Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking

Monocular Visual Confusion for Field Expansion

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.

Study Overview

• Status: Recruiting
• Conditions: Tunnel Vision; Visual Field Defect, Peripheral; Visual Field Constriction Bilateral; Visual Field Defect Homonymous Bilateral; Hemianopsia; Homonymous Hemianopia
• Intervention / Treatment: Other: Field expansion view

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandhya Shekar; Phone Number: 6179122522; Email: sandhya_shekar@meei.harvard.edu
• Study Contact Backup: Name: Eli Peli, OD, MSc; Phone Number: 6179122597; Email: eli_peli@meei.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Schepens Eye Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Field expansion view; Various configurations of field expansion views will be additionally displayed on HMD	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pedestrian detection rate	Proportion of simulated pedestrians detected (in HMD walking)	Through study completion, an average of four months
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
Walking speed	During the pedestrian detection task, the physical walking speed of the subject	Through study completion, an average of four months
Error rate	Proportion of false alarms and missed targets to total targets	Through study completion, an average of four months

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Eli Peli, OD, MSc, Senior Scientist

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: walking; collision; field expansion; visual field loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Pathological Conditions, Anatomical; Sensation Disorders; Vision Disorders; Blindness; Constriction, Pathologic; Hemianopsia
• Other Study ID Numbers: 2021P003330; R01EY031777 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No