Optical Head-Mounted Display Technology for Low Vision Rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Kellogg Eye Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
|
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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.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)
Time Frame: Baseline and two to four weeks
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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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Gait Speed Compared to Baseline (Measured in Seconds)
Time Frame: 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. |
Baseline and two to four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joshua R Ehrlich, MD, MPH, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00110408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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