Cornea Injury Clinical Trial
Official title:
Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)
For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal surgery and others, it is important that short time treatment with minimal side effect should be considered. This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing
The cornea is the specific anterior part of eye that is essential for normal vision. The
corneal surface is comprised of a unique type of non-keratinized epithelial cell. Corneal
epithelium contains transient amplifying cells and post mitotic cells. The limbal stem cells
(LSC) are located between limbal cornea and conjunctiva which are main source of corneal
epithelium healing in eye injuries. For some corneal disease such as chemical and thermal
injuries, Corneal Dystrophies and corneal surgery, treatment in short time is important.
AM can modulate corneal epithelium healing by promoting re-epithelialization and migration
of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. This
biological substrate maintain epithelial progenitor cells within the limbal stem cell niche
and facilitate ocular surface epithelial renewal. It is well accepted that amniotic membrane
Transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent
reapplication of membrane is difficult for the patient.
Other studies have been reported that processed AM as a liquid has comparable effect to AMT
in treatment of corneal epithelial healing.
This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED)
as a natural substance for acceleration of corneal healing.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04439552 -
fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
|