Surgery for treating large idiopathic macular holes

Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole

This study is testing a new surgical method for treating large macular holes to see if it helps people see better and improves their quality of life compared to the standard surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 55 Years to 70 Years
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06063005 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of a new surgical technique involving the translocation of the internal limiting membrane (ILM) flap compared to traditional surgery for large idiopathic macular holes. It is a prospective randomized controlled trial designed to assess improvements in visual function, anatomical healing of the retina, and overall quality of life for patients. Participants will undergo either the new surgical approach or the conventional method, with outcomes monitored through follow-up assessments.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with idiopathic macular holes measuring between 500 and 900 µm in diameter and who meet specific ocular criteria.

Not a fit: Patients with other retinal disorders or high myopia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve visual outcomes and quality of life for patients with large idiopathic macular holes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving surgical outcomes for macular holes.

Eligibility criteria

Inclusion Criteria:

* Participants who can understand the purpose of this clinical trial, volunteer to participate, sign an informed consent form, and can complete the postoperative follow-up on time.
* Participants diagnosed with idiopathic macular hole (IMH).
* Based on OCT scans, the minimum horizontal diameter of the macular hole is \>500 and \<900 µm.
* Participants with an axial length \<26.0mm and a myopic degree lower than 6D.
* For participants with bilateral macular holes, the eye with a larger hole diameter will be included.

Exclusion Criteria:

* Patients with the following retinal disorders: age-related macular degeneration, epi-macular membrane neovascularization, non-macular retinal tears, lesions of the retinal pigment epithelium and choroid, inherited or degenerative retinal diseases, optic neuropathies, retinal vascular diseases; patients with large macular holes accompanied by retinal detachment;
* Patients with high myopia (axial length ≥ 26.0mm and myopia exceeding 6D);
* Patients with a history of ocular trauma or retinal laser treatment;
* Patients with glaucoma, ocular infections, inflammations, tumors, corneal diseases, or amblyopia;
* Patients with contraindications to vitrectomy;
* Patients with severe or unstable systemic diseases;
* Patients with a fasting blood glucose level ≥ 9mmol/L before surgery;
* Patients who participated in other clinical trials involving drugs or medical devices within 30 days prior to screening;
* Patients with a history of intraocular surgery within 3 months prior to screening;
* Patients with reduced visual function or vision in the contralateral eye as determined by the investigator;
* Patients who are not considered suitable for enrollment by the investigator for other reasons.

Where this trial is running

Shanghai

• Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Peiquan Zhao, Dr.

Conditions Macular Holes