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Completed

NCT Number: NCT06186388

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cape Fear Eye Institute

Wilmington, North Carolina, 28412, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEMPO iMOvifa

Diagnostic Test

Screening test with 28 testing points

Primary outcomes

  1. Sensitivity and specificity

    Time frame: 1 day

    sensitivity in a population of eyes with glaucoma and specificity in a population of normal eyes

Secondary outcomes

  1. RNFL and GCL thickness

    Time frame: 1 day

    Using Maestro2 OCT

Sponsors and collaborators

Lead sponsor

Cape Fear Eye Institute

Other

Registry information

Official study title

TEMPO (iMOvifa) Glaucoma Screening

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 2, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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