NCT03660371

ILM Peeling in PDR Patients Undergoing PPV for VH

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Rush Eye Associates · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Diabetic Retinopathy
• Macular Edema

Interventions

Type	Name	Description
PROCEDURE	PPV/MP	Internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging
PROCEDURE	PPV without MP	No internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

Timeline

• Start date: 2018-09-04
• Primary completion: 2020-03-04
• Completion: 2020-03-04
• First posted: 2018-09-06
• Last updated: 2021-12-02

Locations

1 site across 1 country: Mexico