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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retinal Dystrophy | Experimental | 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. |
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| Healthy Age-Matched Controls | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head-Mounted Display | Device | 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 | Description | Time Frame |
|---|---|---|
| Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared) | 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. | Baseline and two to four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Speed Compared to Baseline (Measured in Seconds) | 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. | Baseline and two to four weeks |
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Inclusion criteria for subjects with retinal dystrophy:
Inclusion criteria for control subjects:
Exclusion criteria for subjects with retinal dystrophy:
Exclusion criteria for control subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua R Ehrlich, MD, MPH | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared) | 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. | Posted | Median | Inter-Quartile Range | degrees^2 | Baseline and two to four weeks |
|
Through study completion, an average of 2-4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara | University of Michigan | 734-936-7567 | weisssar@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2018 | Aug 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058499 | Retinal Dystrophies |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000080310 | Smart Glasses |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Visual Field Area | Average of both eyes visual fields at baseline (no intervention). | Median | Inter-Quartile Range | degrees^2 |
|
| Gait Speed | Average of both feet at baseline (no intervention). | Median | Inter-Quartile Range | meters per second |
|
| OG001 | 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. |
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|
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| Secondary | Change in Gait Speed Compared to Baseline (Measured in Seconds) | 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. | Posted | Median | Inter-Quartile Range | meters per second | Baseline and two to four weeks |
|
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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Test of equivalence of gait speed under intervention conditions. |
| Wilcoxon (Mann-Whitney) |
| 0.27 |
P < .05 was considered a priori to be statistically significant. |
| Equivalence |
Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions. |
| Comparison between study arms of the change in the gait speed detected between baseline and intervention. | Wilcoxon (Mann-Whitney) | 0.79 | P < .05 was considered a priori to be statistically significant. | Equivalence | Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions. |