visuALL Field Analyzer (vFA) Compared to Standard Automatic Perimetry



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:21 - 80
Updated:1/17/2019
Start Date:January 8, 2019
End Date:December 31, 2019
Contact:Jeanne Molineaux, COA
Email:jmolineaux@willseye.org
Phone:215-825-4713

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How Does the visuALL Field Analyzer (vFA) Compare to Standard Automatic Perimetry (SAP) in Patients With Mild and Moderate Chronic Open Angle Glaucoma (COAG) and Subjects Without Eye Problems?

To determine age-adjusted reference values of the visuALL Field Analyzer (vFA), to assess the
repeatability for each parameter and correlate them with a Standard Automatic Perimetry (SAP)
parameters.

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 of the central and peripheral field of vision.
Nevertheless, the accuracy of the current device is limited by several factors like the
inherent inconsistency of the psychophysical test, stressful examinations and frequency of
testing among others.

Several devices have been developed since the advent of the Octopus Perimeter3-5 and the
Humphrey Field Analyzer (HFA), in an effort to improve early detection of glaucoma.

The main goal of this study is to evaluate the repeatability of a novel psychophysical
platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities.
Other objectives of this study include the development of an initial reference database and
the evaluation of its correlation with HFA parameters.

Inclusion Criteria:

- age 21 to 80 years

- Healthy subjects with no eye diseases, normal appearing optic nerve and retina,
intraocular pressure less than 19 millimeters mercury and normal standard automatic
perimetry (SAP).

- mild glaucoma subjects with less than -6 mean deviation

- moderate glaucoma subjects with -6 to -12 mean deviation

Exclusion Criteria:

- spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0
diopters

- Unreliable SAP (false positives, fixation losses and false negatives greater than 25%
and/or observable testing artifacts)

- Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive
fixation losses)

- SAP abnormality with pattern loss consistent with neurologic and/or other ocular
diseases than glaucoma

- Intraocular surgery in study eye (except non-complicated cataract or refractive
surgery performed more than 6 months before enrollment and without posterior capsule
opacification)

- History of systemic condition known to affect visual function

- History of medication known to affect visual function
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Philadelphia, Pennsylvania 19107
Phone: 215-825-4713
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