Comparison of the Success Rate of a Procedure With Peeling of Limiting the Intern of the Retina Versus a Traditional Procedure Without Peeling of Limiting, at Patients Presenting a Macular Hole.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups
研究概览
简要总结
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study.
Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at third postoperative month is higher in the ILM peeling group.
Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient.
Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI.
Awaited results: To show that the success rate of the surgery of idiopathic macular holes larger than 400 µm is improved by ILM peeling. This category could then have a success rate similar to the small holes. If this difference is not proven, it will remain no justification to continue this procedure which represents little risk but which is not either without consequence.
详细描述
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study.
Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at three postoperative months is higher in the ILM peeling group.
Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient.
Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI.
Secondary objectives: - Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI. - Gain of ETDRS visual acuity in the third postoperative month.- Progression of cataract - Frequency of the complications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or higher than 18 years
- •Patient presenting a TM idiopathic of stage 2, 3 or 4
- •Macular hole > 400 µm in diameter
- •Patient having been informed of the objectives and constraints of the study and having signed an informed consent
排除标准
- •Patient age < 18 years.
- •Patient having a strong myopia of the operated eye: correction carried or optimal >6 dioptres
- •Patient MONOPHTHALMIA.
- •Patient pseudophakia presenting an "insufficient" plan capsular CRYTALLINE.
- •Patient presenting a cataract making impossible a good visualization of the bottom of eye.
- •Patient presenting an important opacification capsular.
- •Patient presenting an associated ocular pathology being able to interfere with the operation.
- •Patient presenting a TM already operated of the eye to include
结局指标
主要结局
percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups
时间窗: at 3 months
次要结局
- Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI.(at 3 months)
- Gain of ETDRS visual acuity in the third postoperative month(at 3 months)
- Progression of cataract(at 3 months)
- Frequency of the complications.(at 3 months)