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Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
Sponsor: Walailak University
Summary
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.
Official title: Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes (MACROHOLE): a Randomized-control Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2024-10-01
Completion Date
2027-01-30
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade
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
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
Locations (1)
Jakkrit Juhong
Nakhon Si Thammarat, Thasala, Thailand