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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06136169
Other study ID # HST_Pilot
Secondary ID R01EY025677
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date June 2025

Study information

Verified date March 2024
Source Massachusetts Eye and Ear Infirmary
Contact Alex Bowers, PhD
Phone 617 912 2512
Email alex_bowers@meei.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate a new approach to training people with visual field loss to scan when driving


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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: - Hemi-spatial neglect - Significant cognitive impairment - Physical or general health problems that could impair the ability to operate the controls of the driving simulator or participate in the training

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Reminder-cue scanning training
Auditory reminders to scan when scanning to the side of the field loss is inadequate

Locations

Country Name City State
United States Schepens Eye Research Institute Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts Eye and Ear Infirmary National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in rate of adequate scanning to the side of the field loss Proportion of intersections at which scanning was adequate to the side of the field loss Pre-training, post-training (up to 6 weeks)
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