Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Staining
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.
详细描述
A group of selected dry eye patients from the Singapore National Eye Centre who have exhausted the usual treatment options (lubricants, topical immunosuppressive and punctal occlusion) and not keen for tarsorrhaphy will be recruited. After informed consent, they will undergo plasmapheresis and start on daily autologous serum eyedrops for a period of 4 months. Clinical monitoring for standard dry eye parameters such as punctate corneal keratitis, Schirmers testing, tear break up time as well as severity and frequency of dry eye symptoms will be conducted. Tear inflammatory proteins captured on Schirmers paper pre and post treatment will be analysed as well.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seen at the dry eye service at the Singapore National Eye Centre
- •Age between 21 and 75 years old
- •Symptomatic for dry eye or VA worse than 6/12 in Snellen chart
- •Presence of corneal punctate staining involving central zone
- •Exhausted what is considered as standard therapy or therapy that is acceptable to the patient and the physician
- •No contraindication for blood extraction/plasmapheresis
排除标准
- •HIV/HCV/HBV/syphilis
研究组 & 干预措施
Serum eye drops
Patient's autologous serum is diluted in saline solution
干预措施: Autologous serum eyedrops (Drug)
结局指标
主要结局
Staining
时间窗: 4 months
Grading of punctate corneal staining in the worse eye (second visit relative to first visit)
次要结局
- Conjunctiva(4 months)
- Tear-production(4 months)
- Tear-stability(4 months)
- Symptoms(4 months)
- Tear-proteins(4 months)
- Cornea(4 months)
研究者
Louis Tong
Clinician-Scientist
Singapore National Eye Centre