NCT03536715

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

November 9, 2017

Last Update Submit

May 23, 2018

Conditions

Patient-Reported Outcomes (PRO)

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

May 25, 2018

Study Start

June 1, 2016

Primary Completion

June 22, 2017

Study Completion

June 22, 2017

Last Updated

May 25, 2018

Record last verified: 2018-05