Macular Resurfacing Using Autologous ILM Patch Transposition for Idiopathic Epiretinal Membrane
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Non-Inverted Autologous ILM Patch Transposition Group
|
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.
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Aktiv komparator: Conventional ERM/ILM Peeling Group
|
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Best Corrected Visual Acuity
Tidsramme: From baseline to 12 months
|
From baseline to 12 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- XH-2026-042
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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