Trials / Completed
CompletedNCT06186388
Glaucoma Screening
TEMPO (iMOvifa) Glaucoma Screening
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Cape Fear Eye Institute · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | TEMPO iMOvifa | Screening test with 28 testing points |
Timeline
- Start date
- 2023-12-05
- Primary completion
- 2024-05-15
- Completion
- 2024-05-15
- First posted
- 2024-01-02
- Last updated
- 2024-08-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06186388. Inclusion in this directory is not an endorsement.