Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04175444 |
Other study ID # |
000000001 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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