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

NCT ID: NCT04175444

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-12-01

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

Conditions

Visual Field Defect, Peripheral

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Normal Subjects

This is a study of normal subjects to establish a normative database.

VisuALL Field Analyzer

Intervention Type: DIAGNOSTIC_TEST

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

Humphrey Field Analyzer

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

VisuALL Field Analyzer

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

Intervention Type: DIAGNOSTIC_TEST

Humphrey Field Analyzer

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

visual field testing strategy, head mounted device, Olleyes; standard of care visual field test

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sylvia L. Groth, MD

Assistant Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sylvia Groth, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

000000001

Identifier Type: -

Identifier Source: org_study_id