Glaucoma Screening

August 22, 2024 updated by: Cape Fear Eye Institute

TEMPO (iMOvifa) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28412
        • Cape Fear Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pathology
Subjects with glaucoma-affected eyes
Diagnostic test: TEMPO iMOvifa
Screening test with 28 testing points
Other: Normal
Subjects with healthy eyes
Diagnostic test: TEMPO iMOvifa
Screening test with 28 testing points

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity
Time Frame: 1 day
sensitivity in a population of eyes with glaucoma and specificity in a population of normal eyes
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RNFL and GCL thickness
Time Frame: 1 day
Using Maestro2 OCT
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cape Fear Eye Institute

Investigators

  • Study Director: Christina Jones, Clinical Research Coordinator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

January 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF-2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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