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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04175444
Enrollment
50
Registered
2019-11-25
Start date
2020-06-15
Completion date
2022-12-01
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Field Defect, Peripheral

Brief 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

Interventions

DIAGNOSTIC_TESTVisuALL Field Analyzer

Each participant will conduct a visual field test with the visuaALL headset.

DIAGNOSTIC_TESTHumphrey Field Analyzer

Each participant will conduct a standard of care Humphrey Visual Field.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* No history of intraocular surgery * Best corrected visual acuity (BVCA) 20/25 or better in each eye

Exclusion criteria

* A spherical refraction outside ± 5.0 D and cylinder correction outside 2.0 D. * Intraocular surgery in the study eye * History of systemic condition known to affect visual function. * History of medication known to affect visual function.

Design outcomes

Primary

MeasureTime frameDescription
Retinal sensitivityEnd of the recruitment phase, average 3 monthsRetinal sensitivity at each location and compared between the two test strategies
Mean retinal sensitivityEnd of the recruitment phase, average 3 monthsMean retinal sensitivity at each quadrants and each hemifield

Secondary

MeasureTime frameDescription
Frequency of seeing curvesEnd of the recruitment phase, average 3 monthsEstablish frequency of seeing curves with the head mounted device
Ease of device useEnd of the recruitment phase, average 3 monthsPatients will be given a short survey asking about ease of device use, 2 questions on 1-5 scale with 1 being the least and 5 being the most.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026