Idiopathic Epiretinal MembraneNCT07767539
Macular Resurfacing Using Autologous ILM Patch Transposition for Idiopathic Epiretinal Membrane
A study testing Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch Transposition and Conventional Epiretinal Membrane and Internal Limiting Membrane Peeling in people with Idiopathic Epiretinal Membrane, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Epiretinal Membrane
- What is being tested?
- Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch Transposition and Conventional Epiretinal Membrane and Internal Limiting Membrane Peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 9 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Idiopathic Epiretinal Membrane
- Being tested
- Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch Transposition, Conventional Epiretinal Membrane and Internal Limiting Membrane Peeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch TranspositionProcedure or 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 PeelingProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Non-Inverted Autologous ILM Patch Transposition Group | Experimental | Not described Receives: Procedure: Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch Transposition |
| Conventional ERM/ILM Peeling Group | Active comparator | Not described Receives: Procedure: Conventional Epiretinal Membrane and Internal Limiting Membrane Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start10 Sep 2026 (estimated)
- Primary completion9 Aug 2027 (estimated)
- Study completion9 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Epiretinal MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiquan Zhao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767539
- Sponsor's protocol ID
- XH-2026-042
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Resurfacing With Non-Inverted Autologous Internal Limiting Membrane Patch Transposition for Idiopathic Epiretinal Membrane: A Multidimensional Evaluation of Efficacy and Foveal Microstructural Remodeling
- ClinicalTrials.gov ID
- NCT07767539
- Acronym / sponsor ID
- XH-2026-042
- Conditions
- Idiopathic Epiretinal Membrane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 9 Aug 2027 (estimated)
- Study completion
- 9 Aug 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Inverted Autologous ILM Patch Transposition Group | Experimental | Procedure: Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch Transposition |
| Conventional ERM/ILM Peeling Group | Active comparator | Procedure: Conventional Epiretinal Membrane and Internal Limiting Membrane Peeling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch TranspositionAfter 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. | Procedure or surgery | Non-Inverted Autologous ILM Patch Transposition Group |
| Conventional Epiretinal Membrane and Internal Limiting Membrane PeelingAfter 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. | Procedure or surgery | Conventional ERM/ILM Peeling Group |
Primary outcome
Best Corrected Visual Acuity
Time frame: From baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch Transposition and Conventional Epiretinal Membrane and Internal Limiting Membrane Peeling in people with Idiopathic Epiretinal Membrane, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: From baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.