Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument
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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
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Layout table for eligibility information
Ages Eligible for Study:
45 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The sample recruited will reflect the target KAMRA inlay patient population. Thus, a minimum of 20 subjects (up to 50 subjects to achieve saturation) who have been implanted with the KAMRA inlay will be recruited from up to 5 sites across the US. Subjects with a range of post-operative experience, satisfaction, visual symptoms, ages and educational abilities will be recruited. In addition, subjects who are of non Caucasian ethnicity will be included.
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.
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