About this trial
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.
Eligibility criteria
Qualifiers
>18 years old
idiopathic full thickness macular hole > 400 micron of diameter
phakic or pseudophakic
absence of systemic adverse conditions
Disqualifiers
idiopathic full thickness macular hole > 1,500 micron of diameter
traumatic macular holes
myopic macular holes,
concomitant retinal and other ocular disease
Trial design
Treatments tested in this trial
- 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