Agreement and Precision Study of the Nidek Mirante

Inclusion Criteria - Normal Group:

• Male or female subjects from 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
• Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
• Subjects who agree to participate in the study;
• Subjects with normal eye examinations (without pathology other than cataract) in both eyes on the date of the study visit as observed with a +90 Diopter Fundus Lens;
• Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or better in both eyes on the date the study visit.

Exclusion Criteria - Normal Group:

• Subjects unable to tolerate ophthalmic imaging;
• Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye;
• Subjects with any current ocular pathology other than cataract in either eye, as determined by self-report and confirmed by the investigator assessment and/or confirmed by the investigator assessment at the study visit;
• Subjects with (or history of) leukemia, dementia or multiple sclerosis;
• Subject has a condition or will be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Inclusion Criteria - Glaucoma Group:

• Male or female subjects from 22 years of age or older who have full legal capacity to volunteer on the date the informed consent was signed;
• Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
• Subjects who agree to participate in the study;
• Subjects who have been diagnosed with glaucoma in the glaucoma study eye(s), with optic nerve damage as evidenced by either of the following optic disc or RNFL structural abnormalities observed via fundus exam during the study visit:
• Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; or
• Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue;
• Subjects with a current BSCVA of 20/40 or better in the glaucoma study eye(s) on the date of the visit;
• History of a reliable Humphrey Field Analyzer (HFA) visual field (24-2 SITA Standard, white on white) measured on the day of study visit 1, or within the previous six (6) months from study visit 1 with reliable results, defined as fixation losses < 20%, or false positives < 33%, or false negatives < 33% in the glaucoma study eye(s) that is consistent with glaucomatous optic nerve damage in glaucoma study eye(s) based on at least one of the following findings:
• On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; or
• Glaucoma hemi-field test "outside normal limits."

Exclusion Criteria - Glaucoma Group:

• Subjects unable to tolerate ophthalmic imaging;
• Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the glaucoma study eye(s);
• Subjects with retinal disease in the glaucoma study eye(s), as determined by self-report and confirmed by the investigator assessment and/or confirmed by the investigator assessment at the study visit;
• Subjects with (or history of) leukemia, dementia or multiple sclerosis;
• Subject has a condition or will be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Inclusion Criteria - Retinal Disease Group:

• Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed