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OpenTrials
Completed

NCT Number: NCT04175444

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

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).

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Key information

Conditions

Visual Field Defect, Peripheral

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

VisuALL Field Analyzer

Diagnostic Test

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

Other names: visual field testing strategy, head mounted device, Olleyes

Humphrey Field Analyzer

Diagnostic Test

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

Other names: standard of care visual field test

Primary outcomes

  1. Retinal sensitivity

    Time frame: End of the recruitment phase, average 3 months

    Retinal sensitivity at each location and compared between the two test strategies

  2. Mean retinal sensitivity

    Time frame: End of the recruitment phase, average 3 months

    Mean retinal sensitivity at each quadrants and each hemifield

Secondary outcomes

  1. Frequency of seeing curves

    Time frame: End of the recruitment phase, average 3 months

    Establish frequency of seeing curves with the head mounted device

  2. Ease of device use

    Time frame: End of the recruitment phase, average 3 months

    Patients 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Nov 25, 2019
Registry last updated
Aug 29, 2023

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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