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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04175444

Collaborator

(none)

Enrollment

Location

29.5

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Visual Field Defect, Peripheral	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 Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 15, 2020

Actual Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

Principal Investigator: Sylvia Groth, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sylvia L. Groth, MD, Assistant Professor of Ophthalmology, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT04175444

Other Study ID Numbers:

000000001

First Posted:

Nov 25, 2019

Last Update Posted:

Mar 3, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Study Results

No Results Posted as of Mar 3, 2022