Utilization of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Healing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)

Conditions
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Cornea Injury

Intervention / Treatment
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* Biological: Amniotic Membrane Extract Eye Drop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with corneal epithelium injury Without keratoconus Without cornea scar Without any other lesion of cornea Exclusion Criteria: Lack of timely referral of patients for examinations Simultaneous use of other drugs that cause impairment of the data Previous cornea surgery Dry eye Glaucoma

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with cornea injury<br>Patients with cornea injury who received healing Amniotic Membrane Extract Eye Drop. | Biological: Amniotic Membrane Extract Eye Drop<br>* Amniotic Membrane Extract use as eye drop for patients with corneal injury.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal defect size | 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye Discharge | Evaluation the presence of any abnormal discharge from treated eye after procedure based on side effect questionnaire that fill with patients. | 1 week | 
| pain | Evaluation of any presence of pain in treated eye after procedure based on side effect questionnaire that fill with patients. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cornea epithelium healing Amniotic Membrane Eye Drop