ILM Peeling in PDR Patients Undergoing PPV for VH

Diabetic Retinopathy Clinical Trial

Official title:

Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Vitreous Hemorrhaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660371
• Other study ID #: Retina 2
• Status: Completed
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: March 4, 2020

Study information

• Verified date: November 2021
• Source: Rush Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects undergoing ILM peeling during vitrectomy will have better visual acuity and lower rates of DME to control subjects

Description:

Proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME) frequently occur together in patients with diabetic retinopathy In the landmark study Protocol S, about 30% of PDR subjects had DME at baseline and 53% of subjects receiving panretinal photocoagulation (PRP) underwent treatment for DME during the 2-year study interval. Vitreous hemorrhaging is one of the most common indications for pars plana vitrectomy (PPV) in patients with PDR. PDR patients undergoing PPV for the treatment of vitreous hemorrhaging often have coexisting DME, although it is often difficult to identify preoperatively because of the media opacification from the vitreous hemorrhage. Following successful PPV and vitreous hemorrhage resolution, PDR patients may then require prolonged DME treatment with repetitive intravitreal injections and/or focal lasers.

PPV with internal limiting membrane (ILM) peeling has been reported to reduce retinal edema and improve visual acuity in patients with DME. Although numerous studies report favorable outcomes in patients undergoing PPV with ILM peeling for the surgical indication of DME, there are presently not any studies evaluating ILM peeling in PDR patients undergoing PPV for the primary indication of vitreous hemorrhaging. Performing ILM peeling in conjunction with the usual techniques for addressing a vitreous hemorrhage (i.e. endolaser PRP, endodiathermy, etc.) during PPV may offer the benefits of better postoperative visual acuity and/or fewer postoperative treatments required to manage DME. In this randomized controlled trial, the authors evaluate the merits of ILM peeling in PDR patients undergoing PPV for the primary indication of vitreous hemorrhaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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 reduced BCSVA from vitreous hemorrhaging without substantial vitreoretinal (VR) adhesion (Grades 0 and 1).

Exclusion Criteria:

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 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 a retinal detachment in the study eye.

5. Subject has had a previous vitrectomy (anterior or PPV) in the study eye.

6. Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.

7. 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
• Macular Edema
• Retinal Diseases

Intervention

Procedure:
• PPV/MP
Internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging
• PPV without MP
No internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

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	BCVA	best-corrected visual acuity	6 months