Fovea Sparing ILM Peeling in Diabetic Patients

NCT07271719 | Active Not Recruiting

• 1 other identifier: ILM peeling in diabetic pts
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Undergo surgery (PPV) with either foveal sparing ILM peeling or total ILM peeling.
3. 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. 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

Diabetes Mellitus

Keywords

Proliferative diabetic retinoptahy; Pars plana vitrectomy (PPV); Fovea paring ILM peeling

Outcome Measures

Primary Outcomes (1)

• Functional outcome

  comparing postoperative best corrected visual acuity (BCVA) between both groups

  6 months from the surgery

Secondary Outcomes (1)

• Anatomical outcome

  6 months from the surgery

Study Arms (2)

Fovea sparing internal limiting membrane (ILM) peeling group

ACTIVE COMPARATOR

Fovea sparing ILM peeling in diabetic patients with proliferative diabetic retinopathy (PDR) indicated for pars plana vitrectomy (PPV)

Procedure: Pars plana vitrectomy (PPV) with fovea sparing ILM peeling.

Total ILM peeling group

ACTIVE COMPARATOR

Total ILM peeling in diabetic patients with PDR indicated for PPV

Procedure: PPV with total ILM peeling

Interventions

Pars plana vitrectomy (PPV) with fovea sparing ILM peeling. PROCEDURE

PPV with fovea sparing ILM peeling in which an area of one disc diameter will not be peeled over the fovea

Fovea sparing internal limiting membrane (ILM) peeling group

PPV with total ILM peeling PROCEDURE

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

Total ILM peeling group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any history of or pre-existing ocular pathology such as glaucoma, uveitis….etc.
• History of previous RVO or RAO.
• Systemic diseases with possible ocular involvement e.g. collagen vascular diseases.

Sponsors & Collaborators

• David Nashaat Shafik Fahmy: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Predictive Value of Tests

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sensitivity and Specificity; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of ophthalmology

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 9, 2025
• Study Start: June 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)