NCT04175444

Establishing a Normative Database in Pediatric Population of the Head-mounted visuALL Field Analyzer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to determine reference values of the VisuALL Field Test in pediatric population. Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of different diseases of the visual pathway like glaucoma. Its main goal is to measure the differential light sensitivity at several locations in the central field of vision. Nevertheless, the accuracy of the current devices is limited by several factors such as the inherent inconsistency of the psychophysical test, stressful examinations and frequency of testing. Several devices have been developed since the advent of the Octopus Perimeter and the Humphrey Field Analyzer (HFA) in an effort to improve the early detection of glaucoma. Several of these visual field test variants are implemented using laptops, iPads, and virtual reality headsets. These modalities bring portability but lack fixation methods, environmental control, and hardware standardization. These deficiencies may limit their wide usage. The main goal of this study is to develop an initial pediatric reference database of a novel visual field test ecosystem that takes advantage of a Head Mounted Device (HMD).

Detailed description

This is a cross-sectional observational study. The primary endpoint of the study will be at the end of the recruitment phase. * Participants that qualify for the study will be invited to a clinical site of the Vanderbilt Eye Institute or equivalent testing space and best corrected visual acuity will be checked with standard Snellen Acuity chart. * Once vision is confirmed to meet study requirements, the child will be instructed on how to use the headset. * The test will be generated and participant will complete various testing strategies including suprathreshold, full threshold and individual point testing and possibly other strategies for frequency of seeing curves. * Patient with pathology may be confirmed with formal standard of care visual field testing * Short survey will be administered to inquire on ease of device use * Data will be submitted for analysis

Conditions

• Visual Field Defect, Peripheral

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	VisuALL Field Analyzer	Each participant will conduct a visual field test with the visuaALL headset.
DIAGNOSTIC_TEST	Humphrey Field Analyzer	Each participant will conduct a standard of care Humphrey Visual Field.

Timeline

• Start date: 2020-06-15
• Primary completion: 2020-07-01
• Completion: 2022-12-01
• First posted: 2019-11-25
• Last updated: 2023-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study