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

Visual Field Defect, Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175444
• Other study ID #: 000000001
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Visual Field Defect, Peripheral

Intervention

Diagnostic Test:
• VisuALL Field Analyzer
Each participant will conduct a visual field test with the visuaALL headset.
• Humphrey Field Analyzer
Each participant will conduct a standard of care Humphrey Visual Field.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal sensitivity	Retinal sensitivity at each location and compared between the two test strategies	End of the recruitment phase, average 3 months
Primary	Mean retinal sensitivity	Mean retinal sensitivity at each quadrants and each hemifield	End of the recruitment phase, average 3 months
Secondary	Frequency of seeing curves	Establish frequency of seeing curves with the head mounted device	End of the recruitment phase, average 3 months
Secondary	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