Clinical trial NCT02983305: Optical Head-Mounted Display Technology for Low Vision Rehabilitation
Official title: Optical Head-Mounted Display Technology for Low Vision Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Dystrophies
Healthy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)
timeFrame: Baseline and two to four weeks
Secondary outcomes:
measure: Change in Gait Speed Compared to Baseline (Measured in Seconds)
timeFrame: Baseline and two to four weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Joshua R Ehrlich, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: