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RecruitingNCT05150197Updated May 26, 2026

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

An interventional study of VisuALL and Humphrey Visual Field in Visual Field Defect, Peripheral, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 4 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Duke University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jan 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Non-randomized
Ages
4 Years to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Visual Field Defect, Peripheral

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Keywords

  • Virtual Reality Visual Field
  • Glaucoma
  • Neuro-ophthalmology
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients must be at least four (4) years old
  • 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

Exclusion Criteria:

  • Developmental delay
  • Inability to obtain consent
  • Inability to understand English
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Patient (pathology) group

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

    Device: VisuALL · Device: Humphrey Visual Field

  • Other
    Control group

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

    Device: VisuALL

Interventions

  • DeviceVisuALL

    Virtual Reality Visual Field Device

  • DeviceHumphrey Visual Field

    Standard of care Visual Field test

06

What researchers measure

Primary outcomes

  1. Mean deviation results of visual field parameters

    Mean deviation of the visual field is one score measured in decibels calculated from device reading

    Time frame: During office visit, approximately 30 minutes

  2. Pattern standard deviation results of visual field parameters

    Pattern standard deviation of the visual field is one score calculated from device reading

    Time frame: During office visit, approximately 30 minutes

  3. Sensitivity results of visual field parameters

    Sensitivities are the results of each space in the visual field measured in decibels

    Time frame: During office visit, approximately 30 minutes

Secondary outcomes

  1. Percent of times that scotomas were visualized as measured by visual field tests

    Time frame: During office visit, approximately 30 minutes

  2. Percent of participants stating satisfaction as measured by questionnaire

    12 questions with strongly disagree to strongly agree

    Time frame: During office visit, approximately 5 minutes

  3. Percent of patients able to use VisuALL in-office testing as measured by patient observation

    Time frame: During office visit, approximately 30 minutes

  4. 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 the device

    Time frame: During office visit, 30 minutes

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Study locations

1 of 1 sites recruiting
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32941320 ↗
  • 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. PubMed 34003954 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05150197
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Dec 9, 2021
Start date
Jan 19, 2022
Primary completion
Jun 1, 2028 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
May 26, 2026

Study contacts

Sharon F Freedman, MD
Contact
sharon.freedman@duke.edu
(919) 681-3937
Sharon F Freedman, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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