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Fovea Sparing ILM Peeling in Diabetic Patients
Sponsor: David Nashaat Shafik Fahmy
Summary
The goal of this clinical trial is to compare between foveal sparing ILM peeling and total ILM peeling in diabetic patients (both type 1 and II) with proliferative diabetic retinopathy (PDR) indicated for pars plana vitrectomy (PPV) on functional and anatomical outcomes regarding postoperative best corrected visual acuity (BCVA), measuring central subfield thickness and evaluation of morphology and integrity of inner retinal layers (including vitreoretinal interface) and the outer retinal layers (especially the ellipsoid zone) using macular OCT. Researchers will compare compare between foveal sparing internal limiting membrane (ILM) peeling and total ILM peeling in diabetic patients indicated for PPV on functional and anatomical outcomes regarding postoperative BCVA, and integrity of inner and the outer retinal layers using macular OCT. Participants will: 1. Undergo preoperative full ophthalmic examination, routine labs and investigations and OCT macula if media allows visualization of the macula to evaluate the vitreoretinal interface and vitreomacular traction (VMT) macular edema, obtain the central subfield thickness and to assess the integrity of the ellipsoid zone. 2. Undergo surgery (PPV) with either foveal sparing ILM peeling or total ILM peeling. 3. Visit the clinic postoperatively for follow-up at 1-day, 1-week, 1-month, 3-months and 6-months intervals to undergo complete slit lamp examination, and fundus examination using slit lamp biomicroscoby. measure BCVA 4. Undergo OCT macula at 1,3 and 6 months postoperatively to obtain central subfield thickness (CST) and to evaluate morphology and integrity of inner retinal layers (including vitreoretinal interface) and the outer retinal layers (especially the ellipsoid zone).
Official title: Fovea Sparing ILM Peeling vs Complete ILM Peeling in Diabetic Patients With Proliferative Diabetic Retinopathy (PDR) Indicated for Pars Plana Vitrectomy (PPV).
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-06-05
Completion Date
2026-01
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
Pars plana vitrectomy (PPV) with fovea sparing ILM peeling.
PPV with fovea sparing ILM peeling in which an area of one disc diameter will not be peeled over the fovea
PPV with total ILM peeling
PPV with total ILM peeling in which the whole area in between the arcades is peeled
Locations (1)
Faculty of medicine, Cairo University
Cairo, Egypt