visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry

Study Overview
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Brief Summary
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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
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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.

Official Title
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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?

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer
* Diagnostic Test: visuALL Field Analyzer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Controls<br>Healthy subjects between 21 and 80 years of age with no eye diseases (normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal and reliable standard automatic perimetry, and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field. | Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer<br>* Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.<br>* Other names: SAP HFA;Diagnostic Test: visuALL Field Analyzer<br>* visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.<br>* Other names: vFA;|
| Experimental: Mild and Moderate Glaucoma<br>Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have a reliable standard automatic perimetry with no more than -6 mean deviation (Mild) and between -6 mean and -12 mean deviation (Moderate). Spherical refraction will be less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field. | Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer<br>* Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.<br>* Other names: SAP HFA;Diagnostic Test: visuALL Field Analyzer<br>* visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.<br>* Other names: vFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Retinal Sensitivity From Two Machines | Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision. | three hours | 
| Global Correlation (Agreement Between Two Machines in the Overall Visual Field) | Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines. | three hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field) | Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the inferior nasal visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the inferior (lower) nasal portion of the visual field, between two testing machines. | three hours | 
| Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field | Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the superior (upper) hemifield portion of the visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field in the superior hemifield, between two testing machines. | three hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open angle glaucoma, visual field, Standard Automatic Perimetry