Surgery for treating large idiopathic macular holes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Peiquan Zhao, Dr.
• Email: zhaopeiquan@xinhuamed.com.cn
• Phone: 0086 13311620396

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ten modern techniques for full-thickness macular hole repair compared

  We are testing ten different surgical approaches to fix full-thickness macular holes in adults to see which method closes the hole best and gives the best vision.

  Recruiting Kazakh Eye Research Institute · Almaty, Almaty · NCT07606404

• Comparing surgery times for UNITY® VCS and CONSTELLATION® Vision System

  This study will see if the UNITY® VCS or the CONSTELLATION® Vision System leads to shorter combined cataract and vitrectomy (phacovitrectomy) surgery times for adults planned for 25‑gauge procedures.

  Recruiting Alcon Research · Manchester · NCT07228091

• Decellularized amniotic membrane hydrogel vs inverted ILM flap for large macular holes

  This trial tests whether injecting decellularized human amniotic membrane hydrogel can close large macular holes as effectively as the inverted ILM flap technique after vitrectomy.

  Recruiting Walailak University · Nakhon Si Thammarat, Thasala · NCT06433284

• Repositioning the peeled inner limiting membrane to treat macular holes

  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.

  Recruiting Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai · NCT06359548

• Treatment of small macular holes using air

  This study tests whether using air instead of gas during surgery can help close small macular holes in the eyes for patients who have had them for less than a year.

  Recruiting at 6 sites Helse Stavanger HF · Thessaly, Thessaly and 6 other locations · NCT06211907

• Comparing face-down positioning durations after macular hole surgery

  This study is testing whether sitting face-down for 3 days or 7 days after macular hole surgery helps people heal better and see clearly.

  Recruiting St. Joseph's Healthcare Hamilton · Stoney Creek, Ontario · NCT06000111

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.