Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Mean change from baseline in best-corrected visual acuity (BCVA)
研究概览
简要总结
Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clear diagnosis of macular hole;
- •The minimum diameter of the macular hole is >400 μm;
- •Without serious systemic disease that make patients can not be operated;
排除标准
- •suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;
- •opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;
- •eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;
- •traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;
- •having a history of vitrectomy surgery;
- •glaucoma in stage of preclinical, severe stenosis or closure;
研究组 & 干预措施
Large extent of ILM Peeling
Extent of ILM peeling is 4DD and the ILM flap is inserted
干预措施: Large extent of ILM Peeling (Procedure)
Small extent of ILM Peeling
Extent of ILM peeling is 2DD and the ILM flap is inserted
干预措施: Small extent of ILM Peeling (Procedure)
结局指标
主要结局
Mean change from baseline in best-corrected visual acuity (BCVA)
时间窗: 1 year
Assessed using the ETDRS protocol
change from baseline in foveal avascular zone (FAZ) areas and diameter
时间窗: 1 year
Assessed on AngioOCT
change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels
时间窗: 1 year
Assessed on AngioOCT
Condition of postoperative healing of macular holes
时间窗: 1 year
postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)
次要结局
未报告次要终点
研究者
Xiangtian Zhou
Professor
Wenzhou Medical University