Appendix2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User ManualC-2Post-LASIK groupSubjects who had undergone uncomplicated LASIK surgery for either myopia or hyperopiawithin 2 - 24 weeks prior to participating in the study.Exclusion CriteriaThe study exclusion criteria included subjects with a history of leukemia, AIDS,uncontrolled systemic hypertension, dementia or multiple sclerosis. The Normal Corneaand Post-LASIK groups also excluded subjects with blindness, low vision and/or severelydiseased eyes, whereas the Corneal Pathology group also excluded subjects with blindnessor low vision rendering the subject unable to fixate to keep gaze still enough to acquireimages. 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 thecornea in the study eye.• Presence of corneal pathology, either inflammatory or non-inflammatory, in the studyeye.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 stillenough to acquire images.Post-LASIK Group• Subjects who had undergone prior refractive and corneal surgery, except LASIK, in thestudy eye.• Subjects who had LASIK less than 2 weeks or more than 24 weeks prior to the day ofdata collection.• Presence of corneal pathology, either inflammatory or non-inflammatory, in the studyeye.• History of complicated LASIK surgery necessitating re-treatment and enhancements.Data AnalysisThe data was acquired and analyzed by a single operator on the Visante OCT and by threeoperators 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 asbetween CIRRUS 5000 and Visante OCT. The first qualified Visante OCT scan was used forcomparison with the first qualified CIRRUS 4000 and CIRRUS 5000 scan from any of thethree devices.The results of the repeatability and reproducibility analyses for the CIRRUS HD-OCT Model5000 from all three groups are provided in Tables 1 (Normal Cornea), 2 (CornealPathology), and 3 (Post-LASIK).
