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

Phase 1

Completed

• Conditions: Cornea Injury
• Interventions: Biological: Amniotic Membrane Extract Eye Drop

• Registration Number: NCT02746848
• Lead Sponsor: Royan Institute

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-05
• Study Completion: 2015-11
• Status Verified: 2016-01
• Study First Submitted: 2016-04-10
• Study First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Study First Posted: 2016-04-21
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patient with corneal epithelium injury
2. Without keratoconus
3. Without cornea scar
4. Without any other lesion of cornea

Exclusion Criteria

1. Lack of timely referral of patients for examinations
2. Simultaneous use of other drugs that cause impairment of the data
3. Previous cornea surgery
4. Dry eye
5. Glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with cornea injury	Amniotic Membrane Extract Eye Drop	Patients with cornea injury who received healing Amniotic Membrane Extract Eye Drop.

Primary Outcome Measures

Name	Time	Method
corneal defect size	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).

Secondary Outcome Measures

Name	Time	Method
Eye Discharge	1 week	Evaluation the presence of any abnormal discharge from treated eye after procedure based on side effect questionnaire that fill with patients.
pain	24 hours	Evaluation of any presence of pain in treated eye after procedure based on side effect questionnaire that fill with patients.