A Prospective Multicenter Study of Different Surgical Methods for the Treatment of Macular Schisis in High Myopia Based on the Real World
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- retinal thickness of the most significant schisis
研究概览
简要总结
In view of the current problem of treating high myopic macular schisis, the main purpose of our study is to find out the most appropriate time of surgical intervention, to compare the effectiveness and safety of various surgical methods in the treatment of high myopic macular schisis, and to find out the advantages and disadvantages of each surgical method in the treatment of MF. As well as the outcomes and complications of long-term follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •diopter ≤-6.00D or axial length ≥ 26.00mm;
- •OCT showed macular schisis with or without macular retinal detachment;
- •agreed to participate in this project and signed informed consent form.
排除标准
- •OCT confirmed full-thickness macular hole with or without macular retinal detachment；
- •submacular active or inactive CNV;
- •previous vitreoretinal surgery and anti-glaucoma surgery；
- •with rhegmatogenous retinal detachment, ocular trauma, glaucoma, corneal opacity and other ophthalmic diseases;
- •complicated with severe systemic disease can not tolerate surgery or follow-up;
- •do not agree to participate the project or disagree with the follow-up.
研究组 & 干预措施
PPV+ILM+/-Cat+/-Gas
干预措施: PPV+ILM+/-Cat+/-Gas (Procedure)
PPV+ILM+/-Cat+/-Oil
干预措施: PPV+ILM+/-Cat+/-Oil (Procedure)
PSR
干预措施: PSR (Procedure)
Gas
干预措施: Gas (Procedure)
Control
PPV+/-Cat
干预措施: PPV+/-Cat (Procedure)
PPV+/-Cat+Gas
干预措施: PPV+/-Cat+Gas (Procedure)
PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）
干预措施: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas） (Procedure)
结局指标
主要结局
retinal thickness of the most significant schisis
时间窗: change from baseline at 3, 6, 9, 12 months
measured by OCT
foveal thickness
时间窗: change from baseline foveal thickness at 3, 6, 9, 12 months
measured by OCT
次要结局
- Visual quality questionnaire(change from baseline at 3, 6, 9, 12 months)
- axial length(change from baseline at 3, 6, 9, 12 months)
- best corrected visual acuity(change from baseline at 3, 6, 9, 12 months)
- mf-ERG(change from baseline at 3, 6, 9, 12 months)