Qualitative Patient Interviews to Develop a Patient-Reported Outcomes (PRO) Instrument to Assess Visual Symptoms in KAMRA® Inlay Patients

AcuFocus, Inc.0 个研究点目标入组 22 人开始时间: 2016年6月1日最近更新: 2018年5月25日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: AcuFocus, Inc.
入组人数: 22
主要终点: PRO instrument

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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

发起方

AcuFocus, Inc.

申办方类型

Industry

责任方

Sponsor

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