Macular Resurfacing Using Autologous ILM Patch Transposition for Idiopathic Epiretinal Membrane

August 15, 2026 updated by: Peiquan Zhao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Macular Resurfacing With Non-Inverted Autologous Internal Limiting Membrane Patch Transposition for Idiopathic Epiretinal Membrane: A Multidimensional Evaluation of Efficacy and Foveal Microstructural Remodeling

Idiopathic epiretinal membrane is a condition in which abnormal tissue grows on the surface of the retina and can cause blurred vision and distortion. The standard surgical treatment is removal of this membrane, but some patients may not achieve complete visual recovery because the normal structure of the central retina may not fully restore after surgery.

This study is a prospective randomized controlled trial designed to evaluate a new surgical technique called macular resurfacing using an autologous internal limiting membrane patch transposition. The technique uses a patient's own retinal tissue to cover the macular area after epiretinal membrane removal, with the aim of promoting more natural healing of the retinal surface.

Patients with idiopathic epiretinal membrane will be randomly assigned to receive either the new surgical technique or conventional epiretinal membrane peeling. Visual function and retinal structural changes will be evaluated using visual examinations and multimodal retinal imaging during follow-up. The study aims to determine whether this new technique can improve visual outcomes and promote better restoration of macular microstructure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of epiretinal membrane confirmed by Spectral-domain Optical Coherence Tomography
  • Best corrected visual acuity <= 0.8 (equivalent to 0.1 LogMAR)
  • Presence of metamorphopsia confirmed by Amsler grid testing
  • Ability to understand the study information and provide written informed consent voluntarily

Exclusion Criteria:

  • History of intraocular surgery, with the exception of uncomplicated cataract surgery
  • Presence of any of the following ocular diseases: retinal vascular diseases (including diabetic retinopathy, retinal hemangioma, retinal vascular occlusion, Coats' disease, etc.), uveitis, macular degeneration, macular hole, retinal detachment, retinoschisis, pathologic myopia, ocular trauma, intraocular tumor and neurofibromatosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Inverted Autologous ILM Patch Transposition Group
Procedure: Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch Transposition
After standard pars plana vitrectomy and epiretinal membrane removal, the internal limiting membrane (ILM) was peeled from the central fovea to the vascular arcades. A piece of healthy ILM free of ERM from the paramacular region was prepared as a patch for subsequent coverage, while its pedicle remained anchored to the paramacular site. A perfluorocarbon liquid bubble was injected into the vitreous cavity to flatten the ILM patch and facilitate manipulation. The patch was then detached and carefully transposed to resurface the macular area.
Active Comparator: Conventional ERM/ILM Peeling Group
Procedure: Conventional Epiretinal Membrane and Internal Limiting Membrane Peeling
After standard pars plana vitrectomy and epiretinal membrane removal, the ILM was peeled from the central fovea to the vascular arcades, without additional ILM patch transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual Acuity
Time Frame: From baseline to 12 months
From baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

August 9, 2027

Study Completion (Estimated)

August 9, 2028

Study Registration Dates

First Submitted

August 12, 2026

First Submitted That Met QC Criteria

August 12, 2026

First Posted (Actual)

August 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 15, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • XH-2026-042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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