N/A
N=49
Collision Warning Device for Blind and Visually Impaired
Hemianopia · Hemianopsia · Peripheral Visual Field Defect · Blindness · Retinitis Pigmentosa
Bottom Line
View on ClinicalTrials.gov: NCT03057496 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Collision Incidents (All Contacts) — 13.79; 9.26 Rate (contacts per 100 hazards per hour) — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Collision warning device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Collision Incidents (All Contacts) |
13.79; 9.26 | < 0.001 sig |
| SECONDARY Number of Body Contacts |
1.13; 1.09 | — |
| SECONDARY Device Questionnaire |
3.68; 4.08; 3.05; 3.96 | — |
Summary
This study evaluates a novel collision warning device to help people with severe vision impairment or blindness avoid collisions with obstacles. The main hypothesis to be tested is that the device reduces the number of collisions with obstacles in everyday activities.
Eligibility Criteria
Inclusion Criteria
- Blindness (or very limited vision with visual acuity no better than "counting fingers"),
- Or severe peripheral field loss / tunnel vision (≤ 40° remaining visual field) with visual acuity of at least 20/200,
- Or homonymous hemianopia with visual acuity of at least 20/200;
- Able to walk independently either with or without mobility aids such as a long cane or guide dog (but without the aid of a sighted guide);
- Reports at least minor bumps or collisions within the last 3 months;
Exclusion Criteria
- Currently participating in a mobility training program
- Diagnosed dementia
- Significant cognitive decline
- Participants with hemianopia will be excluded if they have hemianopia for less than 3 months and/or have spatial neglect
Data sourced from ClinicalTrials.gov (NCT03057496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.