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NCT Number: NCT05150197

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

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.

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Key information

Age range

4 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Nikita Piryani, MD

CONTACT

[email protected]

2624081232

Who can participate

Healthy volunteers accepted: Yes

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

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

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

Treatment and study plan

VisuALL

Device

Virtual Reality Visual Field Device

Humphrey Visual Field

Device

Standard of care Visual Field test

Primary outcomes

  1. Mean deviation results of visual field parameters

    Time frame: During office visit, approximately 30 minutes

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

  2. Pattern standard deviation results of visual field parameters

    Time frame: During office visit, approximately 30 minutes

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

  3. Sensitivity results of visual field parameters

    Time frame: During office visit, approximately 30 minutes

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

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

    Time frame: During office visit, approximately 5 minutes

    12 questions with strongly disagree to strongly agree

  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

    Time frame: During office visit, 30 minutes

    Home testing will be done in a few patients that demonstrate facility with the device

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon F Freedman, MD

CONTACT

[email protected]

(919) 681-3937

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Virtual Reality Visual Field Testing as an Alternative to Standard Automated Perimetry in Childhood Eye Disease

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Dec 9, 2021
Registry last updated
May 26, 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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