- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06047717
Vision Loss Impact on Navigation in Virtual Reality
December 6, 2023 updated by: Krystel Huxlin, University of Rochester
The Impact of Vision Loss on Naturalistic Behavior and Navigation in Virtual Reality
The purpose of this research is to better understand the impact of cortically-induced blindness (CB) and the compensatory strategies subjects with this condition may develop on naturalistic behaviors, specifically, driving.
Using a novel Virtual Reality (VR) program, the researchers will gather data on steering behavior in a variety of simulated naturalistic environments.
Through the combined use of computer vision, deep learning, and gaze-contingent manipulations of the visual field, this work will test the central hypothesis that changes to visually guided steering behaviors in CB are a consequence of changes to the visual sampling and processing of task-related motion information (i.e., optic flow).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chrys Callan
- Phone Number: 585-276-3426
- Email: Christine_Callan@URMC.Rochester.Edu
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- Recruiting
- University of Rochester
-
Principal Investigator:
- Krystel Huxlin, PhD
-
Contact:
- Christine Callan
- Phone Number: 585-276-3426
- Email: christine_callan@urmc.rochester.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Cortically Blind Group:
Inclusion Criteria:
- Residents of the United States or Canada
- Presence of one-sided stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range of 21 - 75 years (verified by MRI and/or CT scans)
- Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey or equivalent perimetry.
- Willing, able, and competent to provide their own informed consent
- Cognitively able, responsible to understand written and oral instructions in English
- Emmetropic or else wear corrective contact lenses inside the virtual reality headset
Exclusion Criteria:
- Those who have never driven or earned a drivers' license
- Past or present ocular disease interfering with visual acuity
- Best corrected visual acuity (BCVA) worse than 20/40 in either eye
- Sustained damage to the dorsal lateral geniculate nucleus
- Presence of diffuse, whole-brain degenerative processes
- Presence of brain damage deemed by study staff to potentially interfere with outcome measures
- History of traumatic brain injury
- Documented history of drug/alcohol abuse
- Diagnosis of cognitive or seizure disorders
- Diagnosis of one-sided attentional neglect
Control Group:
Inclusion Criteria:
- Normal or corrected-to-normal vision, who are between the ages of 21 and 75 years of age, roughly matched to the age of CB subjects enrolled above
- Competent and responsible, as determined by the Principal Investigator
- Willing, able, and competent to provide their own informed consent
- Normal cognitive abilities, be able to understand written and oral instructions in English
- Emmetropic or else wear corrective contact lenses inside the virtual reality headset
Exclusion Criteria:
- Subjects who have never driven or earned a drivers' license
- BCVA worse than 20/40 in either eye
- Presence of vision loss from ocular diseases or disorders
- Presence of a visual field defect
- Inability to wear corrective contact lenses inside the virtual reality helmet if required to see clearly
- Subjects with a history of neurological disorders
- Subjects with a history of TBI
- Persons who lack the competence or are otherwise unable to perform the visual testing as directed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual Reality (VR) Driving Task: Cortically Blind Cohort
Persons who have sustained cortical blindness will perform a driving task in VR, in which they must steer through a series of parameterized turns while maintaining their virtual vehicle centered between the two red lines delineating the "road" edge.
|
Participants will steer a virtual car with the goal of staying in the center of a single-lane roadway while traveling at a constant speed of 26.6 m/s (approximately 60 miles/hr).
The roadway alternates between a series of straights and turns of different radii to both the left and the right.
This allows for careful control of task difficulty, and for the repeated presentation of specific conditions across multiple "trials" (i.e.
turns in the road) in a randomized order.
In addition, the density of the visual texture elements in the virtual environment that provide optic flow (OF) signal is also varied.
The low-density OF condition has no road texture or foliage, and only the solid road edges on a flat-black ground plane.
The medium-density OF condition has sparse textural elements distributed on the ground plane, and the high-density OF condition has high density road texture and a canopy of road-side trees that provide texture extending far above the horizon.
|
Experimental: Virtual Reality (VR) Driving Task: Healthy Control Cohort
Healthy controls with no vision loss will perform a driving task in VR, in which they must steer through a series of parameterized turns while maintaining their virtual vehicle centered between the two red lines delineating the "road" edge.
|
Participants will steer a virtual car with the goal of staying in the center of a single-lane roadway while traveling at a constant speed of 26.6 m/s (approximately 60 miles/hr).
The roadway alternates between a series of straights and turns of different radii to both the left and the right.
This allows for careful control of task difficulty, and for the repeated presentation of specific conditions across multiple "trials" (i.e.
turns in the road) in a randomized order.
In addition, the density of the visual texture elements in the virtual environment that provide optic flow (OF) signal is also varied.
The low-density OF condition has no road texture or foliage, and only the solid road edges on a flat-black ground plane.
The medium-density OF condition has sparse textural elements distributed on the ground plane, and the high-density OF condition has high density road texture and a canopy of road-side trees that provide texture extending far above the horizon.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Virtual Reality (VR) Lane Deviation / Offset
Time Frame: Day 0
|
Virtual lane offset is a measure of driving accuracy, which involves computing the divergence (in virtual meters) from the center of the single-lane virtual roadway, relative to the position of the driver's head and averaged over the duration of each turn.
The researchers will compare the variance of lane offset in virtual meters between Cortically Blind (CB) and control subjects.
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
September 8, 2023
First Submitted That Met QC Criteria
September 18, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00008669
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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