visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry
NCT ID: NCT03804684
Last Updated: 2022-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2019-01-08
2020-10-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy Controls
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.
Standard Automatic Perimetry Humphrey Field Analyzer
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.
visuALL Field Analyzer
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.
Mild and Moderate Glaucoma
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.
Standard Automatic Perimetry Humphrey Field Analyzer
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.
visuALL Field Analyzer
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.
Interventions
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Standard Automatic Perimetry Humphrey Field Analyzer
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.
visuALL Field Analyzer
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
80 Years
ALL
Yes
Sponsors
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Olleyes, Inc.
INDUSTRY
Wills Eye
OTHER
Responsible Party
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M. Reza Razeghinejad MD
Principal Investigator
Principal Investigators
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M Reza Razeghinejad, MD
Role: PRINCIPAL_INVESTIGATOR
Wills Eye
Locations
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Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB Control #18-768E
Identifier Type: -
Identifier Source: org_study_id
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