Optical Head-Mounted Display Technology for Low Vision Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Retinal Dystrophies
• Intervention / Treatment: Device: Head-Mounted Display

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: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Kellogg Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

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.	Device: 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.; Other Names: Epson Moverio
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.	Device: 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.; Other Names: Epson Moverio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Joshua R Ehrlich, MD, MPH, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Actual): November 21, 2018
• Study Completion (Actual): November 21, 2018

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Retinal Degeneration; Retinal Diseases; Sensation Disorders; Vision Disorders; Vision, Low; Retinal Dystrophies
• Other Study ID Numbers: HUM00110408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No