HemianopiaNCT03057496

Collision Warning Device for Blind and Visually Impaired

A study testing Collision warning device in people with Hemianopia and Hemianopsia, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hemianopia, Hemianopsia, Peripheral Visual Field Defect
What is being tested?: Collision warning device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 22 Jan 2018to 5 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Schepens Eye Research Institute
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Wearable Collision Warning Device for Blind and Visually Impaired: Clinical Trial (As Part of: 'Development of a Vision Assistive Device for Veterans With Traumatic Brain Injury-Associated Visual Dysfunctions')

Read the detailed description

Participants with blindness or severe visual field loss (hemianopia or tunnel vision) will be trained to use a collision warning device that alerts them to impending collisions. Participants will use the device at home during everyday mobility for about 1 month. The device is designed to supplement existing mobility devices, such as a long cane or dog guide. The device will provide warnings about potential collisions with mid- or high-level obstacles (which are typically not detected by a long cane).

Conditions: Hemianopia, Hemianopsia, Peripheral Visual Field Defect, Blindness, Retinitis Pigmentosa, Glaucoma
Being tested: Collision warning device
Medical subject headings: Hemianopsia, Blindness, Retinitis Pigmentosa, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Collision warning deviceDevice
The collision warning device is a pocket-sized, electronic system that includes a micro-computer, a clip-on miniature camera, a gyro-sensor, an accelerometer, and a rechargeable battery, all contained within a shoulder bag. It is about the size of a smart phone. When a potential collision is detected by the device it emits a warning to the user, either in the form of an audible beep or a tactile warning through bracelets worn on the wrist. The time to collision will be coded in both the auditory and tactile domains. The device is designed to only give warnings about high risk collisions, so the users will not be continually bombarded by warnings for every potential collision object in the environment.

Study groups in NCT03057496
Study group	Role	What they receive
Intervention	Experimental	Participants will use the collision warning device as much as possible for about one month during everyday activities, when walking indoors and outdoors. Receives: Device: Collision warning device

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Collision Incidents (All Contacts)
Collision incidents recorded by the device in everyday use, including long cane contacts and body contacts with surrounding objects in the environment.
Measured: During the one-month period of device use

Secondary outcomes (2)

Number of Body Contacts
Collision incidents with body contacts recorded by the device
Measured: During the one-month period of device use
Device Questionnaire
Questionnaire addressing participants' experiences of using the device. Scores were on a 5-point rating scale (1 to 5) with higher scores representing a better score. Questions were grouped into four main categories: i) overall satisfaction, ii) comfort, iii) mobility benefit, and iv) ease of operation. An average score was computed for questions within each category.
Measured: During the one-month period of device use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 20185 Dec 2019

First posted20 Feb 2017
Study start22 Jan 2018
Primary completion8 Nov 2019
Study completion5 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HemianopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: The device will operate in two modes: active mode (intervention condition), when it gives warnings and, silent mode (control condition), when it does not give warnings. The device will be programmed to generate a different randomized active/silent schedule for each subject. Participants will not know whether it is in the active or silent mode.
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03057496
Sponsor's protocol ID: 1007377
Status last verified: Jan 2021
First submitted: 14 Feb 2017
Last updated: 10 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Pundlik S, Baliutaviciute V, Moharrer M, Bowers AR, Luo G. Data Acquisition, Processing, and Reduction for Home-Use Trial of a Wearable Video Camera-Based Mobility Aid. Transl Vis Sci Technol. 2020 Jun 11;9(7):14. doi: 10.1167/tvst.9.7.14. eCollection 2020 Jun.
PubMed 32832221
Pundlik S, Baliutaviciute V, Moharrer M, Bowers AR, Luo G. Home-Use Evaluation of a Wearable Collision Warning Device for Individuals With Severe Vision Impairments: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Sep 1;139(9):998-1005. doi: 10.1001/jamaophthalmol.2021.2624.
PubMed 34292298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Ameliorating Stroke-induced Hemianopia Via Multisensory Training
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Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
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Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia
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Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour
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All Hemianopia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Wearable Collision Warning Device for Blind and Visually Impaired: Clinical Trial (As Part of: 'Development of a Vision Assistive Device for Veterans With Traumatic Brain Injury-Associated Visual Dysfunctions')
ClinicalTrials.gov ID: NCT03057496
Acronym / sponsor ID: 1007377
Conditions: Hemianopia, Hemianopsia, Peripheral Visual Field Defect, Blindness, Retinitis Pigmentosa, Glaucoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
Study start: 22 Jan 2018 (actual)
Primary completion: 8 Nov 2019 (actual)
Study completion: 5 Dec 2019 (actual)
First posted: 20 Feb 2017 (actual)
Results: Posted 21 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The device will operate in two modes: active mode (intervention condition), when it gives warnings and, silent mode (control condition), when it does not give warnings. The device will be programmed to generate a different randomized active/silent schedule for each subject. Participants will not know whether it is in the active or silent mode.

