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Glaucoma Screening

Not Applicable
Completed
Conditions
Glaucoma
Interventions
Diagnostic Test: TEMPO iMOvifa
Registration Number
NCT06186388
Lead Sponsor
Cape Fear Eye Institute
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
NormalTEMPO iMOvifaSubjects with healthy eyes
PathologyTEMPO iMOvifaSubjects with glaucoma-affected eyes
Primary Outcome Measures
NameTimeMethod
Sensitivity and specificity1 day

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

Secondary Outcome Measures
NameTimeMethod
RNFL and GCL thickness1 day

Using Maestro2 OCT

Trial Locations

Locations (1)

Cape Fear Eye Institute

🇺🇸

Wilmington, North Carolina, United States

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