Minimal Vitrectomy Surgery for Epiretinal Membrane

NCT07019896 — Not applicable, Recruiting, 140 participants, Peking Union Medical College Hospital

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

RegistryNCT07019896, acronym MVS-ERM
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment140 (Estimated)
SponsorPeking Union Medical College Hospital (Other); collaborators: Peking Union Medical College
ConditionsEpiretinal Membrane, Macular Edema (ME), Nuclear Cataract
InterventionsMinimal Vitrectomy Surgery, Conventional Vitrectomy (Procedure)
Datesstart 2024-12-01, primary completion 2026-11-30 (estimated), completion 2026-11-30 (estimated), first posted 2025-06-13, last updated 2025-06-13
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Epiretinal Membrane All trials for Macular Edema (ME) All trials of Minimal Vitrectomy Surgery All trials of Conventional Vitrectomy

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Minimal Vitrectomy Surgery (MVS)ExperimentalProcedure: Minimal Vitrectomy SurgeryThe 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.
Conventional Vitrectomy (PPV)Active comparatorProcedure: Conventional VitrectomyStandard pars plana vitrectomy is performed. Posterior vitreous detachment induction and core vitreous removal are conducted before membrane peeling.
  • 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.

+Outcome measures

Primary outcomes

  • Cataract progression assessed by LOCS III and DLI [Baseline, 12 months]: Cataract progression evaluated by Lens Opacities Classification System III (LOCS III) grading and Dysfunctional Lens Index (DLI) changes.

Secondary outcomes

  • BCVA change from baseline to 12 months [Baseline, 1 week, 1 month, 3 months, 6 months, 12 months]: Change in best-corrected visual acuity (logMAR) from baseline to 12 months postoperatively.
  • Change in central retinal thickness (CRT) by OCT [Baseline, 1 week, 1 month, 3 months, 6 months, 12 months]: Change in macular central retinal thickness as assessed by OCT.
  • Epiretinal membrane recurrence rate [12 months]: Recurrence of epiretinal membrane at 12-month follow-up.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Peking Union Medical College HospitalBeijing, Beijing MunicipalityChinaRecruiting

+Investigators

  • Weihong Yu, MD, Principal investigator, Peking Union Medical College Hospital