NCT03536715CompletedNot Applicable
Qualitative Patient Interviews to Develop a Patient-Reported Outcomes (PRO) Instrument to Assess Visual Symptoms in KAMRA® Inlay Patients
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AcuFocus, Inc.
- Enrollment
- 22
- Primary Endpoint
- PRO instrument
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
PRO instrument
Time Frame: 6 months
Develop PRO instrument that will assess KAMRA inlay-related visual symptoms and to establish the content validity of that PRO instrument.
Secondary Outcomes
No secondary outcomes reported
Investigators
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