Surgical Inverted ILM Repositioning as Autologous Dressing for Idiopathic Full Thickness Macular Holes Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Best-corrected visual acuity (BCVA), postoperative macular hole closure type
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of surgical treatment of FTMH using an inverted ILM repositioning to improve anatomical and functional outcomes in patients with a macular hole.
详细描述
At present, the anatomical closure rate of macular hole is around 90% using pars plana vitrectomy with ILM peeling. Improvement of visual acuity is around 80% including stage II to IV. With macular hole greater than 400 μm there is higher risk of surgical failure and visual acuity is usually less than 0.2. Large macular holes are more likely to have flat-open type closure, which is anatomical success but has limited improvement in visual acuity. Inverted ILM repositioning will form a scaffold for glial cells, which allows their migration and proliferation. This process will close the macular hole and secure it from re-opening, and will reduce the risk of flat-open type of closure.
The aim of this study is to estimate the efficiency and safety of inverted ILM repositioning in the treatment of macular hole with a minimum diameter exceeding 400 μm and compare results with the currently used methods of surgical large macular holes treatment.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •full-thickness macular hole with a minimum diameter exceeding 400 μm
- •BCVA of 0,3 or worse in log MAR units (<=70 ETDRS letter) and 1,6 or better in log MAR units (>=5 ETRDS letter)
- •18 years of age
- •Informed consent
排除标准
- •eyes with previous vitreous surgery
- •cystoid macular edema from any cause
- •post traumatic macular hole
- •macular hole associated with retinal detachment
- •any other ocular reason which causes the lack of improvement after macular hole surgery (e.g pigmentary abnormalities, age-related macular degeneration, corneal scarring)
结局指标
主要结局
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
时间窗: 48 weeks postoperatively ( plus or minus 1 week)
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
次要结局
- Central Macular Thickness (CMT), Central Macular Volume(48 weeks postoperatively (plus and minus 1 week))