Zeiss Humphrey II-i series, Руководство пользователя

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Humphrey Field Analyzer II-
i
series User Manual 2660021145640 A
SITA Normative and GPA Databases K-3
Normative and GPA Database Collection and Demographics
Introduction
The Humphrey Field Analyzer contains multiple normative databases that provide data for statistical
comparison of how your patient's visual field results compare to an age-matched population. SITA
Standard threshold test results are compared to one normative database, SITA Fast results to
another. When a patient performs a blue-yellow perimetry test, the SITA Short-Wavelength
Automated Perimetry (SWAP) normative database is used for reference. GPA uses two databases.
The normative database (either SITA Standard or SITA Fast) appropriate for the particular test is used
to generate the VFI value that is used in trend analysis, and a separate database (GPA) of short-term
reproducibility data from subjects with glaucoma is used to determine when change exceeds
expected test-retest variability. These databases were collected over a significant amount of time
and involved hundreds of subjects. The following information discusses the collection of data and
the demographics of the subjects qualified for the creation of these databases.
Subjects were recruited and enrolled at each site by the method approved by either an Institutional
Review Board (IRB) or an Ethics Committee. Each site bore responsibility for satisfying all local IRB
or Ethics Committee requirements, as well as for obtaining informed consent according to local
requirements.
SITA and SITA-SWAP Normative Databases
Subjects that were considered normal were recruited for both the SITA and SITA-SWAP normative
databases. Furthermore, the SITA normative study collected data that went into the creation of two
databases: the SITA Standard and the SITA Fast databases. The same subjects were tested with both
the SITA Standard and the SITA Fast threshold algorithms.
SITA Database
The SITA normative database contains normative data for SITA Standard and SITA Fast 30-2, 24-2,
and 10-2 threshold visual field test results from healthy subjects ages 17 to 89. Ten centers
contributed normative data in this prospective, non-randomized, multi-center study. Enrolled
subjects were representative of healthy individuals with no history of eye disease and were carefully
screened and evaluated for eligibility (see exclusion criteria). After undergoing a general ophthalmic
examination, qualifying and consenting subjects underwent multiple visual field tests over a period
of three visits.
Medical and ophthalmic histories were taken prior to qualifying the subjects into the study. Subjects
were given a complete ophthalmic examination that included the following tests:
• Distance visual acuity.
• Slit lamp examination of the anterior segment of both eyes.
• Goldmann applanation tonometry.
• Dilated ophthalmoscopic examination, bilaterally.
• Fundus photography that included the macula and the optic nerve of each eye.