NCT04654455已完成不适用
Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Variation in OSDI (Ocular Surface Disease Index) score
研究概览
简要总结
LASIK is a refractive surgery technique widely used in France. Postoperatively, the classic treatment after LASIK consists of instilling drops to reduce dry eyes. REPADROP® is an innovative eye drops stimulating corneal innervation. To date no study has quantified the improvement in dry eye syndrome and thus the quality of life of patients using REPADROP®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •Planned bilateral LASIK surgery
- •Use of Repadrop as postoperative eye drops
- •Patient agreement to participate
排除标准
- •History of corneal pathology
- •History of treatment with REPADROP® or CACICOL® or NGF® (other eye drops which are no longer available on the market to date but which would also improve corneal healing)
- •Ongoing treatment with topical cyclosporine
- •Presence of punctal plugs
- •Adults who are the subject of a legal protection measure (guardianship, curators)
- •Pregnant or breastfeeding women
结局指标
主要结局
Variation in OSDI (Ocular Surface Disease Index) score
时间窗: 3 Months
Variation in OSDI (Ocular Surface Disease Index) score between 1 month and 3 months post-LASIK. The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
次要结局
未报告次要终点
研究者
研究点 (1)
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