NCT07271719Active, not recruiting
Fovea Sparing ILM Peeling in Diabetic Patients
Fovea Sparing ILM Peeling vs Complete ILM Peeling in Diabetic Patients With Proliferative Diabetic Retinopathy (PDR) Indicated for Pars Plana Vitrectomy (PPV).
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 21 Nov 2025
- Start date
- 5 Jun 2025
- Primary completion date
- Dec 2025
- Lead sponsor
- David Nashaat Shafik Fahmy
- Diseases
- Diabetic eye disease
- NCT number
- NCT07271719
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 5 Jun 2025 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous RVO or RAO.
Other illness
- Any history of or pre-existing ocular pathology such as glaucoma, uveitis….etc.
- Systemic diseases with possible ocular involvement e.g. collagen vascular diseases.
Who the study is looking for
- Diabetic patients (both type 1 and II) with evident epiretinal membrane (ERM) and/or vitreo-macular traction (VMT)) inducing cystoid edema or foveoschisis detected either preoperatively or intraoperatively in cases with dense vitreous hemorrhage that can impair preoperative macular evaluation.
- Visual acuity of HMGP or better.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Cairo University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.