The Effect of VOXX/eSmartr High Performance Technology on... | NCT04051138

Studies
The Effect of VOXX/eSmartr High Performance Technology on Sports Vision Ability

NCT04051138

Sponsor

ChampionsEdge, LLC

Status

Completed

Last Update Posted

Jan 27, 2021Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Vision, Binocular
Sports Medicine

Interventions

Voxx socks and sleeves

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2019Actual

Primary Completion Date

Oct 30, 2019Actual

Completion Date

Oct 30, 2019Actual

First Submitted Date

Aug 5, 2019

First Submission Date that Met QC Criteria

Aug 7, 2019

First Posted Date

Aug 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2021

Last Update Posted Date

Jan 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voxx socks and sleeves	Other	participants will be tested with a true device as well as with a placebo device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CoreScore	A measure of visual function scored on a linear scale fro +5 to -5, more positive scores are better	1 day

Secondary Outcomes

Measure	Description	Time Frame
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	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria.

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

Exclusion Criteria.

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel M Laby, MD	ChampionsEdge, LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SportsVisionNYC		New York	New York	10019	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided