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Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking

Primary Purpose

Hemianopsia, Homonymous Hemianopia, Tunnel Vision

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Field expansion view
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hemianopsia focused on measuring walking, collision, field expansion, visual field loss

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

• 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

Sites / Locations

  • Schepens Eye Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Field expansion view

Arm Description

Various configurations of field expansion views will be additionally displayed on HMD

Outcomes

Primary Outcome Measures

Pedestrian detection rate
Proportion of simulated pedestrians detected (in HMD walking)

Secondary Outcome Measures

Head movement range
During the pedestrian detection task, lateral and vertical head movement range to check the head scanning range
Walking speed
During the task, the physical walking speed of the subject

Full Information

First Posted
November 19, 2021
Last Updated
July 12, 2023
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT05141604
Brief Title
Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking
Official Title
Monocular Visual Confusion for Field Expansion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemianopsia, Homonymous Hemianopia, Tunnel Vision, Visual Field Defect, Peripheral, Visual Field Constriction Bilateral, Visual Field Defect Homonymous Bilateral
Keywords
walking, collision, field expansion, visual field loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Field expansion view
Arm Type
Experimental
Arm Description
Various configurations of field expansion views will be additionally displayed on HMD
Intervention Type
Other
Intervention Name(s)
Field expansion view
Intervention Description
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 Outcome Measure Information:
Title
Pedestrian detection rate
Description
Proportion of simulated pedestrians detected (in HMD walking)
Time Frame
Through study completion, an average of four months
Secondary Outcome Measure Information:
Title
Head movement range
Description
During the pedestrian detection task, lateral and vertical head movement range to check the head scanning range
Time Frame
Through study completion, an average of four months
Title
Walking speed
Description
During the task, the physical walking speed of the subject
Time Frame
Through study completion, an average of four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
• 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandhya Shekar
Phone
6179122522
Email
sandhya_shekar@meei.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jaehyun Jung, PhD
Phone
6179122525
Email
jaehyun_jung@meei.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaehyun Jung, PhD
Organizational Affiliation
Assistant Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schepens Eye Research Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking

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