Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- corneal defect size
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with corneal epithelium injury
- •Without keratoconus
- •Without cornea scar
- •Without any other lesion of cornea
排除标准
- •Lack of timely referral of patients for examinations
- •Simultaneous use of other drugs that cause impairment of the data
- •Previous cornea surgery
结局指标
主要结局
corneal defect size
时间窗: 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).
次要结局
- Eye Discharge(1 week)
- pain(24 hours)