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

ConditionMacular Holes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWalailak University

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

Treatment groups

26 Participants
are divided into 2 treatment groups

Sponsors and collaborators