Minimal Vitrectomy Surgery for Epiretinal Membrane

NCT ID: NCT07019896

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-11-30

Brief Summary

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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

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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

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Epiretinal Membrane Macular Edema (ME) Nuclear Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a multicenter, randomized, parallel-group controlled trial. Patients with idiopathic epiretinal membrane are randomly assigned to receive either Minimal Vitrectomy Surgery (MVS) or Conventional Pars Plana Vitrectomy (PPV). Randomization is stratified across 14 participating centers. Participants in the MVS group undergo membrane peeling without core vitrectomy or posterior vitreous detachment induction, with selective limited vitrectomy performed if necessary. The PPV group undergoes standard vitrectomy with core vitreous removal and posterior vitreous detachment prior to membrane peeling.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants are masked to the intervention arm assignment. Surgical staff, investigators, and outcomes assessors are not masked due to the nature of the surgical procedures.

Study Groups

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Minimal Vitrectomy Surgery (MVS)

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.

Group Type EXPERIMENTAL

Minimal Vitrectomy Surgery

Intervention Type PROCEDURE

The 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.

Conventional Vitrectomy (PPV)

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

Group Type ACTIVE_COMPARATOR

Conventional Vitrectomy

Intervention Type PROCEDURE

Standard pars plana vitrectomy is performed with posterior vitreous detachment induction and core vitreous removal prior to epiretinal membrane peeling.

Interventions

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Minimal Vitrectomy Surgery

The 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.

Intervention Type PROCEDURE

Conventional Vitrectomy

Standard pars plana vitrectomy is performed with posterior vitreous detachment induction and core vitreous removal prior to epiretinal membrane peeling.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weihong Yu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weihong Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weihong Yu, MD

Role: CONTACT

+8613671214306

Xufeng Zhao

Role: CONTACT

+8619121036553

Facility Contacts

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Role: primary

19121036553

Other Identifiers

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K4698

Identifier Type: OTHER

Identifier Source: secondary_id

2024-I2M-C&T-B-028

Identifier Type: -

Identifier Source: org_study_id

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