Zeiss CIRRUS HD-OCT 500, User Manual

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Appendix
2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
C-2
Post-LASIK group
Subjects who had undergone uncomplicated LASIK surgery for either myopia or hyperopia
within 2 - 24 weeks prior to participating in the study.
Exclusion Criteria
The study exclusion criteria included subjects with a history of leukemia, AIDS,
uncontrolled systemic hypertension, dementia or multiple sclerosis. The Normal Cornea
and Post-LASIK groups also excluded subjects with blindness, low vision and/or severely
diseased eyes, whereas the Corneal Pathology group also excluded subjects with blindness
or low vision rendering the subject unable to fixate to keep gaze still enough to acquire
images. The following exclusion criteria were applicable to their respective group:
Normal Cornea Group
• Subjects who had undergone prior surgery or a procedure involving or affecting the
cornea in the study eye.
• Presence of corneal pathology, either inflammatory or non-inflammatory, in the study
eye.
Corneal Pathology Group
• Subjects with normal corneas in the study eye.
• Subjects who had undergone LASIK in the study eye.
• Blindness or low vision rendering the subject unable to fixate to keep gaze still
enough to acquire images.
Post-LASIK Group
• Subjects who had undergone prior refractive and corneal surgery, except LASIK, in the
study eye.
• Subjects who had LASIK less than 2 weeks or more than 24 weeks prior to the day of
data collection.
• Presence of corneal pathology, either inflammatory or non-inflammatory, in the study
eye.
• History of complicated LASIK surgery necessitating re-treatment and enhancements.
Data Analysis
The data was acquired and analyzed by a single operator on the Visante OCT and by three
operators on three CIRRUS HD-OCT 4000 and three CIRRUS HD-OCT 5000 devices.
Measurements were compared between CIRRUS HD-OCT 4000 and Visante OCT as well as
between CIRRUS 5000 and Visante OCT. The first qualified Visante OCT scan was used for
comparison with the first qualified CIRRUS 4000 and CIRRUS 5000 scan from any of the
three devices.
The results of the repeatability and reproducibility analyses for the CIRRUS HD-OCT Model
5000 from all three groups are provided in Tables 1 (Normal Cornea), 2 (Corneal
Pathology), and 3 (Post-LASIK).