Zeiss CIRRUS HD-OCT 500, Руководство пользователя

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Appendix
2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
A-2
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.
• Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo–retinal
disease.
Systemic
• History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia or
multiple sclerosis.
• A life threatening or debilitating disease.
• Current or recent (within the past 14 days) use of an agent with photosensitizing
properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline, etc.).
Normal subjects were defined by Principal Investigators at each site after review of clinical
and visual field data, and considering inclusion and exclusion criteria. The CIRRUS
instrument was not used in determining the normalcy of the subjects.
The subjects were defined as normal if they met the following criteria:
• Best corrected visual acuity of 20/40 or better in both eyes.
• IOP less than or equal to 21 mm Hg.
• No history of ocular, neurological, or systemic diseases that might affect the visual
system.