Clinical trial NCT07019896: Minimal Vitrectomy Surgery for Epiretinal Membrane
Official title: Minimal Vitrectomy Surgery (MVS) Versus Conventional Vitrectomy for the Treatment of Idiopathic Epiretinal Membrane: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epiretinal Membrane
Macular Edema (ME)
Nuclear Cataract
Keywords: Idiopathic Epiretinal Membrane (ERM)
Minimal Vitrectomy Surgery (MVS)
Nonvitrectomizing Vitreous Surgery (NVS)
pars plana Vitrectomy (PPV)
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College
First posted: 2025-06-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cataract progression assessed by LOCS III and DLI
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: BCVA change from baseline to 12 months
timeFrame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months
measure: Change in central retinal thickness (CRT) by OCT
timeFrame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months
measure: Epiretinal membrane recurrence rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Weihong Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: