PresbyopiaNCT03173664
Post-Approval Study With the KAMRA Inlay
An observational study of Presbyopia, run by AcuFocus, Inc..
Trial summary
KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- KAMRA Inlay
- Type of treatment
- Medical device
- How many people
- 529 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2018to Jan 2026
- 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: Phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 diopters to -0.75 diopters with less than or equal to 0.75 diopters of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 to +2.50 diopters of reading add.
Who may be able to join
- Meet the indications for use for this device;
- Do not have any of the conditions described in the contraindications in the labeling of the device;
- Are willing and able to provide informed consent;
- Are not participating in any other clinical studies during the course of the study.
Who cannot join
- Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; or
- Subject is not a fluent speaker of U.S. English.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay
KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.
Read the detailed description
This is a post-approval study of the KAMRA inlay performance and potential device-related issues in a broader population over an extended period of time after pre-market establishment of reasonable safety and effectiveness.
Study objectives include:
- Evaluate the long-term performance (effectiveness) and safety of the device;
- Evaluate real-world performance of the device in subjects treated by refractive surgeons with a range of experience levels;
- Evaluate the performance of the device in racial/ethnic subgroups representative of the population for which the device is intended.
In addition, the data from a subset of the first 105 subjects who have been enrolled in this study will be used to validate the KAMRA Inlay Patient Questionnaire (KIPQ) for the assessment of patients who have received the KAMRA inlay for the treatment of presbyopia.
- Conditions
- Presbyopia
- Being tested
- KAMRA Inlay
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAMRA InlayDevice
Unilateral implantation of the KAMRA inlay in the corneal stroma.
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Near Visual Acuity
Percentage of implanted eyes with monocular near visual acuity of 20/40 or better is greater than or equal to 75% of implanted eyes.
Measured: Five years
Secondary outcomes (1)
Best-corrected distance visual acuity
Percentage of implanted eyes with a persistent loss of two or more lines of best-corrected distance visual acuity from baseline at the subject's last study visit is less than 5%.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start31 Jul 2018 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 529 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AcuFocus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TBD TBD, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173664
- Sponsor's protocol ID
- KAMR-203-PASQ
- Status last verified
- May 2018
- First submitted
- 25 May 2017
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay
- ClinicalTrials.gov ID
- NCT03173664
- Acronym / sponsor ID
- KAMR-203-PASQ
- Conditions
- Presbyopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 529 participants (estimated)
- Lead sponsor
- AcuFocus, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 2 Jun 2017 (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.
KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.
Detailed description
This is a post-approval study of the KAMRA inlay performance and potential device-related issues in a broader population over an extended period of time after pre-market establishment of reasonable safety and effectiveness.
Study objectives include:
- Evaluate the long-term performance (effectiveness) and safety of the device;
- Evaluate real-world performance of the device in subjects treated by refractive surgeons with a range of experience levels;
- Evaluate the performance of the device in racial/ethnic subgroups representative of the population for which the device is intended.
In addition, the data from a subset of the first 105 subjects who have been enrolled in this study will be used to validate the KAMRA Inlay Patient Questionnaire (KIPQ) for the assessment of patients who have received the KAMRA inlay for the treatment of presbyopia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 diopters to -0.75 diopters with less than or equal to 0.75 diopters of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 to +2.50 diopters of reading add.
Key inclusion criteria (4 listed)
- Meet the indications for use for this device;
- Do not have any of the conditions described in the contraindications in the labeling of the device;
- Are willing and able to provide informed consent;
- Are not participating in any other clinical studies during the course of the study.
Key exclusion criteria (2 listed)
- Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; or
- Subject is not a fluent speaker of U.S. English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAMRA InlayUnilateral implantation of the KAMRA inlay in the corneal stroma. | Device | – |
Primary outcome
Monocular Near Visual Acuity
Time frame: Five years
Percentage of implanted eyes with monocular near visual acuity of 20/40 or better is greater than or equal to 75% of implanted eyes.
1 secondary outcome
Best-corrected distance visual acuity
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Individual participant dataSharing planned: No
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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.
TBD TBD, M.D. principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Srividhya Vilupuru, O.D., Ph.D (949/585-9511 ext. 182, svilupuru@acufocus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular Near Visual Acuity (time frame: Five years). 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 18 May 2018.