P200TE and Predicate Agreement and Precision Study

This study is a prospective comparative, randomized, single center study to assess agreement and precision of the P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.

Inclusion Criteria for Normal GroupSubjects 22 years of age or older on the date of informed consentSubjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consentSubjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lensBCVA 20/40 or better (each eye) on the date of the study visitExclusion Criteria for Normal GroupSubjects unable to tolerate ophthalmic imagingSubjects not able to obtain acceptable OCT images due to ocular media opacity or other reasonsSubject 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 studyPresence of any ocular pathology except for cataract in either eyeInclusion Criteria for Glaucoma GroupSubjects 22 years of age or older on the date of informed consentSubjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consentBCVA 20/40 or better in the study eyeHistory 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 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;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;Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissueExclusion Criteria for Glaucoma GroupSubjects unable to tolerate ophthalmic imagingSubjects not able to obtain acceptable OCT images due to ocular media opacity or other reasonsSubject 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 studyNo reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard or Fast, white on white) 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 eyePresence of any ocular pathology except glaucoma in the study eyeInclusion Criteria for Retina Disease GroupSubjects 22 years of age or older on the date of informed consentSubjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consentSubjects presenting at the site with retinal diseaseBCVA 20/400 or better in the study eyeDiagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including patients with drusen and geographic atrophy and choroidal neovascularization), Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy and othersExclusion Criteria for Retinal Disease GroupSubjects unable to tolerate ophthalmic imagingSubjects not able to obtain acceptable OCT images due to ocular media opacity or other reasonsSubject 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 studyPresence of glaucoma or any ocular pathology other than a retinal pathology (e.g., cornea pathology) in the study eye as determined by self report and/or investigator assessment at the study visit;