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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collision warning device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the one-month period of device use |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Body Contacts | Collision incidents with body contacts recorded by the device | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Bowers, PhD | Schepens Eye Research Institute, Mass Eye and Ear | Principal Investigator |
| Gang Luo, PhD | Schepens Eye Research Institute, Mass Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schepens Eye Research Institute | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32832221 | Background | 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. | |
| 34292298 | Derived | 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. |
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Subjects were recruited between January 2018 and May 2019 via referrals from the Carroll Center for the Blind, the Massachusetts Commission for the Blind and practitioners at vision rehabilitation clinics in the Greater Boston area, and via a pool of volunteers who had previously participated in studies in our lab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silent and Active Mode | During the period of home-use of the device, all participants experienced both the silent and active modes on a random schedule. Thus participant flow was the same for silent and active modes and is described for all participants together. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analysis population includes only those subjects who completed the one-month period of device use and had data successfully recorded by the device.
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| ID | Title | Description |
|---|---|---|
| BG000 | Silent and Active Mode | During the period of home-use of the device, all participants experienced both the silent and active modes on a random schedule. Thus the baseline measures are the same for active and silent modes (as it was the same participants for both modes) and are reported together. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Median | Inter-Quartile Range | Rate (contacts per 100 hazards per hour) | During the one-month period of device use |
|
Adverse event data were collected during the one-month period when subjects were using the device.
A brief questionnaire was administered to each subject by telephone each week during the one-month period of device use to check on how much they were using the device and whether they had encountered any difficulties. One question specifically asked whether the subject had experienced any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silent and Active Mode | During the period of home-use of the device, all participants experienced both the silent and active modes on a random schedule. Neither the subject nor the researcher recording adverse events knew whether the device was in silent or active mode at the time when an event occurred, thus the adverse events are reported for all participants and both modes together. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor contact with object in the environment | General disorders | Systematic Assessment | A minor contact, brushing against or bumping into an object (e.g., bushes, overhanging branches) in the environment when walking |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alex Bowers | Schepens Eye Research Institute of Massachusetts Eye and Ear | 617 912 2512 | alex_bowers@meei.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 26, 2019 | Oct 29, 2020 | ICF_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2021 | Jan 25, 2021 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| D001766 | Blindness |
| D012174 | Retinitis Pigmentosa |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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.
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Although this is a single-arm study, participants will be masked in the sense that they will not know whether the device is operating in the active mode (intervention condition), when it gives warnings, or the 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. The investigator conducting the statistical analyses will also be masked as to whether the device was in the active or silent mode
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|
| During the one-month period of device use |
| Device failure |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Habitual mobility aid | Count of Participants | Participants |
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| Cause of vision impairment | Count of Participants | Participants |
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| Vision impairment onset | Count of Participants | Participants |
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| Duration of vision loss | Median | Full Range | years |
|
| Amount of vision | Count of Participants | Participants |
|
| OG001 | Active Mode | Participants used the collision warning device as much as possible for about one month during everyday activities, when walking indoors and outdoors. The device switched between silent and active mode on a random schedule. In the active mode the device detected potential collisions and gave active warnings to the users via vibro-tactile wristbands. |
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| Secondary | Number of Body Contacts | Collision incidents with body contacts recorded by the device | 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 | Posted | Median | Inter-Quartile Range | Rate (contacts per 100 hazards per hour) | During the one-month period of device use |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale | During the one-month period of device use |
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| 0 |
| 36 |
| 0 |
| 36 |
| 6 |
| 36 |
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| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015785 | Eye Diseases, Hereditary |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009798 | Ocular Hypertension |
| Title | Measurements |
|---|---|
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| Ease of operation |
|