Glaucoma Screening

Cape Fear Eye Institute

Status: Completed

Conditions: Glaucoma

Treatments: Diagnostic Test: TEMPO iMOvifa

Study type: Interventional

Funder types: Other

Identifiers

NCT06186388

CF-2023-01

Details and patient eligibility

About

• 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.

Enrollment: 200 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Pathology

Other group

Description:

Subjects with glaucoma-affected eyes

Treatment:

Diagnostic Test: TEMPO iMOvifa

Normal

Other group

Description:

Subjects with healthy eyes

Treatment:

Diagnostic Test: TEMPO iMOvifa