Macular Peeling With Foveal Sparing of the Internal Limiting Membrane: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 主要终点
- Retinal Sensitivity (dB)
研究概览
简要总结
To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or 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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provision of written informed consent
- •age > 60 years
- •presence of idiopathic macular pucker or macular hole documented by OCT
排除标准
- •any prior intraocular surgery
- •pathologic myopia (> 7 diopters)
- •age related macular degeneration
- •glaucoma and diabetic retinopathy or any other retinal vascular disease
研究组 & 干预措施
Complete Peeling
Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with complete macular peeling of the internal limiting membrane.
干预措施: Complete Macular Peeling (Procedure)
Foveal Sparing
Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with partial peeling the internal limiting membrane (foveal sparing).
干预措施: Macular Peeling with Foveal Sparing (Procedure)
结局指标
主要结局
Retinal Sensitivity (dB)
时间窗: 12-month
Microperimetry was done to assess macular sensitivity
Visual Acuity (LogMAR)
时间窗: 12-month
ETDRS charts were used to assess best corrected visual acuity
Central Retinal Thickness (microns)
时间窗: 12-month
Optical Coherence Tomography will be used to assess central retinal thickness
次要结局
未报告次要终点
研究者
Francesco Semeraro
Francesco Semeraro; MD, Associate Professor
Università degli Studi di Brescia