Performance Evaluation of Dream OCT: AP Study
This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters.
• Subjects 22 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
• BCVA 20/40 or better (each eye) on the date of the study visit
• Subjects 22 years of age or older on the date of informed consent
• Subjects 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 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 tissue
• Subjects 22 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• BCVA 20/400 or better in the study eye
• Diagnosis 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, Vein or artery Occlusions and others
• Subjects 22 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• Subjects with one of the following corneal abnormalities:
• i. Cornea disease (e.g., Fuch's or other) ii. Keratoconus iii. Cornea transplant iv. Post refractive surgery (e.g., LASIK or other) v. Dry Eye Syndrome vi. Long-term contact wearers (greater than 1 year)
• BCVA 20/400 or better in the study eye