NCT06186388Completed
Glaucoma Screening
TEMPO (iMOvifa) Glaucoma Screening
Source: ClinicalTrials.gov · Last updated 26 Aug 2024
Brief summary (registry, in English)
* 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 15 Dec 2023
- Start date
- 5 Dec 2023
- Primary completion date
- 15 May 2024
- Lead sponsor
- Cape Fear Eye Institute
- Diseases
- Glaucoma
- NCT number
- NCT06186388
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 5 Dec 2023 to the primary completion date, 15 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Unable to tolerate ophthalmic imaging and/or diagnostic testing.
- Unreliable VF testing and/or poor-quality OCT scans.
- Poor fixation.
Who the study is looking for
- 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.
- IOP ≤ 21 mmHg
- Healthy anterior and posterior segment evaluation on clinical examination.
- Diagnosis of glaucoma on clinical examination.
Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cape Fear Eye Institute Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.