Back to resultsOptical Head-Mounted Display Technology for Low Vision Rehabilitation
Primary Purpose
Retinal Dystrophies, Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Head-Mounted Display
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Dystrophies
Eligibility 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
Sites / Locations
- Kellogg Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Retinal Dystrophy
Healthy Age-Matched Controls
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02983305
First Posted
November 4, 2016
Last Updated
September 20, 2019
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT02983305
Brief Title
Optical Head-Mounted Display Technology for Low Vision Rehabilitation
Official Title
Optical Head-Mounted Display Technology for Low Vision Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Dystrophies, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retinal Dystrophy
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Age-Matched Controls
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Head-Mounted Display
Other Intervention Name(s)
Epson Moverio
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)
Description
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.
Time Frame
Baseline and two to four weeks
Secondary Outcome Measure Information:
Title
Change in Gait Speed Compared to Baseline (Measured in Seconds)
Description
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.
Time Frame
Baseline and two to four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua R Ehrlich, MD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Optical Head-Mounted Display Technology for Low Vision Rehabilitation
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