Utilization of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Healing
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|ClinicalTrials.gov Identifier: NCT02746848|
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : April 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cornea Injury||Biological: Amniotic Membrane Extract Eye Drop||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Patients with cornea injury
Patients with cornea injury who received healing Amniotic Membrane Extract Eye Drop.
Biological: Amniotic Membrane Extract Eye Drop
Amniotic Membrane Extract use as eye drop for patients with corneal injury.
- corneal defect size [ Time Frame: 12 months ]Evaluation the corneal defect size (millimeter) by microscope after corneal surgery and compare the change of defect size after procedure in compare with base line (before surgery).
- Eye Discharge [ Time Frame: 1 week ]Evaluation the presence of any abnormal discharge from treated eye after procedure based on side effect questionnaire that fill with patients.
- pain [ Time Frame: 24 hours ]Evaluation of any presence of pain in treated eye after procedure based on side effect questionnaire that fill with patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746848
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||Marzieh Ebrahimi, PhD||Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.|
|Study Director:||Khosro Jadidi, MD||Bina Hospital, Research & Education Center, Tehran, Iran|
|Principal Investigator:||Fatemeh Doostmohammadi, MD||Bina Hospital, Research & Education Center, Tehran, Iran|