Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Retinopathy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
Hypothesis: Subjects undergoing ILM peeling during vitrectomy will have lower central macular thickness on OCT and lower rates of DME, fewer postoperative epiretinal membranes, and thereby better final visual acuity to control subjects Randomization: Subjects will be randomized according to a coin t...
Hypothesis: Subjects undergoing ILM peeling during vitrectomy will have lower central macular thickness on OCT and lower rates of DME, 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.
Tracking Information
- NCT #
- NCT04380064
- Collaborators
- Not Provided
- Investigators
- Not Provided
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