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

Launched by WALAILAK UNIVERSITY · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for large macular holes, which are gaps in the central part of the retina that can affect vision. The researchers want to compare the effectiveness of a special injectable gel made from decellularized human amniotic membrane (dAM) to a traditional surgical method called the inverted internal limiting membrane (ILM) flap. The goal is to see which method works better for closing these holes and improving vision.

To join the study, participants should be over 18 years old and have a specific type of macular hole that is larger than 400 microns but smaller than 1,500 microns in diameter. People with other serious eye conditions or previous eye surgeries (other than cataract surgery) are not eligible. If you qualify and choose to participate, you can expect to receive one of the two treatments and be monitored closely to see how well it works. This trial is important because it aims to find a more effective and less invasive way to help those suffering from vision loss due to macular holes.

Gender

ALL

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