Trial Outcomes & Findings for Visual Enhancement Device in Low Vision Patients (NCT NCT03794752)

Results Overview

ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device. The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

5 minutes post intervention

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Use of Head Mounted Device Evergaze has developed a head-mounted visual enhancement device for low-vision patients. Patients will be non-randomized individuals diagnosed with either Retinal Degeneration or diabetic macular edema with ETDRS (Early Treatment Diabetic Retinopathy Study) VA 20/60 to 20/400. The device will be placed over the most degraded eye incorporating a camera, mounted coaxially with the visual axis of the eye with the worse vision. Incorporation of a video recording of head and eye movement with the head mounted device is being included for any functionality improvements to be made. Then each subject will undergo complete examination of their eyes, including ETDRS VA, distance and near along with Questions 5,6,7,and 11 of the NEI (National Eye Institute) 25 item visual function questionnaire (NEI VFQ 25)
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rows represent Race and Ethnicity.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vision Aided by a Head Mounted Device n=8 Participants Head-Mounted Visual Enhancement Device: Evergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black \& white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use).
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants
Age, Categorical >=65 years	8 Participants n=39 Participants
Sex: Female, Male Female	7 Participants n=39 Participants
Sex: Female, Male Male	1 Participants n=39 Participants
Race/Ethnicity, Customized Black	1 Participants n=39 Participants • Rows represent Race and Ethnicity.
Race/Ethnicity, Customized White/Hispanic	1 Participants n=39 Participants • Rows represent Race and Ethnicity.
Race/Ethnicity, Customized White/Non-HIspanic	6 Participants n=39 Participants • Rows represent Race and Ethnicity.

PRIMARY outcome

Timeframe: 5 minutes post intervention

ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device. The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.

Outcome measures

Outcome measures
Measure	Vision Aided by a Head Mounted Device n=8 Participants ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected visual acuity (BCVA) will be determined for each participant using the following conditions. 1\. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device.
Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device BCVA unable to read	1 Participants
Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device BCVA </= 20/50	4 Participants
Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device BCVA </= 20/80	2 Participants
Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device BCVA > 20/350	1 Participants

PRIMARY outcome

Timeframe: 10 minutes post intervention

ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.

Outcome measures

Outcome measures
Measure	Vision Aided by a Head Mounted Device n=8 Participants ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected visual acuity (BCVA) will be determined for each participant using the following conditions. 1\. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device.
Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device BCVNA Unable to read	1 Participants
Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device BCVNA <=20/50	2 Participants
Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device BCVNA <=20/150	1 Participants
Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device BCVNA > 20/150	4 Participants

PRIMARY outcome

Timeframe: Day 1 up to 6 minutes post intervention

Population: Participants were asked to read a passage 98 words within a 3 min. time period

Reading completion with head-mounted electronic visual enhancement device was measured by reading a standard paragraph from 3-Minute Reading Assessments by Rasinski TV and Padak N, 2005. Scholastic Inc., NY.

Outcome measures

Outcome measures
Measure	Vision Aided by a Head Mounted Device n=8 Participants ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected visual acuity (BCVA) will be determined for each participant using the following conditions. 1\. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device.
Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device Completed reading assignment with device	4 Participants
Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device Did not complete reading assignment with device	4 Participants

PRIMARY outcome

Timeframe: Day 1 up to 1 minute post intervention

Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions using the head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.

Outcome measures

Outcome measures
Measure	Vision Aided by a Head Mounted Device n=8 Participants ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected visual acuity (BCVA) will be determined for each participant using the following conditions. 1\. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device.
Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device. Able to distinguish expressions w/ device	4 Participants
Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device. Unable to distinguish expressions w/ device	4 Participants

PRIMARY outcome

Timeframe: Initial Baseline and 3 minutes

Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded with the head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.

Outcome measures

Outcome measures
Measure	Vision Aided by a Head Mounted Device n=8 Participants ETDRS chart will be used to assess best corrected visual acuity. Change in best corrected visual acuity (BCVA) will be determined for each participant using the following conditions. 1\. The baseline with the participant not using head-mounted electronic visual enhancement device. 2. the outcome with the participant using head-mounted electronic visual enhancement device.
Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device Identify items with device < 15 sec w/ headset	3 Participants
Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device Identify items with device > 15 sec w/ headset	3 Participants
Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device Cannot identify items w/ headset	2 Participants

Adverse Events

Use of Head Mounted Device

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

Peter Chen

UT Southwestern Medical Center

Phone: 12146283837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place