HealthyNCT05222022
Engineering Evaluation of an Eye Movement Monitor Device
A study testing Retitrack in people with Healthy, run by C. Light Technologies, Inc. at 1 site in United States.
Trial summary
The objective of the engineering evaluation is to verify and validate the design of an eye movement monitor device, the Retitrack, for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses in human eyes when viewing a visual stimulus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Retitrack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2022to 10 Oct 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of good health
- Willing to participate in testing over 1 to 2 days with rest periods
- Willing to participate in device testing involving viewing visual targets, moving eyes as directed, and holding head steady
- Willing to have retinal images recorded for eye movement measurements
Who cannot join
- Refractive correction with glasses or contact lenses of more than 12 diopters of myopia or 4 diopters of hyperopia in either eye
- Active eye disease in either eye
- History of ocular surgery or ocular trauma in either eye within the past three months
- Ocular conditions in either eye that could interfere with obtaining a clear retinal image
- Ocular conditions in either eye that could affect the ability to view a stimulus or limit eye movement
- Neurological conditions that could affect eye movements
Trial locations and contacts
1 site in 1 country.
United States1 site
Blur Product Development
Cary, North Carolina, 27513
About this study
The objective of the engineering evaluation is to verify and validate the design of an eye movement monitor device, the Retitrack, for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses in human eyes when viewing a visual stimulus.
This engineering evaluation is not an applicable clinical trial. This is a design validation of the mechanism of action of the device to measure eye movement. This is not a clinical trial to evaluate the effect of an intervention on biomedical or other health-related outcomes.
Read the detailed description
This non-significant risk device evaluation involves obtaining retinal images and eye movement measurements with the Retitrack device for purposes of design verification and validation testing. These measurements are not intended for use in diagnosing, preventing, monitoring, or alleviating a medical condition. This evaluation is not intended to assess biomedical or other health-related outcomes.
The evaluation involves the voluntary participation of up to 40 healthy adults who participate in a single device testing visit conducted over one or two days. The Retitrack is used to assess the alignment of the eye for image capture, the ability to measure and analyze eye movements for fixational and visually guided saccadic responses, and the usability of the device.
- Conditions
- Healthy
- Being tested
- Retitrack
- Keywords
- Eye movement measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetitrackDevice
Retitrack device measures and analyzes eye movement
| Study group | Role | What they receive |
|---|---|---|
| Design validation of mechanism of action of an eye movement measurement device | Experimental | Participants have retinal images captured with the Retitrack device to measure eye movements. The eye movement measurements are intended to validate the mechanism of action of the device. Receives: Device: Retitrack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device measurement of involuntary fixational microsaccade amplitude
Microsaccade amplitude (in degrees)
Measured: 1 day (Single timepoint)
Device measurement of involuntary fixational microsaccade velocity
Microsaccade velocity (in degrees/second)
Measured: 1 day (Single timepoint)
Device measurement of visually guided horizontal saccade amplitude
Horizontal saccade amplitude (in degrees)
Measured: 1 day (Single timepoint)
Device measurement of visually guided horizontal saccade velocity
Horizontal saccade velocity (in degrees/second)
Measured: 1 day (Single timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start18 Feb 2022
- Primary completion31 May 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects participated in a design validation to evaluate the mechanism of action of the device to measure eye movement. This is not an applicable clinical trial to evaluate the effect of an intervention on biomedical or other health-related outcomes.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. Light Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Theis, OD, Principal investigator, Concussion Care Centre of Virginia, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222022
- Sponsor's protocol ID
- CLRT-001
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2022
- Last updated
- 23 Feb 2024
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engineering Evaluation of an Eye Movement Monitor Device
- ClinicalTrials.gov ID
- NCT05222022
- Acronym / sponsor ID
- CLRT-001
- Conditions
- Healthy
- Keywords
- Eye movement measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- C. Light Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 3 Feb 2022 (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 objective of the engineering evaluation is to verify and validate the design of an eye movement monitor device, the Retitrack, for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses in human eyes when viewing a visual stimulus.
This engineering evaluation is not an applicable clinical trial. This is a design validation of the mechanism of action of the device to measure eye movement. This is not a clinical trial to evaluate the effect of an intervention on biomedical or other health-related outcomes.
Detailed description
This non-significant risk device evaluation involves obtaining retinal images and eye movement measurements with the Retitrack device for purposes of design verification and validation testing. These measurements are not intended for use in diagnosing, preventing, monitoring, or alleviating a medical condition. This evaluation is not intended to assess biomedical or other health-related outcomes.
The evaluation involves the voluntary participation of up to 40 healthy adults who participate in a single device testing visit conducted over one or two days. The Retitrack is used to assess the alignment of the eye for image capture, the ability to measure and analyze eye movements for fixational and visually guided saccadic responses, and the usability of the device.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects participated in a design validation to evaluate the mechanism of action of the device to measure eye movement. This is not an applicable clinical trial to evaluate the effect of an intervention on biomedical or other health-related outcomes.
| Arm | Type | Receives |
|---|---|---|
| Design validation of mechanism of action of an eye movement measurement device | Experimental | Device: RetitrackParticipants have retinal images captured with the Retitrack device to measure eye movements. The eye movement measurements are intended to validate the mechanism of action of the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of good health
- Willing to participate in testing over 1 to 2 days with rest periods
- Willing to participate in device testing involving viewing visual targets, moving eyes as directed, and holding head steady
- Willing to have retinal images recorded for eye movement measurements
Key exclusion criteria (6 listed)
- Refractive correction with glasses or contact lenses of more than 12 diopters of myopia or 4 diopters of hyperopia in either eye
- Active eye disease in either eye
- History of ocular surgery or ocular trauma in either eye within the past three months
- Ocular conditions in either eye that could interfere with obtaining a clear retinal image
- Ocular conditions in either eye that could affect the ability to view a stimulus or limit eye movement
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 |
|---|---|---|
| RetitrackRetitrack device measures and analyzes eye movement | Device | Design validation of mechanism of action of an eye movement measurement device |
Primary outcome
Device measurement of involuntary fixational microsaccade amplitude
Time frame: 1 day (Single timepoint)
Microsaccade amplitude (in degrees)
Device measurement of involuntary fixational microsaccade velocity
Time frame: 1 day (Single timepoint)
Microsaccade velocity (in degrees/second)
Device measurement of visually guided horizontal saccade amplitude
Time frame: 1 day (Single timepoint)
Horizontal saccade amplitude (in degrees)
Device measurement of visually guided horizontal saccade velocity
Time frame: 1 day (Single timepoint)
Horizontal saccade velocity (in degrees/second)
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 23 Feb 2024.
- 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.
Jacqueline Theis, OD principal investigator
Concussion Care Centre of Virginia, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retitrack in people with Healthy, run by C. Light Technologies, Inc. at 1 site in United States.
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 6 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Device measurement of involuntary fixational microsaccade amplitude (time frame: 1 day (Single timepoint)). The study lists 4 primary outcomes in all. 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 23 Feb 2024.