NCT06433284 Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
| NCT ID | NCT06433284 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Walailak University |
| Condition | Macular Holes |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2024-10-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * \>18 years old * idiopathic full thickness macular hole \> 400 micron of diameter * phakic or pseudophakic * absence of systemic adverse conditions Exclusion Criteria: * 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
Contact & Investigator
Jakkrit Juhong, MD.
PRINCIPAL INVESTIGATOR
School of Medicine, Walailak university
Frequently Asked Questions
Who can join the NCT06433284 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Macular Holes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06433284 currently recruiting?
Yes, NCT06433284 is actively recruiting participants. Contact the research team at jakkrit.ju@wu.ac.th for enrollment information.
Where is the NCT06433284 trial being conducted?
This trial is being conducted at Nakhon Si Thammarat, Thailand.
Who is sponsoring the NCT06433284 clinical trial?
NCT06433284 is sponsored by Walailak University. The principal investigator is Jakkrit Juhong, MD. at School of Medicine, Walailak university. The trial plans to enroll 26 participants.