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

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 Overview

• Status: Completed
• Conditions: Vision, Binocular; Sports Medicine
• Intervention / Treatment: Other: Voxx socks and sleeves

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • SportsVisionNYC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Voxx1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No