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Recruiting NCT07019896

Minimal Vitrectomy Surgery for Epiretinal Membrane

No phase Interventional Epiretinal Membrane Macular Edema (ME) Nuclear Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Minimal Vitrectomy Surgery, Conventional Vitrectomy.
Who it may be relevant to
Registry conditions: Epiretinal Membrane, Macular Edema (ME), Nuclear Cataract. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Cataract progression assessed by LOCS III and DLI [Time frame: Baseline, 12 months]
Secondary outcome measures (3)
  • BCVA change from baseline to 12 months [Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months]
  • Change in central retinal thickness (CRT) by OCT [Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months]
  • Epiretinal membrane recurrence rate [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07019896 · 2024-I2M-C&T-B-028 · K4698

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