Overview

Images captured on the P200TE device on glaucoma patients

Eligibility

Inclusion Criteria

Subjects were 22 years of age or older on the date of informed consent;

        Subjects were able to understand the written informed consent and willing to participate as
        evidenced by signing the informed consent;
        BCVA 20/40 or better in the study eye;
        History of visual field defects within the previous year from the study visit or measured
        the day of the study visit consistent with glaucomatous optic nerve damage with at least
        one of the following two findings:
        On pattern deviation (PD), there existed 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;"
        Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal
        nerve fiber layer structural abnormalities:
        Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the
        inferior or superior poles with or without disc hemorrhage; and
        Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
        Exclusion Criteria
        Subjects unable to tolerate ophthalmic imaging;
        Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the
        study eye;
        Subject has a condition or is 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;
        No reliable visual field test result within the past year of the study visit, defined as
        fixation losses > 33% or false positives >33%, or false negatives >33% in the study eye;
        Presence of any ocular pathology except glaucoma in the study eye.