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OpenTrials
Completed

NCT Number: NCT02746848

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

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with corneal epithelium injury
  • Without keratoconus
  • Without cornea scar
  • Without any other lesion of cornea

Exclusion criteria

  • 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

Treatment and study plan

Amniotic Membrane Extract Eye Drop

Biological

Amniotic Membrane Extract use as eye drop for patients with corneal injury.

Primary outcomes

  1. corneal defect size

    Time frame: 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 outcomes

  1. Eye Discharge

    Time frame: 1 week

    Evaluation the presence of any abnormal discharge from treated eye after procedure based on side effect questionnaire that fill with patients.

  2. pain

    Time frame: 24 hours

    Evaluation of any presence of pain in treated eye after procedure based on side effect questionnaire that fill with patients.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2016
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.