Optical Head-Mounted Display Technology for Low Vision Rehabilitation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-26

Study Completion Date

2018-11-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Retinal Dystrophies Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Head-Mounted Display

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Head-Mounted Display

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Epson Moverio

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* movement disorder that precludes evaluation of mobility
* functional vision loss
* pregnant women

* visually significant ocular condition other than correctable refractive error
* movement disorder that precludes evaluation of mobility
* functional vision loss
* pregnant women

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes