NCT03536715已完成不适用
Qualitative Patient Interviews to Develop a Patient-Reported Outcomes (PRO) Instrument to Assess Visual Symptoms in KAMRA® Inlay Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- PRO instrument
研究概览
简要总结
The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum 45 years of age, maximum age 60 years;
- •Subject has been implanted with the KAMRA inlay;
- •Subject is in good general health, as evidenced by medical history;
- •Subject is willing and able to attend and participate in the interviews and demographic questionnaire (fluent in U.S. English); and
- •Signed informed consent document.
排除标准
- •Subject has severe neurological or cognitive deficits or an uncontrolled psychiatric condition that might affect their ability to participate in the interview;
- •Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help;
- •Subject is not a fluent speaker of U.S. English; or
- •Subject is unable to attend the interview.
结局指标
主要结局
PRO instrument
时间窗: 6 months
Develop PRO instrument that will assess KAMRA inlay-related visual symptoms and to establish the content validity of that PRO instrument.
次要结局
未报告次要终点
研究者
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