Trial Outcomes & Findings for Optical Head-Mounted Display Technology for Low Vision Rehabilitation (NCT NCT02983305)

NCT ID: NCT02983305

Last Updated: 2019-10-09

Results Overview

Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision. Average of both eyes visual fields with intervention.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Baseline and two to four weeks
• Results posted on: 2019-10-09

Participant Flow

Participant milestones

Measure	Retinal Dystrophy Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.	Healthy Age-Matched Controls Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.
Overall Study STARTED	12	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Retinal Dystrophy Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.	Healthy Age-Matched Controls Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.
Overall Study incomplete data	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Retinal Dystrophy n=10 Participants Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.	Healthy Age-Matched Controls n=10 Participants Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.	Total n=20 Participants Total of all reporting groups
Age, Continuous	33.5 years n=10 Participants	33 years n=10 Participants	33.5 years n=20 Participants
Sex: Female, Male Female	5 Participants n=10 Participants	5 Participants n=10 Participants	10 Participants n=20 Participants
Sex: Female, Male Male	5 Participants n=10 Participants	5 Participants n=10 Participants	10 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Visual Field Area	568.96 degrees^2 n=10 Participants	19280.09 degrees^2 n=10 Participants	19009.42 degrees^2 n=20 Participants
Gait Speed	1.27 meters per second n=10 Participants	1.25 meters per second n=10 Participants	1.26 meters per second n=20 Participants

PRIMARY outcome

Timeframe: Baseline and two to four weeks

Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision.

Average of both eyes visual fields with intervention.

Outcome measures

Measure	Retinal Dystrophy n=10 Participants Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.	Healthy Age-Matched Controls n=10 Participants Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.
Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)	563.08 degrees^2 Interval 331.97 to 715.6	-3799.19 degrees^2 Interval -4482.99 to -2598.07

SECONDARY outcome

Timeframe: Baseline and two to four weeks

Gait speed will be measured using an inertial measurement unit attached to participants' shoes and will quantify the time taken to move from the beginning to end of a short mobility course.

Average of data from both feet with intervention.

Outcome measures

Measure	Retinal Dystrophy n=10 Participants Subjects with retinal dystrophy will have their visual field, gait and self-reported mobility tested at baseline. Subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.	Healthy Age-Matched Controls n=10 Participants Age-matched control subjects without eye disease will have their visual field, gait and self-reported mobility tested at baseline. Control subjects will then be fit with a head-mounted display and undergo a brief training with the investigators to learn about use of the device. After a 2 week period of in-home adaptation to the device, their visual field, gait and self-reported mobility will be retested. Head-Mounted Display: Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.
Change in Gait Speed Compared to Baseline (Measured in Seconds)	-.01 meters per second Interval -0.05 to 0.0	-.01 meters per second Interval -0.05 to 0.05

Adverse Events

Retinal Dystrophy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Age-Matched Controls

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

Sara

University of Michigan

Phone: 734-936-7567

Email: weisssar@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place