Cornea Injury
Conditions
Keywords
cornea epithelium healing Amniotic Membrane Eye Drop
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.
Interventions
BIOLOGICALAmniotic Membrane Extract Eye Drop
Amniotic Membrane Extract use as eye drop for patients with corneal injury.
Sponsors
Royan Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed