Vision, BinocularNCT04051138
The Effect of VOXX/eSmartr High Performance Technology on Sports Vision Ability
A study testing Voxx socks and sleeves in people with Vision, Binocular and Sports Medicine, run by ChampionsEdge, LLC at 1 site in United States.
Trial summary
This study is designed to compare the effect of Voxx/eSmartr technology on common measures of sports vision performance including (Hand-Eye Coordination/Reaction time, visual concentration and basic visual functions of size detection and contrast sensitivity). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision, Binocular, Sports Medicine
- What is being tested?
- Voxx socks and sleeves
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 30 Oct 2019
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female or Male age 18-45 years of age
- Exercises at least once a week by self-report
- Physically able to complete the HEC/RT test (e.g. no shoulder or arm discomfort or limitation
Who cannot join
- Member of a vulnerable population
- Visual or physical condition which precludes performing the physical or visual testing (e.g. strabismus, double vision, shoulder or arm pain or injury)
- Previous training in hand-eye coordination/reaction time or visual concentration
- History of double vision or strabismus
- Insufficient vision to drive an automobile in NY State
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to compare the effect of Voxx/eSmartr technology on common measures of sports vision performance including (Hand-Eye Coordination/Reaction time, visual concentration and basic visual functions of size detection and contrast sensitivity). The study will be a randomized, prospective, double-blind design in order to determine the effect of this technology on a subject's sports vision ability.
- Conditions
- Vision, Binocular, Sports Medicine
- Being tested
- Voxx socks and sleeves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voxx socks and sleevesOther
participants will be tested with a true device as well as with a placebo device
What is being measured
The primary outcome is the main question the study is designed to answer.
CoreScore
A measure of visual function scored on a linear scale fro +5 to -5, more positive scores are better
Measured: 1 day
Secondary outcomes (2)
Hand-Eye Coordination/Reaction Time
A measure of how fast the subject reacts to a visual target with their hand, scored on milliseconds, faster the better
Measured: 1 day
Neurotracker score
A measure of how correctly the subject can track multiple objects, scored from 0 to 5 with higher score being better
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start15 Aug 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision, BinocularStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized, double blind, prospective
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChampionsEdge, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel M Laby, MD, Principal investigator, ChampionsEdge, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051138
- Sponsor's protocol ID
- Voxx1
- Status last verified
- Jan 2021
- First submitted
- 5 Aug 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of VOXX/eSmartr High Performance Technology on Sports Vision Ability
- ClinicalTrials.gov ID
- NCT04051138
- Acronym / sponsor ID
- Voxx1
- Conditions
- Vision, Binocular, Sports Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ChampionsEdge, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 9 Aug 2019 (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.
This study is designed to compare the effect of Voxx/eSmartr technology on common measures of sports vision performance including (Hand-Eye Coordination/Reaction time, visual concentration and basic visual functions of size detection and contrast sensitivity). The study will be a randomized, prospective, double-blind design in order to determine the effect of this technology on a subject's sports vision ability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Model description
- randomized, double blind, prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female or Male age 18-45 years of age
- Exercises at least once a week by self-report
- Physically able to complete the HEC/RT test (e.g. no shoulder or arm discomfort or limitation
Key exclusion criteria (5 listed)
- Member of a vulnerable population
- Visual or physical condition which precludes performing the physical or visual testing (e.g. strabismus, double vision, shoulder or arm pain or injury)
- Previous training in hand-eye coordination/reaction time or visual concentration
- History of double vision or strabismus
- Insufficient vision to drive an automobile in NY State
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 |
|---|---|---|
| Voxx socks and sleevesparticipants will be tested with a true device as well as with a placebo device | Other | – |
Primary outcome
CoreScore
Time frame: 1 day
A measure of visual function scored on a linear scale fro +5 to -5, more positive scores are better
2 secondary outcomes
Hand-Eye Coordination/Reaction Time
Time frame: 1 day
Neurotracker score
Time frame: 1 day
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 27 Jan 2021.
- 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.
Daniel M Laby, MD principal investigator
ChampionsEdge, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voxx socks and sleeves in people with Vision, Binocular and Sports Medicine, run by ChampionsEdge, LLC 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 3 inclusion and 5 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 27 Jan 2021. 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?
CoreScore (time frame: 1 day). 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 27 Jan 2021.