Glaucoma Screening

TEMPO (iMOvifa) Glaucoma Screening

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06186388

Enrollment

200

Registered

2024-01-02

Start date

2023-12-05

Completion date

2024-05-15

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Brief summary

* 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.

Interventions

DIAGNOSTIC_TESTTEMPO iMOvifa

Screening test with 28 testing points

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity	1 day	sensitivity in a population of eyes with glaucoma and specificity in a population of normal eyes

Secondary

Measure	Time frame	Description
RNFL and GCL thickness	1 day	Using Maestro2 OCT

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026