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

NCT06433284 | Enrolling By Invitation

• 1 other identifier: WU999
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

macular holes; decellularized amniotic membrane; human amniotic membrane hydrogel

Outcome Measures

Primary Outcomes (2)

• Best corrected visual acuity (BCVA)

  Difference of best corrected visual acuity (BCVA) after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique

  6 months

• Closure rate

  Closure rate after primary vitrectomy for idiopathic full thickness macular holes with decellularized amniotic membrane hydrogel versus inverted flap technique

  6 months

Study Arms (2)

Inverted flap

ACTIVE COMPARATOR

Patients who will undergo 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade.

Procedure: 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade

Amniotic membrane hydrogel

EXPERIMENTAL

Patients who will undergo 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling, amniotic membrane hydrogel filling and SF6 tamponade.

Procedure: 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade

Interventions

25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade PROCEDURE

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

Inverted flap

25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade PROCEDURE

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

Amniotic membrane hydrogel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walailak University: lead

Study Sites (1)

Jakkrit Juhong

Nakhon Si Thammarat, Thasala, 80160, Thailand

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Jakkrit Juhong, MD.

  School of Medicine, Walailak university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Vitreoretinal unit, Ophthalmology department, Walailak University

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

TH (1)