Health TrialsbyHealthPanel

Minimal Vitrectomy Surgery for Epiretinal Membrane

ConditionsEpiretinal MembraneMacular Edema (ME)Nuclear Cataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minimal Vitrectomy Surgery

    Procedure/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.

  • Conventional Vitrectomy

    Procedure/Surgery

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Minimal Vitrectomy Surgery (MVS)Experimental treatment 1 intervention
Group B: Conventional Vitrectomy (PPV)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cataract progression assessed by LOCS III and DLI

Cataract progression evaluated by Lens Opacities Classification System III (LOCS III) grading and Dysfunctional Lens Index (DLI) changes.

Time frame
Baseline, 12 months

Secondary outcomes

1

BCVA change from baseline to 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
2

Change in central retinal thickness (CRT) by OCT

Change in macular central retinal thickness as assessed by OCT.

Time frame
Baseline, 1 week, 1 month, 3 months, 6 months, 12 months
3

Epiretinal membrane recurrence rate

Recurrence of epiretinal membrane at 12-month follow-up.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Peking Union Medical College

Collaborator

Source ClinicalTrials.gov
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