Observational Prospective Monocentric Study Evaluating "Sweeper" Use During Epiretinal Membrane Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Difference of number and depth of micro scotoma before and after epiretinal membrane (ERM) surgery with sweeper
研究概览
简要总结
Epiretinal membrane (ERM) is a pathological phenomenon requiring surgery when vision is altered.
ERM surgery requires ERM peeling, then active internal limiting membrane (ILM) peeling if it is not spontaneously peeled with ERM. Initiation of peeling is very delicate and can lead to micro scotoma when realized with microscopic forceps. The Sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. It may reduce retinal trauma and visual sequelae.
Purpose of our study is to evaluate use of sweeper during 20 ERM surgeries. The investigator will compare microperimetry before surgery versus those after 1 month (M1) and 3 months (M3), and measure difference of number and depths of micro scotoma.
The investigator will note: number of forceps uses if sweeper is inefficient and all areas of sweeper use to correlate them with micro scotoma.
The investigator will evaluate visual and optical coherence tomography improvement after surgery.
详细描述
Epiretinal membrane (ERM) is a pathological phenomenon that leads to visual loss, visual distortions, central scotoma, and diplopia. No medical treatment is yet available.
ERM surgery requires separation of normal retina and epiretinal membrane. After epiretinal peeling, if internal limiting membrane (ILM) is not spontaneously peeled with ERM, surgeon peels ILM from retina (also named active peeling). Initiation of peeling is very accurate and delicate. Either microscopic forceps or sweeper are used to initiate peeling. Sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. It may reduce retinal trauma and visual sequelae.
ILM active peeling reduces recurrence of ERM and rate of repeat surgery. No visual acuity loss has been found. But 2 studies show increase of micro scotoma at micro-perimetry after active ILM peeling with forceps.
Purpose of our study is to evaluate use of sweeper during 20 ERM surgeries. The investigator will compare microperimetry before surgery versus those after 1 month (M1) and 3 months (M3), and measure difference of number and depths of micro scotoma.
The investigator will note: number of forceps uses if sweeper is inefficient, all areas of sweeper use to correlate them with micro scotoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •adult patient,
- •Epiretinal membrane
排除标准
- •perimetry impossible
结局指标
主要结局
Difference of number and depth of micro scotoma before and after epiretinal membrane (ERM) surgery with sweeper
时间窗: microperimetry at baseline, then 1 month after surgery (M1), then 3 months after (M3)
次要结局
- Efficacy of sweeper mesured by number of forceps uses if sweeper is inefficient(Day of surgery)
- Visual improvement measured by visual acuity and optical coherence tomography improvement after surgery , visual acuity and OCT morphometry before surgery, M1 and M3(at baseline, then 1 month after surgery (M1), then 3 months after (M3))
- Optical coherence tomography (OCT) improvement after surgery measured by OCT morphometry(at baseline, then 1 month after surgery (M1), then 3 months after (M3))