Repositioning the peeled inner limiting membrane to treat macular holes

PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Single-centre, Randomized, Prospective Controlled Trial

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06359548 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 to 80 years with a diagnosed macular hole measuring 600 µm or less.

Not a fit: Patients with traumatic macular holes or other serious ocular conditions may not benefit from this study.

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 performed: Previous pilot studies have suggested that this novel approach may achieve better morphological and functional outcomes compared to traditional ILM peeling.

Eligibility 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 this trial is running

Shanghai

• 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

Conditions Macular Holes