Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument

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

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 Overview

• Status: Completed
• Conditions: Patient-Reported Outcomes (PRO)

• Study Type: Observational
• Enrollment (Actual): 22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRO instrument	Develop PRO instrument that will assess KAMRA inlay-related visual symptoms and to establish the content validity of that PRO instrument.	6 months

Collaborators and Investigators

• Sponsor: AcuFocus, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): June 22, 2017
• Study Completion (ACTUAL): June 22, 2017

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (ACTUAL): May 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: KAMR-201-PRO1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No