Recruiting

VisuALL vs. HVF

Sponsor:

Duke University

Code:

NCT05150197

Conditions

Visual Field Defect, Peripheral

Eligibility Criteria

Sex: All

Age: 4 - 21

Healthy Volunteers: Accepted

Interventions

VisuALL

Humphrey Visual Field

Study Details

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.

Conditions

Visual Field Defect, Peripheral

Study ID

NCT05150197

Start date

Jan 19, 2022

Status verified date

May, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 21

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

other: Control group

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

Interventions

VisuALL

Virtual Reality Visual Field Device

Humphrey Visual Field

Standard of care Visual Field test

Primary outcome measure

  • Mean deviation results of visual field parameters [ Time Frame: During office visit, approximately 30 minutes ]
  • Pattern standard deviation results of visual field parameters [ Time Frame: During office visit, approximately 30 minutes ]
  • Sensitivity results of visual field parameters [ Time Frame: During office visit, approximately 30 minutes ]

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

More Information

Sponsor

Duke University

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Virtual Reality Visual Field
  • Glaucoma
  • Neuro-ophthalmology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-26.