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Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease

Primary Purpose

Visual Field Defect, Peripheral

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VisuALL
Humphrey Visual Field
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Visual Field Defect, Peripheral focused on measuring Virtual Reality Visual Field, Glaucoma, Neuro-ophthalmology

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients must be 17 years or younger, OR patients from 18-21 years of age must have been diagnosed with their condition prior to their 18th birthday
  • Cognitively normal (no developmental delay or syndrome)
  • Be able to tolerate wearing the virtual reality goggles for at least 10 minutes
  • Be able to provide informed consent of a parent/guardian (and assent if 12 years or older)
  • Do not have any ocular diseases that could interfere with the visual field testing

Exclusion Criteria:

  • Developmental delay
  • Inability to obtain consent
  • Inability to understand English

Sites / Locations

  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patient (pathology) group

Control group

Arm Description

This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.

This group will only perform the VisuALL Virtual Reality Visual Field.

Outcomes

Primary Outcome Measures

Mean deviation results of visual field parameters
Mean deviation of the visual field is one score measured in decibels calculated from device reading
Pattern standard deviation results of visual field parameters
Pattern standard deviation of the visual field is one score calculated from device reading
Sensitivity results of visual field parameters
Sensitivities are the results of each space in the visual field measured in decibels

Secondary Outcome Measures

Percent of times that scotomas were visualized as measured by visual field tests
Percent of participants stating satisfaction as measured by questionnaire
12 questions with strongly disagree to strongly agree
Percent of patients able to use VisuALL home testing as measured by device reading
Home testing will be done in a few patients that demonstrate facility with device
Percent of patients able to use VisuALL in-office testing as measured by patient observation

Full Information

First Posted
November 17, 2021
Last Updated
February 20, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05150197
Brief Title
Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease
Official Title
Virtual Reality Visual Field Testing as an Alternative to Standard Automated Perimetry in Childhood Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
January 19, 2024 (Anticipated)
Study Completion Date
January 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test. The study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants. Selected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Field Defect, Peripheral
Keywords
Virtual Reality Visual Field, Glaucoma, Neuro-ophthalmology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient (pathology) group
Arm Type
Experimental
Arm Description
This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.
Arm Title
Control group
Arm Type
Other
Arm Description
This group will only perform the VisuALL Virtual Reality Visual Field.
Intervention Type
Device
Intervention Name(s)
VisuALL
Intervention Description
Virtual Reality Visual Field Device
Intervention Type
Device
Intervention Name(s)
Humphrey Visual Field
Intervention Description
Standard of care Visual Field test
Primary Outcome Measure Information:
Title
Mean deviation results of visual field parameters
Description
Mean deviation of the visual field is one score measured in decibels calculated from device reading
Time Frame
During office visit, approximately 30 minutes
Title
Pattern standard deviation results of visual field parameters
Description
Pattern standard deviation of the visual field is one score calculated from device reading
Time Frame
During office visit, approximately 30 minutes
Title
Sensitivity results of visual field parameters
Description
Sensitivities are the results of each space in the visual field measured in decibels
Time Frame
During office visit, approximately 30 minutes
Secondary Outcome Measure Information:
Title
Percent of times that scotomas were visualized as measured by visual field tests
Time Frame
During office visit, approximately 30 minutes
Title
Percent of participants stating satisfaction as measured by questionnaire
Description
12 questions with strongly disagree to strongly agree
Time Frame
During office visit, approximately 5 minutes
Title
Percent of patients able to use VisuALL home testing as measured by device reading
Description
Home testing will be done in a few patients that demonstrate facility with device
Time Frame
One month, 1-2 tests per week
Title
Percent of patients able to use VisuALL in-office testing as measured by patient observation
Time Frame
During office visit, approximately 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients must be 17 years or younger, OR patients from 18-21 years of age must have been diagnosed with their condition prior to their 18th birthday Cognitively normal (no developmental delay or syndrome) Be able to tolerate wearing the virtual reality goggles for at least 10 minutes Be able to provide informed consent of a parent/guardian (and assent if 12 years or older) Do not have any ocular diseases that could interfere with the visual field testing Exclusion Criteria: Developmental delay Inability to obtain consent Inability to understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel A Alvarez, MD
Phone
919-684-0560
Email
samuel.alvarez544@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon F Freedman, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel A Alvarez-Falcon, MD
Phone
919-684-0560
Email
samuel.alvarez544@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32941320
Citation
Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097/IJG.0000000000001670.
Results Reference
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PubMed Identifier
34003954
Citation
Montelongo M, Gonzalez A, Morgenstern F, Donahue SP, Groth SL. A Virtual Reality-Based Automated Perimeter, Device, and Pilot Study. Transl Vis Sci Technol. 2021 Mar 1;10(3):20. doi: 10.1167/tvst.10.3.20.
Results Reference
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Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease

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