Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 8
- 主要终点
- validation of our eye rubbing questionnaire
研究概览
简要总结
KC is a degenerative disorder of the cornea. Keratoconus etiopathogenesis remains unclear and may rely on environmental and genetic factors. Usually considered as a rare disease (<1/2000), but the prevalence is nowadays growing worldwide up to 1/500. In that pathology, cornea progressively gets thinner, and there is a deformation of the corneal surface which can induce high order optical aberrations and visual impairment.
Eye rubbing is certainly the main factor in the progression or development of keratoconus (KC), yet it is only very partially evaluated and quantified in current management. Environmental and clinical factors will be collected and associated with a eye rubbing Questionnaire, specifically pointing out eye rubbing.
详细描述
CNRK center is working on an eye rubbing questionnaire since 2017 in order to quantify that pejorative factor. Patient education can limit in a certain amount the Keratoconus progression. Thus, our objective will be to evaluate the therapeutic impact on Keratoconus progression of patient's education against eye rubbing according to an eye rubbing Questionnaire.
The validation of a dedicated questionnaire is an important act that will allow the scientific evaluation of this factor with both environmental and behavioral traits. It can thus be integrated into our care activity for its intrinsic educational and therapeutic virtues and for its decision-making aid for certain treatments. It will be useful first of all for the refinement of the correct prescription of corneal collagen crosslinking for evolving KC or KC with a high risk of progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coming for the first time for expert advice on KC
- •Having a suspected or known KC
- •Being over 13 years old (or from 13 years old)
- •Possess computer connection equipment (computer, tablet or smartphone) and access to the network, for the completion of the questionnaire at home.
- •Being affiliated to or beneficiary of health insurance
- •Have signed the informed consent form from the patient and from legal representatives for minor patient
排除标准
- •Being incapacitated or unable to follow study procedures
- •Patient under legal protection
- •Previous ocular surgery
研究组 & 干预措施
exploratory phase
eye rubbing questionnaire at baseline and 15 days later
干预措施: eye rubbing questionnaire (Other)
结局指标
主要结局
validation of our eye rubbing questionnaire
时间窗: Baseline and 15 days after (Day 15)
validation of our eye rubbing questionnaire will be made through the evaluation of its Suitability (Appearance validity, Content validity), Reliability (Consistency and homogeneity, Reproducibility), Applicability (Feasibility and acceptability), Validity (Construct validity), Sensitivity (Sensitivity to change, Discriminative validity)
次要结局
- questionnaire simplification(Month 6)
- Expert consensus by nominal group(Month 6)