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

• Sponsor: ChampionsEdge, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04051138
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vision, Binocular; Sports Medicine	Other: Voxx socks and sleeves	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: randomized, double blind, prospectiverandomized, double blind, prospective
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Effect of VOXX/eSmartr High Performance Technology on Sports Vision Ability
• Actual Study Start Date: Aug 15, 2019
• Actual Primary Completion Date: Oct 30, 2019
• Actual Study Completion Date: Oct 30, 2019

Outcome Measures

Primary Outcome Measures

1. CoreScore [1 day]

   A measure of visual function scored on a linear scale fro +5 to -5, more positive scores are better

Secondary Outcome Measures

1. Hand-Eye Coordination/Reaction Time [1 day]

   A measure of how fast the subject reacts to a visual target with their hand, scored on milliseconds, faster the better

2. Neurotracker score [1 day]

   A measure of how correctly the subject can track multiple objects, scored from 0 to 5 with higher score being better

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SportsVisionNYC	New York	New York	United States	10019

Sponsors and Collaborators

• ChampionsEdge, LLC

Investigators

• Principal Investigator: Daniel M Laby, MD, ChampionsEdge, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ChampionsEdge, LLC
• ClinicalTrials.gov Identifier: NCT04051138
• Other Study ID Numbers: Voxx1
• First Posted: Aug 9, 2019
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 27, 2021