NCT04107246已完成不适用
Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ratio between the number of instilled drops / number of prescribed drops
研究概览
简要总结
Following corneal graft, local steroids with a gradually decreasing dose for 12 months are prescribed to reduce the graft rejection risk (maximum incidence of 20% for the first 12 months). The validated KaliJAR® device is a box for single-dose eye drops collection. This innovative tool will make it possible to objectify the compliance of patients with a corneal graft.
Unlike the field of glaucoma, no specific compliance data are available for corneal grafts, although it is important because graft rejection is the most important cause of corneal graft failure.
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
- •Newly transplanted corneal patients
- •Patients able to instill correctly topical corticosteroid treatment
- •Patients able to come to control visits
- •Patient affiliated or entitled to a social security system
- •Patient informed about the study and having signed a consent
排除标准
- •Patients under guardianship
- •Patients unable to give their consent or to correctly use the collection box
结局指标
主要结局
Ratio between the number of instilled drops / number of prescribed drops
时间窗: 12 months
次要结局
- Questionnaire on therapeutic compliance(month 1, month 6 and month 12)
- patient behaviour towards corticosteroid treatment(12 months)
研究者
研究点 (1)
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