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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Walailak University • ClinicalTrials.gov ID: NCT06433284

Registry updated: 2026-09-09
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Description

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.

Interventions

  • 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade (Procedure)
    Standard 3 port 25-gauge pars plana vitrectomy with inverted flap technique after brilliant blue dye staining and SF6 tamponade. "Flower petal" type of inverted flap will be performed - multiple small ILM flaps will be created around the macular hole and placed over the macular hole
  • 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade (Procedure)
    Standard 3 port 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling around the macular hole after brilliant blue dye staining then filling the hole with amniotic membrane hydrogel and sulfur hexafluoride (SF6) tamponade

Eligibility criteria

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

Conditions

Macular Holes

Locations

  • Jakkrit Juhong — Nakhon Si Thammarat, Thasala, Thailand
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record