Decellularized amniotic membrane hydrogel vs inverted ILM flap for large 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

Participants are adults with idiopathic large macular holes undergoing pars plana vitrectomy. The study randomizes to two surgical approaches: 25-gauge vitrectomy with an inverted ILM flap and SF6 tamponade, or 25-gauge vitrectomy with complete ILM peeling followed by filling the hole with decellularized amniotic membrane hydrogel and SF6 tamponade. Outcomes focus on anatomical hole closure and visual function over approximately six months. The dAM hydrogel is being explored to simplify application and potentially improve healing in large holes. This is a randomized controlled comparison of a novel injectable hydrogel approach versus a surgical tissue flap technique.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age ≥18 years Idiopathic full-thickness macular hole with minimum diameter \>400 µm confirmed on SD-OCT Willing and able to provide written informed consent and comply with 6-month follow-up schedule

Exclusion Criteria:

Full-thickness macular hole with minimum diameter \>1,500 µm Traumatic macular holes Myopic macular holes (axial length \>26.5 mm or refractive error less than -8.0 diopters) Co-existing ocular pathologies independently affecting visual acuity (glaucoma with visual field loss, advanced age-related macular degeneration, diabetic macular edema, or epiretinal membrane requiring surgery) Active intraocular inflammation or infection Previous vitreoretinal surgery Medical unfitness for local anesthesia surgery as determined by the anesthesiologist Inability to maintain prone positioning postoperatively

Where it's running

• Jakkrit Juhong
  Nakhon Si Thammarat, Thasala, Thailand Recruiting

Study contacts

• Principal investigator: Jakkrit Juhong, MD. — School of Medicine, Walailak university
• Study coordinator: Jakkrit Juhong, MD.
• Email: jakkrit.ju@wu.ac.th
• Phone: +66816773406

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

• 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

• Using advanced imaging technology during eye surgery

  This study is testing a new imaging technology during eye surgery to see if it can help doctors perform better and improve outcomes for patients with retinal diseases.

  Recruiting Duke University · Durham, North Carolina · NCT03713268

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.