Glaucoma Screening

TEMPO (iMOvifa) Glaucoma Screening

• The primary objective of this study is to evaluate the diagnostic accuracy of the TEMPO (iMOvifa) visual field perimeter screening test by measuring the sensitivity in a population of eyes with glaucoma and the specificity in a population of normal eyes and to measure repeatability of the screening test.
• The secondary objective of this study is to gather and analyze ancillary data to confirm the diagnosis or absence of glaucoma.

Inclusion Criteria (All subjects):

• Subjects 40 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 both eyes.

Inclusion Criteria- Normal Population

• IOP ≤ 21 mmHg
• Healthy anterior and posterior segment evaluation on clinical examination.

Inclusion Criteria - Pathology Population

• Diagnosis of glaucoma on clinical examination.

Exclusion Criteria (All subjects):

• Unable to tolerate ophthalmic imaging and/or diagnostic testing.
• History of intraocular surgery (uncomplicated surgeries are accepted).
• Ocular diseases including uveitis, non-glaucomatous optic neuropathy, severe or proliferative diabetic/ hypertensive retinopathy (controlled diabetes and hypertension participants with no or mild to moderate retinopathy [not involving the macula] can be included), unresolved trauma.
• Any neurodegenerative diseases including Alzheimer, Parkinson, or dementia, or history of stroke.
• Unreliable VF testing and/or poor-quality OCT scans.
• Poor fixation.