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Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes

RecruitingNAAges 18 Years - anyAllWalailak University
NCT06433284 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The human amniotic membrane (hAM) patch, introduced by Rizzo et al. in 2018, showed a 100% anatomical success rate for large or failed macular holes over a 6-month follow-up. Despite its regenerative properties like promoting angiogenesis and having low immunogenicity, its clinical use is limited by challenges such as trimming to fit small holes and complications during insertion. To overcome these issues, decellularized amniotic membrane (dAM) has been processed into a hydrogel form, enhancing its applicability and allowing it to be used as an injectable hydrogel for minimally invasive therapies. While dAM hydrogels have been used in various medical fields, their application in intraocular surgery is new. This study proposes using dAM hydrogel for large macular hole closure, comparing its effectiveness to the inverted ILM flap technique in a randomized controlled trial.

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📋 Eligibility rules (as published)
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
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What it tests

  • 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade
  • 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade
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Where

1 site
Jakkrit Juhong
Nakhon Si Thammarat, Thailand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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