Optical Head-Mounted Display Technology for Low Vision Rehabilitation

University of Michigan

Status: Completed

Conditions: Healthy; Retinal Dystrophies

Treatments: Device: Head-Mounted Display

Study type: Interventional

Funder types: Other

Identifiers

NCT02983305

HUM00110408

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

Retinal Dystrophy

Experimental 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.

Treatment:

Device: Head-Mounted Display

Healthy Age-Matched Controls

Experimental group

Description:

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.

Treatment:

Device: Head-Mounted Display