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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03536715

Enrollment

Registered

2018-05-25

Start date

2016-06-01

Completion date

2017-06-22

Last updated

2018-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient-Reported Outcomes (PRO)

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results