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Completed

NCT Number: NCT03536715

Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument

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

Completed

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Key information

Conditions

Patient-Reported Outcomes (PRO)

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

AcuFocus, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 25, 2018
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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