Evaluation of Vitrectomy for Diabetic Macular Edema Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 47
- 主要终点
- Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline
研究概览
简要总结
The study is designed as a prospective cohort study to assess changes in visual acuity and retinal thickening and surgical complications in subjects undergoing vitrectomy for diabetic macular edema.
The study also aims to identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial and to obtain data that can be used to plan a randomized trial.
Subject will be followed through 2 years, with a primary outcome at 6 months post vitrectomy surgery. The vitrectomy procedure will be performed based on the investigators usual care and is not considered part of the research although the procedure performed will be collected.
详细描述
Study Design The study is designed as a prospective cohort study. A randomized trial design was considered but rejected after deciding that there was insufficient equipoise on the part of the investigator group to randomize eyes with DME and vitreal traction to surgery or no surgery (thus eyes which potentially may benefit most from vitrectomy would not be included), and there was insufficient information available on the natural course or surgical outcomes of eyes with DME but without significant traction.
A cohort study provides the opportunity to collect data prospectively using a standardized protocol to assess the potential benefits and risks of vitrectomy. The results can be used to determine whether proceeding with a randomized trial has merit and what the design of the trial should be. If a randomized trial is to be conducted, the results plus the cohort study experience can be used to help design the protocol.
Study Objectives
- To provide information on the following outcomes in eyes with Diabetic Macular Edema (DME) that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction (if present), surgical complications.
- To identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial.
- To obtain data that can be used to plan a randomized trial.
B. Intervention Vitrectomy performed by the investigator's usual routine.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline
时间窗: Baseline to 6 Months
Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.
Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months
时间窗: Baseline to 6 months
Change in thickness is followup thickness minus baseline thickness.
Visual Acuity
时间窗: Baseline to 6 months
Change in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Percent of Participants With Change in Visual Acuity From Baseline to Six Months
时间窗: Baseline to 6 months
次要结局
- Surgical Complications From Baseline to Six Months(Baseline to 6 months)