Amniotic Membrane Extract Eye Drop
BiologicalAmniotic Membrane Extract use as eye drop for patients with corneal injury.
NCT Number: NCT02746848
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
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Notify Me20 year–60 year
All sexes
Interventional
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Amniotic Membrane Extract use as eye drop for patients with corneal injury.
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).
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.
Time frame: 24 hours
Evaluation of any presence of pain in treated eye after procedure based on side effect questionnaire that fill with patients.
Royan Institute
Other Gov
Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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