous retinal detachment due to a horseshoe-tear. In addition to the standard ophthalmological examination, all patients will undergo wide-field optical coherence tomography to determine the extension and localization of the vitreoretinal traction zone. The obtained data will be used to planning the 1st step of laser-surgical treatment. All patients will undergo a combined laser-surgical technology, which includes 3 steps: 1) Nd-YAG laser excision of the vitreoretinal traction zone 2) pneumatic retinopexy (10% C3F8) 3) barrier laser photocoagulation around retinal break after retinal attachment.
The patients are going to be followed up for at least 1 year, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rhegmatogenous retinal detachment extending from the 9-o'clock to the 3-o'clock meridians.
- •Superior retinal break from 9 o'clock to 3 o'clock
- •Single retinal break not greater than 1 clock hours in size
- •Physically and mentally co-operated in post-operative head positioning
- •No (or minimal) proliferative vitreoretinopathy
- •None or mild vitreous hemorrhage.
排除标准
- •Severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR
- •Ocular media opacities
- •Previous ocular surgeries
- •Age <18 years
- •Previous retinal detachment (index eye)
研究组 & 干预措施
Combined laser-surgical technology
Combined laser-surgical technology includes 3 steps:
- Nd-YAG laser excision of the vitreoretinal traction zone
- Pneumatic retinopexy (10% C3F8)
- Barrier laser photocoagulation around retinal break after retinal attachment.
干预措施: Combined laser-surgical technology of RRD treatment (Procedure)
结局指标
主要结局
Retinal reattachment rate
时间窗: in 1 month after gas resorption
complete retinal re-attachment
次要结局
- Visual acuity(3, 6, 12 and 24 months post intervention)
- Anatomical success(3, 6, 12 and 24 months post intervention)
研究者
Taevere M.R
Principal Investigator
The S.N. Fyodorov Eye Microsurgery State Institution