NCT04051138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

August 5, 2019

Last Update Submit

January 25, 2021

Conditions

Vision, BinocularSports Medicine

Outcome Measures

Primary Outcomes (1)

  • CoreScore

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

    1 day

Secondary Outcomes (2)

  • Hand-Eye Coordination/Reaction Time

    1 day

  • Neurotracker score

    1 day

Interventions

Voxx socks and sleevesOTHER

participants will be tested with a true device as well as with a placebo device

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SportsVisionNYC

New York, New York, 10019, United States

Location

Study Officials

  • Daniel M Laby, MD

    ChampionsEdge, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: randomized, double blind, prospective
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 9, 2019

Study Start

August 15, 2019

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)