Minimal Vitrectomy Surgery for Epiretinal Membrane

NCT07019896 | Recruiting

• 2 other identifiers: 2024-I2M-C&T-B-028K4698
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

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.

  Baseline, 12 months

Secondary Outcomes (3)

• BCVA change from baseline to 12 months

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

• Change in central retinal thickness (CRT) by OCT

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

• Epiretinal membrane recurrence rate

  12 months

Study Arms (2)

Minimal Vitrectomy Surgery (MVS)

EXPERIMENTAL

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.

Procedure: Minimal Vitrectomy Surgery

Conventional Vitrectomy (PPV)

ACTIVE COMPARATOR

Standard pars plana vitrectomy is performed. Posterior vitreous detachment induction and core vitreous removal are conducted before membrane peeling.

Procedure: Conventional Vitrectomy

Interventions

Minimal Vitrectomy Surgery PROCEDURE

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.

Minimal Vitrectomy Surgery (MVS)

Conventional Vitrectomy PROCEDURE

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

Conventional Vitrectomy (PPV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking Union Medical College: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Epiretinal Membrane; Macular Edema

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration

Study Officials

• Weihong Yu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weihong Yu, MD

CONTACT

+8613671214306; yuweihongpumch@163.com

Xufeng Zhao

CONTACT

+8619121036553; yezhong019@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked to the intervention arm assignment. Surgical staff, investigators, and outcomes assessors are not masked due to the nature of the surgical procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)