Study Comparing Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap for Treating Large Idiopathic Macular Holes

What this Trial Is About

This research investigates idiopathic large macular holes, a retinal condition where a defect forms in the central part of the retina, affecting vision. The study compares two surgical approaches to improve closure in large macular holes greater than 400 microns, focusing on a new injectable decellularized human amniotic membrane dAM hydrogel versus the established inverted internal limiting membrane ILM flap technique. Large macular holes tend to have lower closure rates with standard treatments, prompting exploration of these advanced surgical options. Participants undergo one of two procedures during a 25-gauge pars plana vitrectomy surgery either the inverted ILM flap technique, which creates multiple small flaps of ILM tissue placed over the hole, or complete ILM peeling followed by filling the hole with the dAM hydrogel. Both groups receive sulfur hexafluoride SF6 gas tamponade to support healing. The dAM hydrogel is a novel approach designed to be injectable and minimally invasive, potentially overcoming limitations of traditional amniotic membrane patches. During the study, participants will have their best corrected visual acuity and macular hole closure rates evaluated at six months after surgery. Safety and effectiveness are monitored through clinical examinations and imaging, with the aim to assess anatomical and visual outcomes. The trial is randomized and single-blinded, ensuring unbiased comparison, and is conducted under ethical approval with rigorous laboratory testing of the dAM hydrogel before use.

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