Patient-Reported Outcomes (PRO)NCT03536715
Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument
An observational study of Patient-Reported Outcomes (PRO), run by AcuFocus, Inc..
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient-Reported Outcomes (PRO)
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 22 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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
- Conditions
- Patient-Reported Outcomes (PRO)
What is being measured
The primary outcome is the main question the study is designed to answer.
PRO instrument
Develop PRO instrument that will assess KAMRA inlay-related visual symptoms and to establish the content validity of that PRO instrument.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Jun 2016
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient-Reported Outcomes (PRO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AcuFocus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536715
- Sponsor's protocol ID
- KAMR-201-PRO1
- Status last verified
- May 2018
- First submitted
- 9 Nov 2017
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Patient Interviews to Develop a Patient-Reported Outcomes (PRO) Instrument to Assess Visual Symptoms in KAMRA® Inlay Patients
- ClinicalTrials.gov ID
- NCT03536715
- Acronym / sponsor ID
- KAMR-201-PRO1
- Conditions
- Patient-Reported Outcomes (PRO)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AcuFocus, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient-Reported Outcomes (PRO), run by AcuFocus, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRO instrument (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.