Trial Outcomes & Findings for Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication (NCT NCT04582149)

Last Updated: 2025-09-25

Results Overview

Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Up to Day 3

Results posted on

2025-09-25

Participant Flow

Participants were recruited from Emory University Hospital in Atlanta, Georgia, USA. Participant enrollment began May 19, 2021 and all study assessments were completed by January 23, 2023.

Participant milestones

Participant milestones
Measure	EyeControl Eye-tracking Device Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EyeControl Eye-tracking Device n=30 Participants Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants
ICU Type Surgical	12 Participants n=5 Participants
ICU Type Medical	13 Participants n=5 Participants
ICU Type Neuroscience	5 Participants n=5 Participants
Sequential Organ Failure Assessment (SOFA) Score at Admission	6 score on a scale n=5 Participants
Body Mass Index (BMI)	28.7 kg/m^2 STANDARD_DEVIATION 8.5 • n=5 Participants
Experienced delirium during admission	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 3

Outcome measures

Outcome measures
Measure	EyeControl Eye-tracking Device n=30 Participants Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.	Did Not Pass Proficiency Test Study participants who did not pass the proficiency test for successfully operating the EyeControl device.
Number of Participants Who Succeeded in Operating the EyeControl Device	11 Participants	—

PRIMARY outcome

Timeframe: Up to Day 3

Population: The population in this analysis includes the 11 participants who were able to successfully operate the device.

Outcome measures

Outcome measures
Measure	EyeControl Eye-tracking Device n=11 Participants Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.	Did Not Pass Proficiency Test Study participants who did not pass the proficiency test for successfully operating the EyeControl device.
Time To Successful Operation of the EyeControl Device	11 minutes Standard Deviation 3	—

PRIMARY outcome

Timeframe: Up to Day 3

Population: The population in this analysis includes the 11 participants who were able to successfully operate the device.

Outcome measures

Outcome measures
Measure	EyeControl Eye-tracking Device n=11 Participants Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.	Did Not Pass Proficiency Test Study participants who did not pass the proficiency test for successfully operating the EyeControl device.
Number of Participants Successfully Operating the EyeControl Device Per Attempt Day Day 1	8 Participants	—
Number of Participants Successfully Operating the EyeControl Device Per Attempt Day Day 2	3 Participants	—
Number of Participants Successfully Operating the EyeControl Device Per Attempt Day Day 3	0 Participants	—

SECONDARY outcome

Timeframe: Up to end of study participation (up to 3 days)

The duration of EyeControl device use and participation in the trial was recorded in days (participation in the trial ended when use of the device ended). Participants left the trial due to inability to operate the device, patient request, technical issues, and no longer needing the device (extubation, ICU discharge).

Outcome measures

Outcome measures
Measure	EyeControl Eye-tracking Device n=30 Participants Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.	Did Not Pass Proficiency Test Study participants who did not pass the proficiency test for successfully operating the EyeControl device.
Days of Use	1 days Interval 1.0 to 3.0	—

POST_HOC outcome

Timeframe: Up to Day 3

Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. Clinical characteristics (tracheostomy, delirium, and exposure to certain medications) of these groups of participants were examined.

Outcome measures

Outcome measures
Measure	EyeControl Eye-tracking Device n=11 Participants Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.	Did Not Pass Proficiency Test n=19 Participants Study participants who did not pass the proficiency test for successfully operating the EyeControl device.
Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test Tracheostomy	3 Participants	8 Participants
Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test Delirium detected on day of device use	1 Participants	3 Participants
Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test Exposure to fentanyl on day of attempt to use device	2 Participants	6 Participants
Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test Exposure to any benzodiazepine on day of attempt to use device	0 Participants	1 Participants
Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test Exposure to dexmedetomidine on day of attempt to use device	6 Participants	7 Participants
Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test Exposure to propofol on day of attempt to use device	0 Participants	2 Participants
Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test Exposure to any pressors on day of attempt to use device	4 Participants	3 Participants

POST_HOC outcome

Timeframe: Up to Day 3

Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. The Sequential Organ Failure Assessment (SOFA) Score at admission of these groups of participants was compared. The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). Each organ system is scored on a 5-point scale where normal = 0 and high degree of disfunction = 4. The total score ranges from 0 to 24 and a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate.

Outcome measures

Outcome measures
Measure	EyeControl Eye-tracking Device n=11 Participants Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.	Did Not Pass Proficiency Test n=19 Participants Study participants who did not pass the proficiency test for successfully operating the EyeControl device.
SOFA Score of Participants Who Passed or Did Not Pass The Proficiency Test	7 score on a scale Interval 0.0 to 15.0	4 score on a scale Interval 0.0 to 15.0

POST_HOC outcome

Timeframe: Up to Day 3

Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. The mean age at admission of these groups of participants was compared.

Outcome measures

Outcome measures
Measure	EyeControl Eye-tracking Device n=11 Participants Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.	Did Not Pass Proficiency Test n=19 Participants Study participants who did not pass the proficiency test for successfully operating the EyeControl device.
Age of Participants Who Passed or Did Not Pass The Proficiency Test	51.9 years Standard Deviation 15.2	50.4 years Standard Deviation 14.8

Adverse Events

EyeControl Eye-tracking Device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EyeControl Eye-tracking Device n=30 participants at risk Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.
Skin and subcutaneous tissue disorders Transient redness of the skin where device touches the skin	3.3% 1/30 • Information on adverse events was collected beginning at the time patients gave consent to participate and continued up to extubation, ICU discharge, or when the participant wanted to stop using the device (up to 3 days). Adverse events that were potentially related to study activities were collected.

Additional Information

Ofer Sadan, MD, PhD

Emory University

Phone: 470-480-6956

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place