Clinical trial NCT02746848: Utilization of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Healing
Official title: Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cornea Injury
Keywords: cornea epithelium healing Amniotic Membrane Eye Drop
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2016-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: corneal defect size
timeFrame: 12 months
Secondary outcomes:
measure: Eye Discharge
timeFrame: 1 week
measure: pain
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
name: Marzieh Ebrahimi, PhD
role: STUDY_DIRECTOR
affiliation: Bina Hospital, Research & Education Center, Tehran, Iran
name: Khosro Jadidi, MD
role: STUDY_DIRECTOR
affiliation: Bina Hospital, Research & Education Center, Tehran, Iran
name: Fatemeh Doostmohammadi, MD
role: PRINCIPAL_INVESTIGATOR
References: