CIRRUS HD-OCT User Manual
2660021169012 Rev. A 2017-12
Appendix
A-25
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 application 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 70–80. It should be noted that this normative database does not have any
subject younger than 19 years old or older than 79 years old.
Inclusion and Exclusion Criteria
Inclusion and exclusion criteria for enrollment in the study were as follows:
Inclusion Criteria
• Males or females 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.
• Must have a normal and valid Humphrey 24–2 SITA Standard visual field in both eyes.
Exclusion Criteria
Ophthalmic:
• Best corrected visual acuity in either eye worse than 20/40.
• Refractive error (spherical equivalent) outside –12.00 D to +8.00 D range.
• Glaucoma or glaucoma suspect diagnosis in either eye.
• Presence or history of ocular hypertension (IOP
≥
22 mm Hg) in either eye.
• Occludable angle or history of angle closure in either eye.
• Presence or history of disc hemorrhage in either eye.
• Presence of RNFL defect in either eye.
• Presence of amblyopia in either eye.
• Previous laser or incisional surgery.
• Any active infection of anterior or posterior segments.
Summary of Contents for CIRRUS HD-OCT 500
Page 1: ...2660021156446 B2660021156446 B CIRRUS HD OCT User Manual Models 500 5000 ...
Page 32: ...User Documentation 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 2 6 ...
Page 44: ...Software 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 3 12 ...
Page 58: ...User Login Logout 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 4 14 ...
Page 72: ...Patient Preparation 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 5 14 ...
Page 110: ...Tracking and Repeat Scans 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 6 38 ...
Page 122: ...Criteria for Image Acceptance 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 7 12 ...
Page 222: ...Overview 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 9 28 ...
Page 256: ...Log Files 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 11 18 ...
Page 308: ...Appendix 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual A 34 ...
Page 350: ...CIRRUS HD OCT User Manual 2660021169012 Rev A 2017 12 I 8 ...
Page 351: ...CIRRUS HD OCT User Manual 2660021169012 Rev A 2017 12 ...