Vitrectomy Clinical Trials

Clinical trials related to Vitrectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>18 years old

• idiopathic full thickness macular hole \> 400 micron of diameter

• phakic or pseudophakic

• absence of systemic adverse conditions

Locations
Other Locations
Thailand
Jakkrit Juhong
RECRUITING
Nakhon Si Thammarat
Contact Information
Primary
Jakkrit Juhong, MD.
jakkrit.ju@wu.ac.th
+66816773406
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 26
Treatments
Active_comparator: Inverted flap
Patients who will undergo 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade.
Experimental: Amniotic membrane hydrogel
Patients who will undergo 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling, amniotic membrane hydrogel filling and SF6 tamponade.
Related Therapeutic Areas
Sponsors
Leads: Walailak University

This content was sourced from clinicaltrials.gov