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Completed

NCT Number: NCT02983305

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Epson Moverio

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)

    Time frame: Baseline and two to four weeks

    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.

Secondary outcomes

  1. Change in Gait Speed Compared to Baseline (Measured in Seconds)

    Time frame: Baseline and two to four weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2016
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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