Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
NCT Number: NCT07019896
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Standard pars plana vitrectomy is performed with posterior vitreous detachment induction and core vitreous removal prior to epiretinal membrane peeling.
Time frame: Baseline, 12 months
Cataract progression evaluated by Lens Opacities Classification System III (LOCS III) grading and Dysfunctional Lens Index (DLI) changes.
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.
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months
Change in macular central retinal thickness as assessed by OCT.
Time frame: 12 months
Recurrence of epiretinal membrane at 12-month follow-up.
Contact information is provided by the study sponsor or research team.
Weihong Yu, MD
CONTACT
Xufeng Zhao
CONTACT
Peking Union Medical College Hospital
Other
Minimal Vitrectomy Surgery (MVS) Versus Conventional Vitrectomy for the Treatment of Idiopathic Epiretinal Membrane: A Multicenter Randomized Controlled Trial
Acronym: MVS-ERM
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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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