Trial Outcomes & Findings for EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1 (NCT NCT02844543)

Results Overview

The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Phase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

155 participants

Primary outcome timeframe

Up to 6 hours

Results posted on

2018-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Athletes Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
Overall Study STARTED	155
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Athletes Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
Overall Study Withdrawal by Subject	4
Overall Study Did not meet eligibility criteria	1

Baseline Characteristics

EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Athletes n=150 Participants Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
Age, Continuous	19.8 years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 hours

Population: Participants with evaluable data at the respective time point were included in the analysis.

The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Phase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

Outcome measures

Outcome measures
Measure	Athletes n=155 Participants Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error Prior to practice/game	-0.6 Degrees Standard Deviation 4.0
Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error After practice/game	-0.8 Degrees Standard Deviation 0.5

PRIMARY outcome

Timeframe: Up to 6 hours

Population: Participants with evaluable data at the respective time point were included in the analysis.

The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Tangential and radial error are defined as degrees of variation in eye tracking along a circular path (tangential) and at 90 degrees to the tangential path (radial). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

Outcome measures

Outcome measures
Measure	Athletes n=155 Participants Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error Tangential: prior to practice/game	1.2 Degrees of variation Standard Deviation 0.8
Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error Tangential: after practice/game	1.1 Degrees of variation Standard Deviation 0.7
Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error Radial: prior to practice/game	0.9 Degrees of variation Standard Deviation 0.4
Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error Radial: after practice/game	0.8 Degrees of variation Standard Deviation 0.5

PRIMARY outcome

Timeframe: Up to 6 hours

Population: Participants with evaluable data at the respective time point were included in the analysis.

The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Vertical and horizontal gain are defined as the ratio of velocity (velocity of the eye:velocity of the target). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

Outcome measures

Outcome measures
Measure	Athletes n=155 Participants Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain Horizontal: prior to practice/game	0.9 Ratio of velocity (degrees per second) Standard Deviation 0.1
Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain Horizontal: after practice/game	0.9 Ratio of velocity (degrees per second) Standard Deviation 0.1
Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain Vertical: prior to practice/game	0.8 Ratio of velocity (degrees per second) Standard Deviation 0.1
Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain Vertical: after practice/game	0.8 Ratio of velocity (degrees per second) Standard Deviation 0.1

SECONDARY outcome

Timeframe: Day of study/event (up to 6 hours)

Population: Participants who completed the protocol were included in the analysis.

Change in SCAT-3 SAC score before and after practice or game is reported. The SAC score is based on the following assessments: number of symptoms (22 points), symptom severity (132 points), orientation (5 points), immediate memory (15 points), concentration (5 points), and delayed recall (5 points). Scores are summed for a possible range of 0 to 184, with lower scores corresponding to fewer concussion symptoms, and higher scores corresponding to more concussion symptoms.

Outcome measures

Outcome measures
Measure	Athletes n=150 Participants Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest.
Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score	-0.6 units on a scale Standard Deviation 3.6

Adverse Events

Athletes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jamshid Ghajar, MD, PhD

Stanford University

Phone: (650) 725-5562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place