Optical Head-Mounted Display Technology for Low Vision Rehabilitation

Healthy Clinical Trial

Official title:

Optical Head-Mounted Display Technology for Low Vision Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983305
• Other study ID #: HUM00110408
• Status: Completed
• Phase: N/A
• Start date: June 26, 2017
• Est. completion date: November 21, 2018

Study information

• Verified date: September 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Retinal Dystrophies
• Vision, Low

Intervention

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.

Locations

Country	Name	City	State
United States	Kellogg Eye Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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