A Prospective Interventional Non-randomized and Non-comparative Series of Cases of Patiens Suffering Ocular Surface Syndrome Post-LASIK: Outcomes After the Treatment With Platelet Rich Plasma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Corneal fluorescein staining (CFS)
研究概览
简要总结
To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis (LASIK).
详细描述
Prospective interventional consecutive case series including 156 eyes of 80 patients affected by chronic post-LASIK OSS who were treated with autologous E-PRP 6 times a day as monotherapy for 6 weeks. Assessment after treatment with E-PRP included: dry eye symptoms, change in corrected distance visual acuity (CDVA), corneal fluorescein staining (CFS) and conjunctival hyperemia.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients suffering from moderate to severe dry eye syndrome for 6 months or more after conventional treatments with artificial tears following LASIK.
- •Tear break-up time (TBUT) between 4 and 9 seconds.
排除标准
- •Ocular pathology needing topical treatments different than dry eye syndrome
- •Trombocitopeny, associated pathologies to coagulation factors or any state of plaquets antiagregation (AAS and other AINES).
- •Ocular tumours, corneal distrophies, history of ocular herpes.
- •Pregnant or nursering women.
结局指标
主要结局
Corneal fluorescein staining (CFS)
时间窗: Before LASIK surgery and after the 6 weeks of treatment
Staining using fluorescein will be graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 (see Appendix 2). On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represents complete corneal clearing. A negative change from baseline will indicate improvement.
次要结局
- Conjunctival hyperemia(Before LASIK surgery and after the 6 weeks of treatment)
- Corrected distance visual acuity (CDVA)(Before LASIK surgery and after the 6 weeks of treatment)
- Dry eye symptoms(Before LASIK surgery and after the 6 weeks of treatment)