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).

Study Overview

• Status: Completed
• Conditions: Visual Field Defect, Peripheral
• Intervention / Treatment: Diagnostic test: VisuALL Field Analyzer; Diagnostic test: Humphrey Field Analyzer

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

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Population will be healthy children recruited. All ethnicities will be included and both genders.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Subjects; This is a study of normal subjects to establish a normative database.	Diagnostic test: VisuALL Field Analyzer; Each participant will conduct a visual field test with the visuaALL headset.; Other Names: visual field testing strategy, head mounted device, Olleyes; Diagnostic test: Humphrey Field Analyzer; Each participant will conduct a standard of care Humphrey Visual Field.; Other Names: standard of care visual field test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal sensitivity	Retinal sensitivity at each location and compared between the two test strategies	End of the recruitment phase, average 3 months
Mean retinal sensitivity	Mean retinal sensitivity at each quadrants and each hemifield	End of the recruitment phase, average 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of seeing curves	Establish frequency of seeing curves with the head mounted device	End of the recruitment phase, average 3 months
Ease of device use	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.	End of the recruitment phase, average 3 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Sylvia Groth, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 000000001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planning to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes