Status:
COMPLETED
SmartHMD for Improved Mobility
Lead Sponsor:
James Weiland
Conditions:
Low Vision
Orientation
Eligibility:
All Genders
14-89 years
Phase:
NA
Brief Summary
The National Eye Institute estimated about 3 million people over age 40 in the US had low vision in 2010 and projects an increase to nearly 5 million in 2030 and 9 million in 2050. Current assistive t...
Detailed Description
This study was originally intended as a single-arm study. Early results and unanticipated events related to component availability made it clear that multiple configurations of the device would be nec...
Eligibility Criteria
Inclusion
- Diagnosed with low vision
- Self reported difficulty with mobility and finding doors (either indoors or outdoors) and using signalized crosswalks.
- Ability to cooperate for tests
- Able to participate in all visits
Exclusion
- Unable to use head mounted display technology
- Unstable age-related macular degeneration within the past 3 months
- Unstable diabetic retinopathy within the past 3 months
- Unstable diabetes within the past 3 months
- Ocular infection or ocular inflammation in the past 3 months
- Ocular trauma within the past 6 months
- Intraocular surgery within 6 months
- Optical coherence tomography retinal findings of concern to investigator for unstable vision during the study
- Women who are pregnant (due to risk of falls and change in gait).
- Uncontrolled seizure disorder in the past 6 months
- Cerebrovascular accident occurring in the past 6 months
- Parkinson disease or neurological condition that limits mobility
- Alzheimer disease or other forms of dementia
- Conditions of concern to investigator that would confound orientation and mobility, such as severe arthritis, pain that limits ambulatory activities, or orthopedic surgery (e.g., hand, arm, shoulder, knee, or hip surgery within 12 months)
Key Trial Info
Start Date :
April 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03781583
Start Date
April 26 2019
End Date
November 7 2022
Last Update
December 12 2024
Active Locations (1)
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1
North Campus Research Complex
Ann Arbor, Michigan, United States, 48105