Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study Group Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment |
Procedure: ILM Peeling
ILM peeling performed during primary PPV for PDR
|
| Active Comparator: Control Group Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment |
Procedure: No ILM Peeling
ILM peeling not performed during primary PPV for PDR
|
Outcome Measures
Primary Outcome Measures
- Postoperative ERM Development [6 months]
Postoperative Epiretinal Membrane Development
Secondary Outcome Measures
- Visual Acuity [6 months]
Rate of subjects achieving 20/50 or better Snellen visual acuity
Eligibility Criteria
Criteria
Inclusion:
-
Subject age is 18-85 years.
-
Subject consents to study participation and is capable of 6 months of follow-up.
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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:
-
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.
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Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital La Carlota | Montemorelos | Nuevo Leon | Mexico |
Sponsors and Collaborators
- Rush Eye Associates
Investigators
- Study Chair: Sloan Rush, MD, panhandle eye group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Retina 4