Utilization of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Healing
Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)
1 other identifier
interventional
20
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 10, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2016
CompletedApril 21, 2016
January 1, 2016
11 months
April 10, 2016
April 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Eye Discharge
1 week
pain
24 hours
Study Arms (1)
Patients with cornea injury
EXPERIMENTALPatients with cornea injury who received healing Amniotic Membrane Extract Eye Drop.
Interventions
Amniotic Membrane Extract use as eye drop for patients with corneal injury.
Eligibility Criteria
You may qualify if:
- Patient with corneal epithelium injury
- Without keratoconus
- Without cornea scar
- Without any other lesion of cornea
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2016
First Posted
April 21, 2016
Study Start
June 1, 2014
Primary Completion
May 1, 2015
Study Completion
November 1, 2015
Last Updated
April 21, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share