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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Retinopathy Visually Threatening
• Intervention / Treatment: Procedure: ILM Peeling; Procedure: No ILM Peeling

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Montemorelos, Nuevo Leon, Mexico
      • Hospital La Carlota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion:

1. Subject age is 18-85 years.
2. Subject consents to study participation and is capable of 6 months of follow-up.
3. The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
4. Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
5. The subject is determined to need a PPV for the indication of TRD (Grades 2 and 3).

Exclusion:

1. Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
2. Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye.
3. Subject has a significant corneal or cataract opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
4. Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
5. Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
6. Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment	Procedure: ILM Peeling; ILM peeling performed during primary PPV for PDR
Active Comparator: Control Group; Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment	Procedure: No ILM Peeling; ILM peeling not performed during primary PPV for PDR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative ERM Development	Postoperative Epiretinal Membrane Development	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Rate of subjects achieving 20/50 or better Snellen visual acuity	6 months

Collaborators and Investigators

• Sponsor: Rush Eye Associates
• Investigators: Study Chair: Sloan Rush, MD, panhandle eye group

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: Retina 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No