Pre-Operative Versus Post-Operative Intravitreal Aflibercept Injection for Management of DME in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- resolving of macular edema
研究概览
简要总结
To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF).
详细描述
A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three pre-operative intravitreal Aflibercept injections with a monthly interval, the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. follow up for 6 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients with visually significant cataract
排除标准
- •previous vitreoretinal surgery
- •laser or intravitreal injections 6 months prior to the procedure
- •intractable glaucom
- •active intra-ocular inflammation
- •retinal detachment
- •vitreous hemorrhage
- •epi-retinal membranes
- •any other retinal vascular or neuroretinal disease.
- •Patients with eventual cataract surgeries
结局指标
主要结局
resolving of macular edema
时间窗: Sixth month
change in central macular thickness
次要结局
- Improvement of visual acuity(Sixth month)
研究者
Abeer MohamedSadeck Khattab
consultant of ophthalmology
Al Hadi Hospital