Optical Head-Mounted Display Technology for Low Vision Rehabilitation

Not Applicable

Completed

• Conditions: Retinal Dystrophies; Healthy
• Interventions: Device: Head-Mounted Display

• Registration Number: NCT02983305
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-06
• Study Start: 2017-06-26
• Primary Completion: 2018-11-21
• Study Completion: 2018-11-21
• Results First Submitted: 2019-08-23
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-20
• Last Update Submitted: 2019-09-20
• Results First Posted: 2019-10-09
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retinal Dystrophy	Head-Mounted Display	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.
Healthy Age-Matched Controls	Head-Mounted Display	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.

Primary Outcome Measures

Name	Time	Method
Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)	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 Outcome Measures

Name	Time	Method
Change in Gait Speed Compared to Baseline (Measured in Seconds)	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.

Trial Locations

Locations (1)

Kellogg Eye Center; 🇺🇸 Ann Arbor, Michigan, United States