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Glaucoma Screening

NCT06186388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-26

No results posted yet for this study

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

DIAGNOSTIC_TEST

TEMPO iMOvifa

Screening test with 28 testing points

Sponsors & Collaborators

  • Cape Fear Eye Institute

    lead OTHER

Principal Investigators

  • Christina Jones · Clinical Research Coordinator

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2024-05-15
Completion
2024-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186388 on ClinicalTrials.gov