Optical Head-Mounted Display Technology for Low Vision Rehabilitation

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02983305
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The goal of this study is to examine the ability of optical head-mounted display technology to enlarge the visual field of patients with severe visual field loss due to retinal dystrophy and to improve mobility and patient-reported outcomes.

Condition or Disease	Intervention/Treatment	Phase
Retinal Dystrophies; Healthy	Device: Head-Mounted Display	N/A

Detailed Description

Worldwide it is estimated that 191 million people have moderate to severe visual impairment (MSVI) and an additional 32.4 million are blind. Patients with uncorrectable MSVI may undergo low vision rehabilitation (LVR), which has been shown to improve functional abilities, such as mobility. However, existing LVR strategies do not adequately address severe visual field constriction.

In this pilot study, the investigators will test the hypothesis that optical head-mounted display (HMD) technology expands constricted visual fields and improves mobility outcomes for patients with retinal dystrophy. We will use the Moverio HMD platform which is considered a non-significant risk device. Outcomes for patients with retinal dystrophy will be compared to normal age-matched controls.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Optical Head-Mounted Display Technology for Low Vision Rehabilitation
• Actual Study Start Date: Jun 26, 2017
• Actual Primary Completion Date: Nov 21, 2018
• Actual Study Completion Date: Nov 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.; Other Names: Epson Moverio
Experimental: 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.	Device: 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.; Other Names: Epson Moverio

Outcome Measures

Primary Outcome Measures

1. Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared) [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.

Secondary Outcome Measures

1. Change in Gait Speed Compared to Baseline (Measured in Seconds) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria for subjects with retinal dystrophy:

• diagnosis of retinal dystrophy

• severe vision loss that constitutes legal blindness

• able to perform a reliable Goldmann visual field test

• constricted visual field less than or equal to 20 degrees by Goldmann perimetry using the III4e stimulus in at least one eye with best-corrected visual acuity ≥ 20/60

Inclusion criteria for control subjects:

• healthy controls

• visit history with the Comprehensive and Pediatric Ophthalmology Services at the University of Michigan

• able to perform a reliable Goldmann visual field test

Exclusion criteria for subjects with retinal dystrophy:

• movement disorder that precludes evaluation of mobility

• functional vision loss

• pregnant women

Exclusion criteria for control subjects:

• visually significant ocular condition other than correctable refractive error

• movement disorder that precludes evaluation of mobility

• functional vision loss

• pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kellogg Eye Center	Ann Arbor	Michigan	United States	48105

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Joshua R Ehrlich, MD, MPH, University of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 15, 2018

More Information

Publications

None provided.

• Responsible Party: Joshua Ehrlich, Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT02983305
• Other Study ID Numbers: HUM00110408
• First Posted: Dec 6, 2016
• Last Update Posted: Oct 9, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Vision, Low; Retinal Dystrophies

Study Results

Participant Flow

Arm/Group Title	Retinal Dystrophy	Healthy Age-Matched Controls
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	12	10
COMPLETED	10	10
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Retinal Dystrophy	Healthy Age-Matched Controls	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	10	10	20
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	33.5	33	33.5
Sex: Female, Male (Count of Participants)
Female	5 50%	5 50%	10 50%
Male	5 50%	5 50%	10 50%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Visual Field Area (degrees^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [degrees^2]	568.96	19280.09	19009.42
Gait Speed (meters per second) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [meters per second]	1.27	1.25	1.26

Outcome Measures

1. Primary Outcome

Title	Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)
Description	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.
Time Frame	Baseline and two to four weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Retinal Dystrophy	Healthy Age-Matched Controls
Arm/Group Description	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.	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.
Measure Participants	10	10
Median (Inter-Quartile Range) [degrees^2]	563.08	-3799.19

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Retinal Dystrophy, Healthy Age-Matched Controls
	Comments	Test of equivalence of visual field area at baseline.
	Type of Statistical Test	Equivalence
	Comments	Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.
Statistical Test of Hypothesis	p-Value	.0001
	Comments	P < .05 was considered a priori to be statistically significant.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Retinal Dystrophy, Healthy Age-Matched Controls
	Comments	Test of equivalence of visual field area under intervention conditions.
	Type of Statistical Test	Equivalence
	Comments	Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	P < .05 was considered a priori to be statistically significant.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Retinal Dystrophy, Healthy Age-Matched Controls
	Comments	Comparison between study arms of the change in the visual field area (average of both eyes) detected between baseline and intervention.
	Type of Statistical Test	Equivalence
	Comments	Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.
Statistical Test of Hypothesis	p-Value	.003
	Comments	P < .05 was considered a priori to be statistically significant.
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Change in Gait Speed Compared to Baseline (Measured in Seconds)
Description	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.
Time Frame	Baseline and two to four weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Retinal Dystrophy	Healthy Age-Matched Controls
Arm/Group Description	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.	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.
Measure Participants	10	10
Median (Inter-Quartile Range) [meters per second]	-.01	-.01

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Retinal Dystrophy, Healthy Age-Matched Controls
	Comments	Test of equivalence of gait speed at baseline.
	Type of Statistical Test	Equivalence
	Comments	Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.
Statistical Test of Hypothesis	p-Value	0.38
	Comments	P < .05 was considered a priori to be statistically significant.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Retinal Dystrophy, Healthy Age-Matched Controls
	Comments	Test of equivalence of gait speed under intervention conditions.
	Type of Statistical Test	Equivalence
	Comments	Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.
Statistical Test of Hypothesis	p-Value	0.27
	Comments	P < .05 was considered a priori to be statistically significant.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Retinal Dystrophy, Healthy Age-Matched Controls
	Comments	Comparison between study arms of the change in the gait speed detected between baseline and intervention.
	Type of Statistical Test	Equivalence
	Comments	Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.
Statistical Test of Hypothesis	p-Value	0.79
	Comments	P < .05 was considered a priori to be statistically significant.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Through study completion, an average of 2-4 weeks.
Arm/Group Title	Retinal Dystrophy		Healthy Age-Matched Controls
Arm/Group Description	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.		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.
All Cause Mortality
	Retinal Dystrophy		Healthy Age-Matched Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)
Serious Adverse Events
	Retinal Dystrophy		Healthy Age-Matched Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Retinal Dystrophy		Healthy Age-Matched Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.