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OpenTrials
Active, Not Recruiting

NCT Number: NCT05141604

Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hemianopsia Blindness Eye Diseases Homonymous Hemianopia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tunnel Vision Vision Disorders Visual Field Constriction Bilateral Visual Field Defect Homonymous Bilateral Visual Field Defect, Peripheral

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schepens Eye Research Institute

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Field expansion view

Other

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

Primary outcomes

  1. Response time

    Time frame: Through study completion, an average of four months

    During the pedestrian detection task, average response time to the colliding pedestrian with and without prisms

Secondary outcomes

  1. Head movement range

    Time frame: Through study completion, an average of four months

    During the pedestrian detection task, lateral and vertical head movement range to check the head scanning range

  2. Walking speed

    Time frame: Through study completion, an average of four months

    During the pedestrian detection task, the physical walking speed of the subject

  3. Pedestrian detection rate

    Time frame: Through study completion, an average of four months

    Proportion of simulated pedestrians detected (in HMD walking)

  4. Error rate

    Time frame: Through study completion, an average of four months

    Proportion of false alarms and missed targets to total targets

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Monocular Visual Confusion for Field Expansion

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Dec 2, 2021
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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