Minimal Vitrectomy Surgery for Epiretinal Membrane (MVS-ERM)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Nuclear Cataract; Epiretinal Membrane; Macular Edema (ME)

Treatments: Procedure: Conventional Vitrectomy; Procedure: Minimal Vitrectomy Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07019896

2024-I2M-C&T-B-028

K4698 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years.
2. Diagnosis of idiopathic epiretinal membrane (ERM) confirmed by clinical examination and OCT imaging.
3. Clear ocular media allowing adequate fundus imaging.
4. Phakic eye.
5. Ability and willingness to provide written informed consent.

Exclusion criteria

1. Prior cataract surgery or advanced cataract requiring combined surgery. Co-existing retinal diseases (e.g., diabetic retinopathy, retinal detachment, retinal vein occlusion).
2. Systemic conditions preventing safe surgery or follow-up.
3. History of prior ocular or periocular corticosteroid use, including intraocular injection, periocular injection, or long-term topical corticosteroid eye drops.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Minimal Vitrectomy Surgery (MVS)

Experimental group

Description:

The epiretinal membrane is peeled directly through the intact vitreous. Limited vitrectomy is selectively performed if pre-existing floaters or membrane fragments remain after peeling and cannot be removed safely with forceps.

Treatment:

Procedure: Minimal Vitrectomy Surgery

Conventional Vitrectomy (PPV)

Active Comparator group

Description:

Standard pars plana vitrectomy is performed. Posterior vitreous detachment induction and core vitreous removal are conducted before membrane peeling.

Treatment:

Procedure: Conventional Vitrectomy