Status:
UNKNOWN
Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy
Lead Sponsor:
Rush Eye Associates
Conditions:
Diabetic Retinopathy Visually Threatening
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
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 con...
Eligibility Criteria
Inclusion
- Inclusion:
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04380064
Start Date
May 1 2020
End Date
February 1 2025
Last Update
November 18 2023
Active Locations (1)
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1
Hospital La Carlota
Montemorelos, Nuevo León, Mexico