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Safety and Feasibility of the EyeControl Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891629
Recruitment Status : Completed
First Posted : September 7, 2016
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Eyefree Assisting Communication Ltd

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition ALS (Amyotrophic Lateral Sclerosis)
Intervention Device: EyeControl device
Enrollment 15
Recruitment Details  
Pre-assignment Details Investigator decided to terminate subject participation due to the discovery of cataract during the trial.
Arm/Group Title Device Use in Healthy Volunteers Device Use in ALS Patients
Hide Arm/Group Description

10 healthy volunteers will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

5 ALS patients in early stages will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

Period Title: Overall Study
Started 10 5
Completed 10 4
Not Completed 0 1
Arm/Group Title Device Use in Healthy Volunteers Device Use in ALS Patients Total
Hide Arm/Group Description

10 healthy volunteers will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

5 ALS patients in early stages will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

Total of all reporting groups
Overall Number of Baseline Participants 10 4 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 4 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
4
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 4 participants 14 participants
30.3  (9.83) 46.25  (5.26) 36.6  (11.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 4 participants 14 participants
Female
5
  50.0%
0
   0.0%
5
  35.7%
Male
5
  50.0%
4
 100.0%
9
  64.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 10 participants 4 participants 14 participants
10 4 14
1.Primary Outcome
Title Feasibility - Successful Performance Rate of Device Features
Hide Description Ability to successfully perform at least 70% of device features (controlling the application and Free text features)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device Use in Healthy Volunteers Device Use in ALS Patients
Hide Arm/Group Description:

10 healthy volunteers will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

5 ALS patients in early stages will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: seconds
4.9  (1.3) 7.2  (2.2)
2.Secondary Outcome
Title Safety Assessment - Number of Device Related Adverse Events
Hide Description number of device related adverse events reported during the use of the device
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device Use in Healthy Volunteers Device Use in ALS Patients
Hide Arm/Group Description:

10 healthy volunteers will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

5 ALS patients in early stages will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

Overall Number of Participants Analyzed 10 4
Measure Type: Number
Unit of Measure: events
2 0
Time Frame The adverse events data was collected only during the trial, meaning during the 4 sessions, of about 2.5-3 hours, for each participant, performed over 2 weeks' time.
Adverse Event Reporting Description An AE can be any unintended sign, symptom, disease or injury or any untoward clinical signs (including an abnormal laboratory findings) in subjects, users or other persons whether or not related to the investigational medical device.
 
Arm/Group Title Device Use in Healthy Volunteers Device Use in ALS Patients
Hide Arm/Group Description

10 healthy volunteers will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

5 ALS patients in early stages will be recruited

EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences

All-Cause Mortality
Device Use in Healthy Volunteers Device Use in ALS Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Device Use in Healthy Volunteers Device Use in ALS Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Device Use in Healthy Volunteers Device Use in ALS Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      0/5 (0.00%)    
Eye disorders     
Dry Eyes * [1]  1/10 (10.00%)  1 /5 
Eye Fatigue * [2]  1/10 (10.00%)  1 /5 
*
Indicates events were collected by non-systematic assessment
[1]
Participant complained on dry eyes
[2]
Participant complained on eye fatigue
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Or Retzkin, CEO
Organization: EyeFree Assisting Communication
Phone: +972526490093
EMail: or@eyecontrol.co.il
Layout table for additonal information
Responsible Party: Eyefree Assisting Communication Ltd
ClinicalTrials.gov Identifier: NCT02891629    
Other Study ID Numbers: EFAC-01
First Submitted: August 29, 2016
First Posted: September 7, 2016
Results First Submitted: July 17, 2019
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019