Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07019896

Minimal Vitrectomy Surgery for Epiretinal Membrane

Minimal Vitrectomy Surgery (MVS) Versus Conventional Vitrectomy for the Treatment of Idiopathic Epiretinal Membrane: A Multicenter Randomized Controlled Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
140 (estimated)
Sponsor
Peking Union Medical College Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This multicenter randomized controlled trial evaluates Minimal Vitrectomy Surgery (MVS) versus conventional vitrectomy for idiopathic epiretinal membrane (ERM). The primary endpoints include visual acuity improvement and cataract progression after 12 months. MVS aims to minimize vitreous removal while ensuring complete membrane removal through adaptive limited vitrectomy.

Detailed description

Idiopathic epiretinal membrane (ERM) is characterized by fibrocellular proliferation on the retinal surface, leading to macular edema, metamorphopsia, and visual impairment. Traditional treatment involves pars plana vitrectomy (PPV) with posterior vitreous detachment (PVD) induction and core vitrectomy, which may increase the risk of postoperative cataract. Minimal Vitrectomy Surgery (MVS) is a modified surgical approach designed to minimize vitreous removal and preserve the hyaloid. The epiretinal membrane is directly peeled through the intact vitreous. If pre-existing vitreous floaters or membrane fragments remain after peeling and cannot be removed safely with micro-forceps, limited localized vitrectomy is selectively performed to eliminate these floaters and avoid postoperative visual disturbances. This trial aims to evaluate the efficacy and safety of MVS compared to conventional vitrectomy, focusing on visual improvement, macular thickness, cataract progression, ERM recurrence, and intraoperative complications.

Conditions

Interventions

TypeNameDescription
PROCEDUREMinimal Vitrectomy SurgeryThe epiretinal membrane is peeled directly through the intact vitreous. Limited localized vitrectomy is selectively performed if pre-existing floaters or membrane fragments remain after peeling.
PROCEDUREConventional VitrectomyStandard pars plana vitrectomy is performed with posterior vitreous detachment induction and core vitreous removal prior to epiretinal membrane peeling.

Timeline

Start date
2024-12-01
Primary completion
2026-11-30
Completion
2026-11-30
First posted
2025-06-13
Last updated
2025-06-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07019896. Inclusion in this directory is not an endorsement.