GlaucomaNCT06186388
Glaucoma Screening
A study testing TEMPO iMOvifa in people with Glaucoma, run by Cape Fear Eye Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- TEMPO iMOvifa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cape Fear Eye Institute
Wilmington, North Carolina, 28412
About this study
Official title: 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.
- Conditions
- Glaucoma
- Being tested
- TEMPO iMOvifa
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEMPO iMOvifaDiagnostic test
Screening test with 28 testing points
| Study group | Role | What they receive |
|---|---|---|
| Pathology | Other | Subjects with glaucoma-affected eyes Receives: Diagnostic Test: TEMPO iMOvifa |
| Normal | Other | Subjects with healthy eyes Receives: Diagnostic Test: TEMPO iMOvifa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
sensitivity in a population of eyes with glaucoma and specificity in a population of normal eyes
Measured: 1 day
Secondary outcomes (1)
RNFL and GCL thickness
Using Maestro2 OCT
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start5 Dec 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cape Fear Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Jones, Study director, Clinical Research Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186388
- Sponsor's protocol ID
- CF-2023-01
- Status last verified
- Aug 2024
- First submitted
- 15 Dec 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEMPO (iMOvifa) Glaucoma Screening
- ClinicalTrials.gov ID
- NCT06186388
- Acronym / sponsor ID
- CF-2023-01
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cape Fear Eye InstituteUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathology | Other | Diagnostic Test: TEMPO iMOvifaSubjects with glaucoma-affected eyes |
| Normal | Other | Diagnostic Test: TEMPO iMOvifaSubjects with healthy eyes |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEMPO iMOvifaScreening test with 28 testing points | Diagnostic test | Normal, Pathology |
Primary outcome
Sensitivity and specificity
Time frame: 1 day
sensitivity in a population of eyes with glaucoma and specificity in a population of normal eyes
1 secondary outcome
RNFL and GCL thickness
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Jones study director
Clinical Research Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEMPO iMOvifa in people with Glaucoma, run by Cape Fear Eye Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.