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Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536715
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Patient-Reported Outcomes (PRO)

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Qualitative Patient Interviews to Develop a Patient-Reported Outcomes (PRO) Instrument to Assess Visual Symptoms in KAMRA® Inlay Patients
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : June 22, 2017
Actual Study Completion Date : June 22, 2017



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
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Responsible Party: AcuFocus, Inc.
ClinicalTrials.gov Identifier: NCT03536715    
Other Study ID Numbers: KAMR-201-PRO1
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No