- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06136169
Reminder-cue Scanning Training for Homonymous Visual Field Loss
Reminder-cue Scanning Training for People With Homonymous Visual Field Loss
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Schepens Eye Research Institute of Mass Eye and Ear
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Homonymous hemianopia or homonymous quadrantanopia for at least 3 months
- Binocular visual acuity of at least 20/40
- Prior or current driving experience
- Able to attend multiple study visits
- Able to communicate in English sufficiently to understand the study procedures
Exclusion Criteria:
- Physical or general health problems that could impair the ability to operate the controls of the driving simulator or participate in the training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: StudyArm
Participants will receive reminder-cue scanning training in a driving simulator.
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Auditory reminders to scan when scanning to the side of the field loss is inadequate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Early Large Head Scans to the Side of the Field Loss
Time Frame: Pre-training, post-training (1 week)
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Percentage of intersections at which an early large head scan was made to the side of the field loss
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Pre-training, post-training (1 week)
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Detection Rate for Hazards on the Side of the Field Loss
Time Frame: Pre-training, Post-training (1 week)
|
Percentage of hazards detected out of the total number of hazards on the side of the field loss
|
Pre-training, Post-training (1 week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Head Scans to the Side of the Field Loss
Time Frame: Pre-training, Post-training (1 week)
|
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 |
Pre-training, Post-training (1 week)
|
|
Magnitude of Head Scans to the Side of the Field Loss
Time Frame: Pre-training, Post-training (1 week)
|
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
Time Frame: Pre-training, Post-training (1 week)
|
Mean time (in seconds) between the hazard appearing and the horn-press response
|
Pre-training, Post-training (1 week)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alex Bowers, PhD, Schepens Eye Research Institute of Mass Eye and Ear
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HST_Pilot
- R01EY025677 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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