Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy
NCT ID: NCT04380064
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2020-05-01
2025-02-01
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Study Group
Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment
ILM Peeling
ILM peeling performed during primary PPV for PDR
Control Group
Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment
No ILM Peeling
ILM peeling not performed during primary PPV for PDR
Interventions
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ILM Peeling
ILM peeling performed during primary PPV for PDR
No ILM Peeling
ILM peeling not performed during primary PPV for PDR
Eligibility Criteria
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Inclusion Criteria
2. Subject consents to study participation and is capable of 6 months of follow-up.
3. The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
4. Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
5. The subject is determined to need a PPV for the indication of TRD (Grades 2 and 3).
Exclusion:
1. 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.
2. 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.
3. 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.
4. Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
5. Subject has uncontrolled neovascular glaucoma (intraocular pressure \> 30 mmHg despite medical/surgical treatment) in the study eye.
6. Subject has uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
18 Years
85 Years
ALL
No
Sponsors
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Rush Eye Associates
OTHER
Responsible Party
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Sloan W. Rush, MD
Physician
Principal Investigators
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Sloan Rush, MD
Role: STUDY_CHAIR
panhandle eye group
Locations
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Hospital La Carlota
Montemorelos, Nuevo León, Mexico
Countries
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Other Identifiers
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Retina 4
Identifier Type: -
Identifier Source: org_study_id
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