Glaucoma Screening

Glaucoma Clinical Trial

Official title:

TEMPO (iMOvifa) Glaucoma Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186388
• Other study ID #: CF-2023-01
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: Cape Fear Eye Institute
• Contact: James Fanelli, OD
• Phone: 910-452-7225
• Email: faneleye[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Diagnostic Test:
• TEMPO iMOvifa
Screening test with 28 testing points

Locations

Country	Name	City	State
United States	Cape Fear Eye Institute	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cape Fear Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity	sensitivity in a population of eyes with glaucoma and specificity in a population of normal eyes	1 day
Secondary	RNFL and GCL thickness	Using Maestro2 OCT	1 day