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

NCT06433284 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Macular Holes

Interventions

PROCEDURE

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

PROCEDURE

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

Sponsors & Collaborators

  • Walailak University

    lead OTHER

Principal Investigators

  • Jakkrit Juhong, MD. · School of Medicine, Walailak university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-08-30
Completion
2027-01-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06433284 on ClinicalTrials.gov