Comparison of Macular Hole Closure Rate in Patients With Poor Prognosis Clinical Features Treated With Amniotic Membrane Graft With and Without Limitorrhexis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- % of macular hole clousure measured with OCT
研究概览
简要总结
Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter > 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional outcome has not been found.
详细描述
Interventional study in large macular holes (diameter > 550 μm) using an amniotic membrane with and without internal limiting membrane peeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
We never let the patient know the performed surgery
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Not myopic patients (<6 Dioptre or <26 mm)
- •Large macular hole >550 μm
- •> 6 months symptoms
- •Signing informed consent
排除标准
- •Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc)
- •Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)
- •Patients with ocular surgery
结局指标
主要结局
% of macular hole clousure measured with OCT
时间窗: 6 months
Closure of the macular hole by optical coherence tomography
次要结局
- Superficial and deep retinal capillary plexus density with OCT-A(6 months)
- Best-corrected visual acuity measured with Snellen Chart(6 months)
研究者
Jose Luis Rodriguez Loaiza
Medical Subdirector
Instituto de Oftalmología Fundación Conde de Valenciana