Diabetic Retinopathy Visually Threatening Clinical Trial
Official title:
Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Tractional Retinal Detachment: a Randomized Clinical Trial
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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT03665090 -
Shanghai Cohort Study of Diabetic Eye Disease
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