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

Royan Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cornea Injury

Treatments: Biological: Amniotic Membrane Extract Eye Drop

Study type: Interventional

Funder types: Other

Identifiers

NCT02746848

Royan-Eye-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Patients with cornea injury

Experimental group

Description:

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

Treatment:

Biological: Amniotic Membrane Extract Eye Drop