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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
ILM peeling performed during primary PPV for PDR
ILM peeling not performed during primary PPV for PDR
Hospital La Carlota
Montemorelos, Nuevo León, Mexico
Postoperative ERM Development
Postoperative Epiretinal Membrane Development
Time frame: 6 months
Visual Acuity
Rate of subjects achieving 20/50 or better Snellen visual acuity
Time frame: 6 months
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