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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY025677 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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This study will evaluate a new approach to training people with visual field loss to scan when driving
Homonymous visual field loss is the loss of vision on the same side in both eyes. The most common types are hemianopia (the loss of one half of the field of vision) and quadrantanopia (the loss of one quarter of the field of vision). Hemianopia and quadrantanopia may cause difficulties in seeing objects on the side of the field loss. People with these types of field loss can compensate by scanning (looking) toward the side of the field loss. However, sometimes they might not scan sufficiently well resulting in delayed responses to hazards when driving. The purpose of this research study is to evaluate a new approach, "reminder-cue scanning training", to training people with homonymous visual field loss to scan when driving.
Participants will receive reminder-cue scanning training in the driving simulator.Typically there will be three training sessions within about a 2-week period. In addition, participants will complete an evaluation in the driving simulator before and after the training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StudyArm | Experimental | Participants will receive reminder-cue scanning training in a driving simulator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reminder-cue scanning training | Behavioral | Auditory reminders to scan when scanning to the side of the field loss is inadequate |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Early Large Head Scans to the Side of the Field Loss | Percentage of intersections at which an early large head scan was made to the side of the field loss | Pre-training, post-training (1 week) |
| Detection Rate for Hazards on the Side of the Field Loss | Percentage of hazards detected out of the total number of hazards on the side of the field loss | Pre-training, Post-training (1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Head Scans to the Side of the Field Loss | Number of head scans per intersection to the side of the field loss. A validated algorithm was used to detect head scans, defined as lateral rotations of the head away from the straight ahead position toward either the left or the right, which exceeded a predefined threshold based on the participant's distance to the intersection: ≥ 4° (100 to 50 m to intersection), ≥ 6° (50 to 20m), ≥ 10° (20 to 0m). Savage SW, Zhang L, Swan G, Bowers AR (2020) The effects of age on the contributions of head and eye movements to scanning behavior at intersections. Transp Res Part F Traffic Psychol Behav. 73:128-142. Swan G, Goldstein RB, Savage SW, Zhang L, Ahmadi A, Bowers AR (2021) Automatic processing of gaze movements to quantify gaze scanning behaviors in a driving simulator. Behav Res Methods. 53(2): 487-506 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Bowers, PhD | Schepens Eye Research Institute of Mass Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schepens Eye Research Institute of Mass Eye and Ear | Boston | Massachusetts | 02114 | United States |
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Participants were recruited from local ophthalmology outpatient clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | All participants were allocated to receive three sessions of reminder-cue scanning training in the driving simulator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention |
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| Follow up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | All participants were allocated to receive three sessions of reminder-cue scanning training in the driving simulator |
| 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 | Rate of Early Large Head Scans to the Side of the Field Loss | Percentage of intersections at which an early large head scan was made to the side of the field loss | Posted | Number | 95% Confidence Interval | Percentage of intersections | Pre-training, post-training (1 week) | Intersections | Intersections |
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From start of training until end of follow-up, up to 4 weeks
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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 | Intervention | All participants were allocated to receive three sessions of reminder-cue scanning training in the driving simulator |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alex Bowers | Schepens Eye Research Institute of Mass 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 |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 3, 2025 | Mar 30, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Pre-training, Post-training (1 week) |
| Magnitude of Head Scans to the Side of the Field Loss | Mean magnitude (in degrees) of head scans to the side of the field loss. A validated algorithm was used to detect head scans, defined as lateral rotations of the head away from the straight ahead position toward either the left or the right, which exceeded a predefined threshold based on the participant's distance to the intersection: ≥ 4° (100 to 50 m to intersection), ≥ 6° (50 to 20m), ≥ 10° (20 to 0m). The magnitude is the lateral angular extent of the scan measured from the straight-ahead position to the furthest lateral position to the left or right. Savage SW, Zhang L, Swan G, Bowers AR (2020) The effects of age on the contributions of head and eye movements to scanning behavior at intersections. Transp Res Part F Traffic Psychol Behav. 73:128-142. Swan G, Goldstein RB, Savage SW, Zhang L, Ahmadi A, Bowers AR (2021) Automatic processing of gaze movements to quantify gaze scanning behaviors in a driving simulator. Behav Res Methods. 53(2): 487-506 | Pre-training, Post-training (1 week) |
| Response Times to Hazards on the Side of the Field Loss | Mean time (in seconds) between the hazard appearing and the horn-press response | Pre-training, Post-training (1 week) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Intersections |
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| Primary | Detection Rate for Hazards on the Side of the Field Loss | Percentage of hazards detected out of the total number of hazards on the side of the field loss | Posted | Number | 95% Confidence Interval | Percentage of hazards | Pre-training, Post-training (1 week) | Hazards | Hazards |
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| Secondary | Number of Head Scans to the Side of the Field Loss | Number of head scans per intersection to the side of the field loss. A validated algorithm was used to detect head scans, defined as lateral rotations of the head away from the straight ahead position toward either the left or the right, which exceeded a predefined threshold based on the participant's distance to the intersection: ≥ 4° (100 to 50 m to intersection), ≥ 6° (50 to 20m), ≥ 10° (20 to 0m). Savage SW, Zhang L, Swan G, Bowers AR (2020) The effects of age on the contributions of head and eye movements to scanning behavior at intersections. Transp Res Part F Traffic Psychol Behav. 73:128-142. Swan G, Goldstein RB, Savage SW, Zhang L, Ahmadi A, Bowers AR (2021) Automatic processing of gaze movements to quantify gaze scanning behaviors in a driving simulator. Behav Res Methods. 53(2): 487-506 | Posted | Mean | 95% Confidence Interval | Number of head scans per intersection | Pre-training, Post-training (1 week) | Intersections | Intersections |
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| Secondary | Magnitude of Head Scans to the Side of the Field Loss | Mean magnitude (in degrees) of head scans to the side of the field loss. A validated algorithm was used to detect head scans, defined as lateral rotations of the head away from the straight ahead position toward either the left or the right, which exceeded a predefined threshold based on the participant's distance to the intersection: ≥ 4° (100 to 50 m to intersection), ≥ 6° (50 to 20m), ≥ 10° (20 to 0m). The magnitude is the lateral angular extent of the scan measured from the straight-ahead position to the furthest lateral position to the left or right. Savage SW, Zhang L, Swan G, Bowers AR (2020) The effects of age on the contributions of head and eye movements to scanning behavior at intersections. Transp Res Part F Traffic Psychol Behav. 73:128-142. Swan G, Goldstein RB, Savage SW, Zhang L, Ahmadi A, Bowers AR (2021) Automatic processing of gaze movements to quantify gaze scanning behaviors in a driving simulator. Behav Res Methods. 53(2): 487-506 | Posted | Mean | 95% Confidence Interval | Degrees | Pre-training, Post-training (1 week) | Intersections | Intersections |
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| Secondary | Response Times to Hazards on the Side of the Field Loss | Mean time (in seconds) between the hazard appearing and the horn-press response | Posted | Mean | 95% Confidence Interval | Seconds | Pre-training, Post-training (1 week) | Hazards | Hazards |
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| 0 |
| 16 |
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| 16 |
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| 16 |
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| D001766 |
| Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |