Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

Diabetic Retinopathy Visually Threatening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04380064
• Other study ID #: Retina 4
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: February 1, 2025

Study information

• Verified date: November 2023
• Source: Rush Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Diabetic Retinopathy Visually Threatening
• Retinal Diseases

Intervention

Procedure:
• ILM Peeling
ILM peeling performed during primary PPV for PDR
• No ILM Peeling
ILM peeling not performed during primary PPV for PDR

Locations

Country	Name	City	State
Mexico	Hospital La Carlota	Montemorelos	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Rush Eye Associates

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative ERM Development	Postoperative Epiretinal Membrane Development	6 months
Secondary	Visual Acuity	Rate of subjects achieving 20/50 or better Snellen visual acuity	6 months