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Diagnostic Test

Pathology for Glaucoma

N/A

Recruiting

Research Sponsored by Cape Fear Eye Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects 40 years of age or older on the date of informed consent

Diagnosis of glaucoma on clinical examination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Study Summary

This trial aims to test the accuracy of a visual field screening test for glaucoma. It will measure how well the test can detect the disease in people with glaucoma and how well it can

Who is the study for?

This trial is for people over 40 who can legally consent and have good vision (20/40 or better) in both eyes, normal eye pressure, healthy eyes upon examination, and a clinical diagnosis of glaucoma. It's not for those with certain eye surgeries, other serious eye diseases, neurodegenerative conditions like Alzheimer's or Parkinson's disease, history of stroke, or if they can't undergo eye imaging/tests.Check my eligibility

What is being tested?

The study is testing the TEMPO iMOvifa visual field perimeter screening test to see how well it identifies glaucoma by comparing its sensitivity in detecting glaucoma against its ability to correctly identify when it’s not present. The repeatability of this screening will also be assessed.See study design

What are the potential side effects?

Since the intervention involves a non-invasive diagnostic test rather than medication or surgery, there are no direct side effects associated with TEMPO iMOvifa. However, discomfort from bright lights or fatigue from testing may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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I have been diagnosed with glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity and specificity

Secondary outcome measures

RNFL and GCL thickness

Trial Design

2Treatment groups

Experimental Treatment

Group I: PathologyExperimental Treatment1 Intervention

Subjects with glaucoma-affected eyes

Group II: NormalExperimental Treatment1 Intervention

Subjects with healthy eyes

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cape Fear Eye InstituteLead Sponsor

Christina JonesStudy DirectorClinical Research Coordinator

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available slots for patients to participate in this ongoing clinical trial?

"According to the latest information available on clinicaltrials.gov, this trial is currently seeking participants. The initial posting of the trial was made on December 5th, 2023 and it was last edited on December 15th, 2023."

Answered by AI

How many individuals in total are involved as participants in this research investigation?

"Indeed, the information available on clinicaltrials.gov verifies that this investigation is currently seeking eligible individuals. The trial was initially posted on December 5th, 2023 and recently updated on December 15th, 2023. This particular study aims to recruit a total of 200 participants from a single location."

Answered by AI