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

NCT04175444 | Completed FDA Device

• 1 other identifier: 000000001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Visual Field Defect, Peripheral

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Frequency of seeing curves

  End of the recruitment phase, average 3 months

• Ease of device use

  End of the recruitment phase, average 3 months

Study Arms (1)

Normal Subjects

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

Diagnostic Test: VisuALL Field Analyzer; Diagnostic Test: Humphrey Field Analyzer

Interventions

VisuALL Field Analyzer DIAGNOSTIC_TEST

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

Also known as: visual field testing strategy, head mounted device, Olleyes

Normal Subjects

Humphrey Field Analyzer DIAGNOSTIC_TEST

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

Also known as: standard of care visual field test

Normal Subjects

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

• Sylvia Groth, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 25, 2019
• Study Start: June 15, 2020
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2022
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)