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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Parallel
25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade
Procedure/SurgeryStandard 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/SurgeryStandard 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
Closure rate
Type 1 anatomical closure rate at 6 months postoperatively, defined per the Gigante et al. classification as complete flattening of the macular hole with neurosensory retina fully covering the retinal pigment epithelium across the fovea on SD-OCT, assessed by a masked investigator on anonymized images.
Best corrected visual acuity (BCVA)
Change in best-corrected visual acuity (BCVA) from baseline to 6 months postoperatively, measured in logMAR by a masked assessor, comparing dAM hydrogel instillation versus inverted ILM flap technique.
EZ and ELM integrity
Ellipsoid zone (EZ) integrity grade (Continuous/Discontinuous/Absent) and external limiting membrane (ELM) continuity (Continuous/Discontinuous) at 6 months postoperatively on SD-OCT, graded by a masked investigator on anonymized images.
Intraocular pressure (IOP)
Change in intraocular pressure (IOP) from baseline to 6 months postoperatively, measured by Goldmann applanation tonometry.
Intraoperative and postoperative complications
Incidence of intraoperative and postoperative complications including intraocular inflammation (graded by SUN criteria), endophthalmitis, retinal detachment, elevated IOP requiring treatment, and cataract progression requiring surgery.
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Walailak University
Lead sponsor
Naresuan University
Collaborator