Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02746848
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2016-04-10
Brief Title:
Utilization of Amniotic Membrane Extract Eye Drop AMEED on Human Corneal Healing
Sponsor:
Royan Institute
Organization:
Royan Institute
Study Overview
Official Title:
Evaluation the Effect of Amniotic Membrane Extract Eye Drop AMEED on Human Corneal Epithelium Healing Phase I and II Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None