Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking

• Sponsor: Massachusetts Eye and Ear Infirmary (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05141604
• Collaborator: National Eye Institute (NEI) (NIH)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 25.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hemianopsia; Homonymous Hemianopia; Tunnel Vision; Visual Field Defect, Peripheral; Visual Field Constriction Bilateral; Visual Field Defect Homonymous Bilateral	Other: Field expansion view	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Monocular Visual Confusion for Field Expansion
• Actual Study Start Date: May 17, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pedestrian detection rate [Through study completion, an average of four months]

   Proportion of simulated pedestrians detected (in HMD walking)

Secondary Outcome Measures

1. Head movement range [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 [Through study completion, an average of four months]

   During the task, the physical walking speed of the subject

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• Inclusion/Exclusion Criteria Inclusion criteria - Common

• 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)

Inclusion criteria - subjects with visual field loss

• 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

Inclusion criteria - subjects with normal vision

• No restrictions of the peripheral visual field: (> 60 degrees diameter)

• Better than 20/40 visual acuity in the worse eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schepens Eye Research Institute	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts Eye and Ear Infirmary
• National Eye Institute (NEI)

Investigators

• Principal Investigator: Jaehyun Jung, PhD, Assistant Scientist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaehyun Jung, Assistant Scientist, Massachusetts Eye and Ear Infirmary
• ClinicalTrials.gov Identifier: NCT05141604
• Other Study ID Numbers: 2021P003330; R01EY031777
• First Posted: Dec 2, 2021
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jaehyun Jung, Assistant Scientist, Massachusetts Eye and Ear Infirmary: walking; collision; field expansion; visual field loss
• Additional relevant MeSH terms: Hemianopsia

Study Results

No Results Posted as of May 24, 2022