Status:
COMPLETED
Glaucoma Screening
Lead Sponsor:
Cape Fear Eye Institute
Conditions:
Glaucoma
Eligibility:
All Genders
40+ years
Phase:
NA
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 glau...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06186388
Start Date
December 5 2023
End Date
May 15 2024
Last Update
August 26 2024
Active Locations (1)
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1
Cape Fear Eye Institute
Wilmington, North Carolina, United States, 28412