Repositioning the peeled inner limiting membrane to treat macular holes
Official title: PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Single-centre, Randomized, Prospective Controlled Trial
Run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · NCT06359548 · Data updated 2026-11-12
This study is testing a new surgery that moves a part of the eye to help close macular holes in older patients, instead of removing it like usual.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 90 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | April 15, 2024 |
| Main results expected | June 2026 |
| Study ends | November 2026 |
| Registry record updated | April 11, 2024 |
| Trial ID | NCT06359548 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 50 to 80 years with a diagnosed macular hole measuring 600 µm or less.
✕Probably not a fit
Patients with traumatic macular holes or other serious ocular conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates a novel surgical technique for treating macular holes by repositioning the peeled inner limiting membrane (ILM) instead of the conventional ILM peeling method. The approach aims to preserve the integrity of the internal retina while effectively closing the macular hole. Patients aged 50 to 80 years diagnosed with macular holes of a specific size will be recruited for this intervention. The study seeks to evaluate the effectiveness and safety of this new technique compared to traditional methods.
Why it matters
Potential benefit: If successful, this technique could improve visual outcomes and quality of life for patients with macular holes.
How similar studies have gone: Previous pilot studies have suggested that this novel approach may achieve better morphological and functional outcomes compared to traditional ILM peeling.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patients are diagnosed as MH with a diameter ≤ 600 µm by optical coherence tomography. 2. Age ranges from 50 to 80 years. 3. Do not participate in other clinical studies. 4. Agree to sign an informed consent form with good compliance. Exclusion Criteria: 1. Traumatic macular hole. 2. Combined with serious epiretinal membrane. 3. Combined with diabetic retinopathy, hypertensive retinopathy. 4. Combined with other ocular diseases, such as keratitis,uveitis,retinal vasculitis. 5. Spherical equivalent ≥ -6.0 diopters or axial length ≥ 26 mm. 6. History of intraocular surgery. 7. Presence of staphyloma. 8. Other ocular diseases that influence macular microstructure or visual function.
Where it's running
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Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School
Shanghai, China Recruiting
Study contacts
- Principal investigator: Tian Tian, MD,PhD — Xinhua Hospital, Shanghai Jiaotong University School of Medicine
- Study coordinator: Tian Tian, MD,PhD
- Email: tiantianoph@163.com
- Phone: +8615216695095
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.