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

NCT04175444 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-08-29

No results posted yet for this study

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).

Conditions

  • Visual Field Defect, Peripheral

Interventions

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Sylvia Groth, MD · Vanderbilt University Medical Center

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2020-07-01
Completion
2022-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04175444 on ClinicalTrials.gov