Evaluation of Vitrectomy With Planned Foveal Detachment as Surgical Treatment for Refractory Diabetic Macular Edema With or Without Vitreo-macular Interface Abnormality
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 28
- 主要终点
- central macular thickness decrease
研究概览
简要总结
To evaluate the therapeutic efficacy of sub retinal BSS injections in conjunction with conventional vitrectomy for refractory Diabetic macular edema (DME)- resistant to more than one anti-VEGF agent, intravitreal corticosteroids and to previous vitrectomy. Some of enrolled cases had normal vitreo-macular interface (VMI) relationship, while other cases had incomplete vitreoretinal separation with vitreomacular attachment (VMA).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases with refractory DME with a central macular thickness (CMT) of more than 300 µm despite undergoing anti-VEGF therapy (5-6 monthly injections of ranibizumab (IVR) or bevacizumab (IVB) with shifting to aflibercept (IVA) for additional 3 injections).
排除标准
- •The major exclusion criteria were: (1) presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula; (2) presence of proliferative diabetic fibrovascular membranes threating or at the macula; (3) presence of diabetic optic atrophy; and (4) presence of neovascular glaucoma.
研究组 & 干预措施
included cases
vitrectomy done with planned foveal separation and followed for the result
干预措施: vitrectomy with planned foveal detachment (Procedure)
结局指标
主要结局
central macular thickness decrease
时间窗: 10 months postperative
decrease in central macular thickness by OCT
次要结局
未报告次要终点
研究者
ahmed M. Abdel hadi
Assistant professor of ophthalmology
Ministry of Health and Population, Egypt