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

Completed

• Conditions: Visual Field Defect, Peripheral
• Interventions: Diagnostic Test: VisuALL Field Analyzer; Diagnostic Test: Humphrey Field Analyzer

• Registration Number: NCT04175444
• Lead Sponsor: Vanderbilt University Medical Center

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-25
• Study Start: 2020-06-15
• Primary Completion: 2020-07-01
• Study Completion: 2022-12-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Subjects	VisuALL Field Analyzer	This is a study of normal subjects to establish a normative database.
Normal Subjects	Humphrey Field Analyzer	This is a study of normal subjects to establish a normative database.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Frequency of seeing curves	End of the recruitment phase, average 3 months	Establish frequency of seeing curves with the head mounted device
Ease of device use	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States