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Fovea Sparing ILM Peeling in Diabetic Patients

NCT07271719 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-09

No results posted yet for this study

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).

Conditions

Interventions

PROCEDURE

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

PROCEDURE

PPV with total ILM peeling

PPV with total ILM peeling in which the whole area in between the arcades is peeled

Sponsors & Collaborators

  • David Nashaat Shafik Fahmy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07271719 on ClinicalTrials.gov