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NCT Number: NCT07019896

Minimal Vitrectomy Surgery for Epiretinal Membrane

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Minimal Vitrectomy Surgery

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

Procedure

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

Primary outcomes

  1. Cataract progression assessed by LOCS III and DLI

    Time frame: Baseline, 12 months

    Cataract progression evaluated by Lens Opacities Classification System III (LOCS III) grading and Dysfunctional Lens Index (DLI) changes.

Secondary outcomes

  1. BCVA change from baseline to 12 months

    Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months

    Change in best-corrected visual acuity (logMAR) from baseline to 12 months postoperatively.

  2. Change in central retinal thickness (CRT) by OCT

    Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months

    Change in macular central retinal thickness as assessed by OCT.

  3. Epiretinal membrane recurrence rate

    Time frame: 12 months

    Recurrence of epiretinal membrane at 12-month follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Weihong Yu, MD

CONTACT

[email protected]

+8613671214306

Xufeng Zhao

CONTACT

[email protected]

+8619121036553

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Peking Union Medical College

Registry information

Official study title

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

Acronym: MVS-ERM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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