Clinical trial NCT03804684: visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Keywords: open angle glaucoma
visual field
Standard Automatic Perimetry
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Olleyes, Inc.
First posted: 2019-01-15
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Standard Automatic Perimetry (SAP).

Detailed description: Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucoma. The current device has its own limitation such as positioning for the duration of the test which makes is hard for older patients especially those with back or other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the patients refractive errors, etc.

Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient comfort.

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 comparison of the measured parameters with HFA.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Retinal Sensitivity From Two Machines
timeFrame: three hours
measure: Global Correlation (Agreement Between Two Machines in the Overall Visual Field)
timeFrame: three hours
Secondary outcomes:
measure: Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)
timeFrame: three hours
measure: Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field
timeFrame: three hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye
name: M Reza Razeghinejad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097/IJG.0000000000001670.