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SITA Normative and GPA Databases
Humphrey Field Analyzer II-
i
series User Manual 2660021145640 A
K-4
SITA-SWAP Database
The SITA-SWAP normative database was collected at a separate time and at different sites than the
SITA and GPA databases. Four centers contributed normal data in this prospective, non-randomized,
multi-center study. SITA-SWAP 24-2 threshold visual field test results were collected from healthy
subjects aged 18 to 80. Enrolled subjects were representative of healthy individuals with no history
of eye disease and were carefully screened and evaluated for eligibility (see exclusion criteria
below). After undergoing a general ophthalmic examination, qualifying and consenting subjects
underwent multiple visual field tests over a period of two 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 tests listed in the SITA collection
previously, along with these additional tests:
• Color vision testing.
• LOCS (Lens Opacities Classification System) II grading of crystalline lens through a dilated pupil.
The inclusion and exclusion criteria for the SITA and SITA-SWAP normative database studies were as
follows:
Inclusion Criteria
• Males or females over the age of consent in the country in which the testing was done, or had
clear parental consent (SITA-SWAP: 18 years of age or older).
• Able and willing to make the required study visits.
• Able and willing to give consent and follow study instructions.
Exclusion Criteria
• History of amblyopia.
• Pressure of more than 22 mm Hg in either eye.
• Corrected visual acuity less than 20/30 in either eye if age 50 or older and less than 20/25 in
either eye if under age 50 (For SITA-SWAP: Visual acuity worse than 20/30 in either eye).
• Refractive error in either eye exceeding 5 diopters spherical equivalent or 2.5 diopters cylinder.
• Suspicious or pathologic optic discs.
• Visual field defect or suspicion of a visual field defect in the tested eye that was explained by
ocular status or history.
• Previous or current significant eye disease in the tested eye, significant eye trauma or
intraocular surgery, or the presence of ocular findings that could affect the visual field.
• Diagnosis in either eye of glaucoma or other disease that might affect the likelihood of
normality of the visual field in the tested eye.
• Abnormal pupil, or history of use of pilocarpine or other medication, or history of disease that
might have been affecting pupil size or reactivity.
• Any systemic disease, or history of treatment with medications, e.g. plaquenil, any of which
may be expected to affect the visual field.
• History of stroke, insulin dependent diabetes, or diabetic retinopathy.
• Inability to undergo the visual field test.
Both eyes were required to have passed the criteria above for the subject to be entered into either
study. If one eye qualified and one eye was excluded, the subject and both eyes were excluded.