Glaucoma Screening
TEMPO (iMOvifa) Glaucoma Screening
1 other identifier
interventional
200
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2023
CompletedFirst Submitted
Initial submission to the registry
December 15, 2023
CompletedFirst Posted
Study publicly available on registry
January 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2024
CompletedAugust 26, 2024
August 1, 2024
5 months
December 15, 2023
August 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity
sensitivity in a population of eyes with glaucoma and specificity in a population of normal eyes
1 day
Secondary Outcomes (1)
RNFL and GCL thickness
1 day
Study Arms (2)
Pathology
OTHERSubjects with glaucoma-affected eyes
Normal
OTHERSubjects with healthy eyes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- IOP ≤ 21 mmHg
- Healthy anterior and posterior segment evaluation on clinical examination.
- Diagnosis of glaucoma on clinical examination.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cape Fear Eye Institute
Wilmington, North Carolina, 28412, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christina Jones
Clinical Research Coordinator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2023
First Posted
January 2, 2024
Study Start
December 5, 2023
Primary Completion
May 15, 2024
Study Completion
May 15, 2024
Last Updated
August 26, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share