NCT04380064

Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Tractional Retinal Detachment: a Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rush Eye Associates · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Retinopathy Visually Threatening

Interventions

Type	Name	Description
PROCEDURE	ILM Peeling	ILM peeling performed during primary PPV for PDR
PROCEDURE	No ILM Peeling	ILM peeling not performed during primary PPV for PDR

Timeline

• Start date: 2020-05-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2020-05-08
• Last updated: 2023-11-18

Locations

1 site across 1 country: Mexico