The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops
研究概览
简要总结
Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.
详细描述
Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be taken in multiple doses.
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
- 21 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cognitive ability to understand and sign the consent form.
- •Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment (therapeutic contact lenses, topical artificial tears, eye packs and antibiotic eye-drops).
- •Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy, corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal lesions due to a foreign body.
- •Good compliance with the study regimen and availability for the duration of the entire study period.
排除标准
- •Corneal ulcers which developed tissue scars.
- •Pregnant or lactating women.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops
时间窗: 2 months
Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops.
次要结局
- Assessment of the efficacy by clinical judgment(6 months)
研究者
Hanan Jafar
Researcher
University of Jordan