Macular Resurfacing Using Autologous ILM Patch Transposition for Idiopathic Epiretinal Membrane

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch Transposition

    Procedure/Surgery

    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.

  • Conventional Epiretinal Membrane and Internal Limiting Membrane Peeling

    Procedure/Surgery

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Non-Inverted Autologous ILM Patch Transposition GroupExperimental treatment 1 intervention
Group B: Conventional ERM/ILM Peeling GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Best Corrected Visual Acuity

Time frame
From baseline to 12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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