Optical Head-Mounted Display Technology for Low Vision Rehabilitation

NCT02983305 | Completed Results FDA Device

• 1 other identifier: HUM00110408
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Dystrophies; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Gait Speed Compared to Baseline (Measured in Seconds)

  Baseline and two to four weeks

Study Arms (2)

Retinal Dystrophy

EXPERIMENTAL

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

Healthy Age-Matched Controls

EXPERIMENTAL

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

Interventions

Head-Mounted Display 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.

Also known as: Epson Moverio

Healthy Age-Matched Controls; Retinal Dystrophy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Retinal Dystrophies

Interventions

Smart Glasses

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Results Point of Contact

• Title: Sara
• Organization: University of Michigan

weisssar@umich.edu

734-936-7567

Study Officials

• Joshua R Ehrlich, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: December 6, 2016
• Study Start: June 26, 2017
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: October 9, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)