Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Tractional Retinal Detachment: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative ERM Development
研究概览
简要总结
Subject/Participant Groups:
Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment
详细描述
Hypothesis
Subjects undergoing ILM peeling during vitrectomy will have lower central macular thickness on OCT, fewer postoperative epiretinal membranes, and thereby better final visual acuity to control subjects Randomization: Subjects will be randomized according to a coin toss during PPV, once Grade 2 or Grade 3 vitreoretinal adhesion has been determined: heads undergo ILM peeling, while tails do not.
Number of Subjects: With study power of 80%, a significance level of 0.05, a sample size of 60 patients for each group was calculated.
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
- Single (Participant)
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
- •Subject age is 18-85 years.
- •Subject consents to study participation and is capable of 6 months of follow-up.
- •The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
- •Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
- •The subject is determined to need a PPV for the indication of TRD (Grades 2 and 3).
排除标准
- •Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
- •Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye.
- •Subject has a significant corneal or cataract opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
- •Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
- •Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
- •Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
研究组 & 干预措施
Study Group
Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment
干预措施: ILM Peeling (Procedure)
Control Group
Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment
干预措施: No ILM Peeling (Procedure)
结局指标
主要结局
Postoperative ERM Development
时间窗: 6 months
Postoperative Epiretinal Membrane Development
次要结局
- Visual Acuity(6 months)
研究者
Sloan W. Rush, MD
Physician
Rush Eye Associates