Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking

Hemianopsia Clinical Trial

Official title:

Monocular Visual Confusion for Field Expansion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141604
• Other study ID #: 2021P003330
• Secondary ID: R01EY031777
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Sandhya Shekar
• Phone: 6179122522
• Email: sandhya_shekar[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are developing a new test of pedestrian hazard detection in virtual reality (VR) head-mounted display (HMD) headset, which shows virtual oncoming pedestrians in 3D while subjects are walking in real-world environment, for evaluation of visual field expansion to improve mobility in people with visual field loss.

Description:

The investigators will develop a new pedestrian hazard detection test and conduct a single arm interventional clinical trial to evaluate simulated low vision assistive devices in a sample of field loss subjects. Pedestrian detection performance with and without field expansion information will be tested and compared. The study will include 1 to 4 visits (each 2 to 4 hours) depending on the number of trials and experimental conditions (e.g., with and without simulated assistive devices) the subject is comfortable completing. The time between visits may vary depending on scheduling constraints and availability. During each visit, the subject will complete a series of simulated collision avoidance trials in VR requiring the detection and natural avoidance of a colliding pedestrian (alongside non-colliding pedestrians) while physically walking through an empty corridor. The study will be considered minimal-risk since there will be no physical obstacles that present actual collision risks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion criteria:

• At least 14 years of age (no upper age limit)
• In sufficiently good health to be able to complete sessions lasting 2-3 hours
• Able to understand English
• Able to give voluntary, informed consent
• Able to independently move short distances
• Binocular vision parameters within normal limits (Stereopsis = 100 arc sec on any stereo test)
• Visual field loss, either peripheral field loss (<30 degrees diameter) or hemianopic field loss (blind in half of visual field)
• Better than 20/100 visual acuity in the worse eye

Exclusion criteria:

• Patients with any self-reported physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study
• Any person with a self-reported medical history (such as pacemaker use or photosensitive epilepsy) or physical condition listed on the device manual of the Oculus / HMD system used for the experiment as a contraindication
• Any self-reported history of seizures (any type) in the last 6 months

Related Conditions & MeSH terms

• Constriction, Pathologic
• Hemianopsia
• Homonymous Hemianopia
• Tunnel Vision
• Visual Field Constriction Bilateral
• Visual Field Defect Homonymous Bilateral
• Visual Field Defect, Peripheral

Intervention

Other:
• Field expansion view
Overlaid small window on HMD to show the part of the scene in the blind field into portions of the participants' remaining, seeing, field of vision

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	Response time	During the pedestrian detection task, average response time to the colliding pedestrian with and without prisms	Through study completion, an average of four months
Secondary	Head movement range	During the pedestrian detection task, lateral and vertical head movement range to check the head scanning range	Through study completion, an average of four months
Secondary	Walking speed	During the pedestrian detection task, the physical walking speed of the subject	Through study completion, an average of four months
Secondary	Pedestrian detection rate	Proportion of simulated pedestrians detected (in HMD walking)	Through study completion, an average of four months
Secondary	Error rate	Proportion of false alarms and missed targets to total targets	Through study completion, an average of four months