RecruitingNot ApplicableNCT06433284

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

Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes (MACROHOLE): a Randomized-control Trial


Sponsor

Walailak University

Enrollment

26 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • >18 years old
  • idiopathic full thickness macular hole > 400 micron of diameter
  • phakic or pseudophakic
  • absence of systemic adverse conditions

Exclusion Criteria5

  • idiopathic full thickness macular hole > 1,500 micron of diameter
  • traumatic macular holes
  • myopic macular holes,
  • concomitant retinal and other ocular disease
  • previous ocular surgery except cataract surgery

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Interventions

PROCEDURE25-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

PROCEDURE25-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

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NCT06433284


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