NCT06136169

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

May 14, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

November 9, 2023

Last Update Submit

August 6, 2025

Conditions

Homonymous HemianopiaHomonymous Quadrantanopia

Outcome Measures

Primary Outcomes (2)

  • Rate of early large head scans to the side of the field loss

    Proportion 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

    Proportion of hazards detected out of the total number of hazards on the side of the field loss

    Pre-training, Post-training (1 week)

Secondary Outcomes (5)

  • Rate of early large head scans to the side of the field loss

    Pre-training, post-training (up to 12 months)

  • Frequency of head scans to the side of the field loss

    Pre-training, Post-training (up to 12 months)

  • Magnitude of head scans to the side of the field loss

    Pre-training, Post-training (up to 12 months)

  • Detection rate for hazards on the side of the field loss

    Pre-training, post-training (up to 12 months)

  • Response times to hazards on the side of the field loss

    Pre-training, Post-training (up to 12 months)

Study Arms (1)

StudyArm

EXPERIMENTAL

Participants will receive reminder-cue scanning training in a driving simulator.

Behavioral: Reminder-cue scanning training

Interventions

Reminder-cue scanning trainingBEHAVIORAL

Auditory reminders to scan when scanning to the side of the field loss is inadequate

StudyArm

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Physical or general health problems that could impair the ability to operate the controls of the driving simulator or participate in the training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schepens Eye Research Institute of Mass Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alex Bowers, PhD

    Schepens Eye Research Institute of Mass Eye and Ear

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Bowers, PhD

CONTACT

617 912 2512alex_bowers@meei.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 18, 2023

Study Start

May 14, 2024

Primary Completion

May 11, 2025

Study Completion

May 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)