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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with cornea injury | Experimental | Patients with cornea injury who received healing Amniotic Membrane Extract Eye Drop. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotic Membrane Extract Eye Drop | Biological | Amniotic Membrane Extract use as eye drop for patients with corneal injury. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| 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 | Study Director |
| Fatemeh Doostmohammadi, MD | Bina Hospital, Research & Education Center, Tehran, Iran | Principal Investigator |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D065306 | Corneal Injuries |
| ID | Term |
|---|---|
| D005131 | Eye Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| 24 hours |
| D009422 |
| Nervous System Diseases |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |