Zeiss CIRRUS HD-OCT 500, User Manual

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CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
Appendix
A-1
Appendix A: Normative Data Results
Overview
This chapter may be used in conjunction with the referenced analyses to provide normative
references for OCT results.
RNFL and Macula Normative Databases: Diversified
The CIRRUS HD-OCT RNFL and Macula Normative database contains normative data for
retinal nerve fiber layer (RNFL) and macular thickness from healthy subjects ages 19 to 84.
Seven centers participated in the 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. After undergoing a general
ophthalmic examination, qualifying and consented subjects underwent retinal scanning
with the CIRRUS HD-OCT instrument.
Medical and ophthalmic histories were taken prior to enrolling the subjects in the study.
Subjects were given a complete ophthalmic examination that included the following tests:
• Distance visual acuity.
• Perimetry using the Humphrey 24–2 SITA Standard threshold test, bilaterally. Any
defects found were verified with a second test.
• Goldmann applanation tonometry.
• Keratometry
• Axial length measurement using an IOLMaster.
• Slit lamp examination of the anterior segment of both eyes.
• Gonioscopy
• Dilated ophthalmoscopic examination, bilaterally.
• Fundus and stereodisc photography of the maculas and the optic nerves of both eyes.
• Corneal thickness measurement using ultrasound pachymetry.
Subjects were grouped into six categories, by subject age: 18–29, 30–39, 40–49, 50–59,
60–69, and 70 and older. Results in patients 70 years of age or older should be interpreted
with caution since only three subjects were included in the normative database who were
80 years of age or older, and only 28 subjects were included who were between 70 and 79
years of age.
It should also be noted that this normative database does not have any
subject younger than 19 years old.