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Optical Head-Mounted Display Technology for Low Vision Rehabilitation

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ClinicalTrials.gov Identifier: NCT02983305
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Joshua Ehrlich, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Retinal Dystrophies Healthy Device: Head-Mounted Display Not Applicable

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  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical Head-Mounted Display Technology for Low Vision Rehabilitation
Actual Study Start Date : June 26, 2017
Actual Primary Completion Date : November 21, 2018
Actual Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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 Name: 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 Name: Epson Moverio




Primary Outcome Measures :
  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: Two 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.


Secondary Outcome Measures :
  1. Change in gait speed compared to baseline (measured in seconds) [ Time Frame: Two 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.


Other Outcome Measures:
  1. Change in patient-reported ability for independent mobility as assessed by subject responses a validated questionnaire. [ Time Frame: Two weeks ]
    Independent Mobility Questionnaire (scored from 35 to 175 with 175 representing extreme mobility impairment)

  2. Change in patient-reported mobility and independence as assessed by subject responses a validated questionnaire. [ Time Frame: Two weeks ]
    Mobility and Independence domain of the Impact of Vision Impairment Questionnaire (scored from 0 to 33 with 0 representing poor mobility and independence)

  3. Change in stride length compared to baseline (measured in mm) [ Time Frame: Two weeks ]
    Inertial measurement units attached to participants' shoes will track the length of each step as they walk through a short mobility course.

  4. Change in stride width compared to baseline (measured in mm) [ Time Frame: Two weeks ]
    Inertial measurement units attached to participants' shoes will track the width of each step as they walk through a short mobility course.

  5. Change in foot orientation compared to baseline (measured in degrees) [ Time Frame: Two weeks ]
    Inertial measurement units attached to participants' shoes will track the orientation of their feet as they walk through a short mobility course.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983305


Locations
United States, Michigan
Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Joshua R Ehrlich, MD, MPH University of Michigan

Responsible Party: Joshua Ehrlich, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02983305     History of Changes
Other Study ID Numbers: HUM00110408
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Vision, Low
Retinal Dystrophies
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Retinal Degeneration
Retinal Diseases