Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07019896

Minimal Vitrectomy Surgery Versus Conventional Vitrectomy for Idiopathic Epiretinal Membrane Treatment: A Multicenter Randomized Controlled Trial

Led by Peking Union Medical College Hospital · Updated on 2025-06-13

140

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

P

Peking Union Medical College Hospital

Lead Sponsor

P

Peking Union Medical College

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare two surgical methods for idiopathic epiretinal membrane (ERM), a condition where abnormal cell growth on the retina causes swelling, distorted vision, and visual loss. The trial evaluates Minimal Vitrectomy Surgery (MVS), a newer approach designed to reduce the amount of vitreous removed during surgery, against the conventional vitrectomy method. The study focuses on improvements in visual acuity and cataract progression over 12 months. Participants will receive either Minimal Vitrectomy Surgery, where the membrane is peeled through the intact vitreous and limited vitrectomy is selectively done if floaters or membrane fragments remain, or conventional vitrectomy involving standard removal of vitreous and membrane peeling. The study is randomized and conducted across multiple centers, with each surgical method carefully defined and monitored. During the trial, participants will undergo assessments including visual acuity tests, cataract evaluations using LOCS III and DLI, and measurements of central retinal thickness by OCT. These evaluations occur from baseline through intervals up to 12 months. Researchers will also monitor for membrane recurrence and surgical complications. The total participation includes a follow-up period of one year after surgery.

CONDITIONS

Brief Title

Minimal Vitrectomy Surgery for Epiretinal Membrane

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed diagnosis of idiopathic epiretinal membrane by clinical examination and OCT imaging
  • Clear ocular media allowing quality fundus imaging
  • Phakic eye (natural lens present)
  • Ability and willingness to provide written informed consent
Not Eligible

You will not qualify if you...

  • Prior cataract surgery or advanced cataract requiring combined surgery
  • Presence of other retinal diseases such as diabetic retinopathy, retinal detachment, or retinal vein occlusion
  • Systemic health conditions that prevent safe surgery or follow-up
  • History of prior ocular or periocular corticosteroid use, including injections or long-term eye drops for the eyes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo either Minimal Vitrectomy Surgery or Conventional Vitrectomy to treat idiopathic epiretinal membrane.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 12 months

Participants are followed after surgery to monitor vision improvement, macular thickness, cataract progression, and possible membrane recurrence.

Follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months (in-person)

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

W

Weihong Yu, MD

X

Xufeng Zhao

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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