Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument

Completed

• Conditions: Patient-Reported Outcomes (PRO)

• Registration Number: NCT03536715
• Lead Sponsor: AcuFocus, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-06-22
• Study Completion: 2017-06-22
• Study First Submitted: 2017-11-09
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-23
• Last Update Submitted: 2018-05-23
• Study First Posted: 2018-05-25
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Minimum 45 years of age, maximum age 60 years;
2. Subject has been implanted with the KAMRA inlay;
3. Subject is in good general health, as evidenced by medical history;
4. Subject is willing and able to attend and participate in the interviews and demographic questionnaire (fluent in U.S. English); and
5. Signed informed consent document.

Exclusion Criteria

1. Subject has severe neurological or cognitive deficits or an uncontrolled psychiatric condition that might affect their ability to participate in the interview;
2. Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help;
3. Subject is not a fluent speaker of U.S. English; or
4. Subject is unable to attend the interview.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRO instrument	6 months	Develop PRO instrument that will assess KAMRA inlay-related visual symptoms and to establish the content validity of that PRO instrument.