Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Tractional Retinal Detachment: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rush Eye Associates
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Postoperative ERM Development
Study Overview
Brief Summary
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
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
Study Group
Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment
Intervention: ILM Peeling (Procedure)
Control Group
Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment
Intervention: No ILM Peeling (Procedure)
Outcomes
Primary Outcomes
Postoperative ERM Development
Time Frame: 6 months
Postoperative Epiretinal Membrane Development
Secondary Outcomes
- Visual Acuity(6 months)
Investigators
Sloan W. Rush, MD
Physician
Rush Eye Associates