Arm	Type	Receives
Intervention	Experimental	Device: Collision warning deviceParticipants will use the collision warning device as much as possible for about one month during everyday activities, when walking indoors and outdoors.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Collision warning deviceThe collision warning device is a pocket-sized, electronic system that includes a micro-computer, a clip-on miniature camera, a gyro-sensor, an accelerometer, and a rechargeable battery, all contained within a shoulder bag. It is about the size of a smart phone. When a potential collision is detected by the device it emits a warning to the user, either in the form of an audible beep or a tactile warning through bracelets worn on the wrist. The time to collision will be coded in both the auditory and tactile domains. The device is designed to only give warnings about high risk collisions, so the users will not be continually bombarded by warnings for every potential collision object in the environment.	Device	Intervention

Primary outcome

Number of Collision Incidents (All Contacts)
Time frame: During the one-month period of device use
Collision incidents recorded by the device in everyday use, including long cane contacts and body contacts with surrounding objects in the environment.

2 secondary outcomes

Number of Body Contacts
Time frame: During the one-month period of device use
Device Questionnaire
Time frame: During the one-month period of device use

Results and safety

Results posted to the registry on 21 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Silent and Active Mode	49	31

Primary outcome: Number of Collision Incidents (All Contacts)

Time frame: During the one-month period of device use. Median (Inter-Quartile Range). Unit: Rate (contacts per 100 hazards per hour)

Measure	Silent Mode n = 31	Active Mode n = 31
Value	13.79 (7.28 to 24.29)	9.26 (6.56 to 14.96)

Silent Mode vs Active Mode: Rate ratio: 0.627 (95% CI 0.536 to 0.734), p < 0.001, Mixed Models Analysis

Population analysed: The device switched between active and silent modes on a random schedule so data about collision incidents were available for each subject for both conditions

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the one-month period when subjects were using the device.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silent and Active Mode	0 of 36 (0%)	6 of 36 (16.7%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32832221Pundlik S, Baliutaviciute V, Moharrer M, Bowers AR, Luo G. Data Acquisition, Processing, and Reduction for Home-Use Trial of a Wearable Video Camera-Based Mobility Aid. Transl Vis Sci Technol. 2020 Jun 11;9(7):14. doi: 10.1167/tvst.9.7.14. eCollection 2020 Jun.
Derived from this study: PubMed 34292298Pundlik S, Baliutaviciute V, Moharrer M, Bowers AR, Luo G. Home-Use Evaluation of a Wearable Collision Warning Device for Individuals With Severe Vision Impairments: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Sep 1;139(9):998-1005. doi: 10.1001/jamaophthalmol.2021.2624.
Individual participant dataSharing planned: No

Related trials for Hemianopia

Not yet recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
Not yet recruiting
Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia
Hemianopia Homonymous, Stroke
Not yet recruiting
Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour
Hemianopsia, Virtual Reality

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alex Bowers, PhD principal investigator

Schepens Eye Research Institute, Mass Eye and Ear

Gang Luo, PhD principal investigator

Schepens Eye Research Institute, Mass Eye and Ear

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Collision warning device in people with Hemianopia and Hemianopsia, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Collision Incidents (All Contacts) (time frame: During the one-month period of device use). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03057496, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.