Minimal Vitrectomy Surgery (MVS) Versus Conventional Vitrectomy for the Treatment of Idiopathic Epiretinal Membrane: A Multicenter Randomized Controlled Trial
| Registry | NCT07019896, acronym MVS-ERM |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 140 (Estimated) |
| Sponsor | Peking Union Medical College Hospital (Other); collaborators: Peking Union Medical College |
| Conditions | Epiretinal Membrane, Macular Edema (ME), Nuclear Cataract |
| Interventions | Minimal Vitrectomy Surgery, Conventional Vitrectomy (Procedure) |
| Dates | start 2024-12-01, primary completion 2026-11-30 (estimated), completion 2026-11-30 (estimated), first posted 2025-06-13, last updated 2025-06-13 |
| Locations | 1 site in China |
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All trials for Epiretinal Membrane All trials for Macular Edema (ME) All trials of Minimal Vitrectomy Surgery All trials of Conventional Vitrectomy
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Minimal Vitrectomy Surgery (MVS) | Experimental | Procedure: Minimal Vitrectomy Surgery | 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. |
| Conventional Vitrectomy (PPV) | Active comparator | Procedure: Conventional Vitrectomy | Standard pars plana vitrectomy is performed. Posterior vitreous detachment induction and core vitreous removal are conducted before membrane peeling. |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Peking Union Medical College Hospital | Beijing, Beijing Municipality | China | Recruiting |