Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

Not Applicable

Active, not recruiting

• Conditions: Diabetic Retinopathy Visually Threatening

• Registration Number: NCT04380064
• Lead Sponsor: Rush Eye Associates

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 undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment

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 control subjects Randomization: Subjects will be randomized according to a coin toss during PPV, once Grade 2 or Grade 3 vitreoretinal adhesion has been determined: heads undergo ILM peeling, while tails do not.

Number of Subjects: With study power of 80%, a significance level of 0.05, a sample size of 60 patients for each group was calculated.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative ERM Development	6 months	Postoperative Epiretinal Membrane Development

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	6 months	Rate of subjects achieving 20/50 or better Snellen visual acuity

Trial Locations

Locations (1)

Hospital La Carlota; 🇲🇽 Montemorelos, Nuevo Leon, Mexico