GlaucomaPhase 4NCT06539715
Comparison of Visual Field Assessments Between Three Perimeters
A Phase 4 study testing Visual field assessment in people with Glaucoma, run by Gainesville Eye Associates at 1 site in United States.
Trial summary
A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Visual field assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 12 Mar 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with best-corrected visual outcomes of 20/30 or better.
Who cannot join
- Unable to tolerate ophthalmic imaging
- Any ocular or systemic conditions, that could affect VF test results, such as age-related macular degeneration, peripheral retinal disease, or severe glaucoma.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Georgia Eye Associates
Gainesville, Georgia, 30501
About this study
A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire.
- Conditions
- Glaucoma
- Being tested
- Visual field assessment
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual field assessmentDiagnostic test
Automated perimetry
| Study group | Role | What they receive |
|---|---|---|
| TEMPO | Experimental | Visual field assessment with the TEMPO Receives: Diagnostic Test: Visual field assessment |
| Humphrey Field Analyzer | Active comparator | Visual field assessment with the Humphrey Field Analyzer Receives: Diagnostic Test: Visual field assessment |
| VisuALL | Active comparator | Visual field assessment with the VisuALL Receives: Diagnostic Test: Visual field assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Acquisition Time (Both Eyes)
The total time to complete automated perimetry in both eyes.
Measured: Visit 1 (Day 0)
Secondary outcomes (4)
Mean Deviation (MD)
visual field mean deviation (unit = decibels)
Measured: Visit 1 (Day 0)
Pattern Standard Deviation (PSD)
visual field pattern standard deviation (unit = decibels) PSD is a measure of visual field irregularity.
Measured: Visit 1 (Day 0)
Foveal Threshold (FT)
visual field foveal threshold (unit = decibels)
Measured: Visit 1 (Day 0)
Patient Questionnaire
A series of 9 Likert style questions (Strongly Disagree to Strongly Agree) that patients answered about the comfort, ease of use, and anxiety with each device. Strongly Agree was considered a better outcome for comfort and ease of use questions, and Strongly Disagree was considered a better outcome for anxiety questions.
Measured: Visit 1 (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start18 Nov 2024
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gainesville Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Clayton Blehm, MD, Principal investigator, North Georgia Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539715
- Sponsor's protocol ID
- CB-24-01
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2024
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Field Assessments Between Three Perimeters
- ClinicalTrials.gov ID
- NCT06539715
- Acronym / sponsor ID
- CB-24-01
- Conditions
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Gainesville Eye AssociatesUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Posted 30 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TEMPO | Experimental | Diagnostic Test: Visual field assessmentVisual field assessment with the TEMPO |
| Humphrey Field Analyzer | Active comparator | Diagnostic Test: Visual field assessmentVisual field assessment with the Humphrey Field Analyzer |
| VisuALL | Active comparator | Diagnostic Test: Visual field assessmentVisual field assessment with the VisuALL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with best-corrected visual outcomes of 20/30 or better.
Key exclusion criteria (3 listed)
- Unable to tolerate ophthalmic imaging
- Any ocular or systemic conditions, that could affect VF test results, such as age-related macular degeneration, peripheral retinal disease, or severe glaucoma.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
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 |
|---|---|---|
| Visual field assessmentAutomated perimetry | Diagnostic test | Humphrey Field Analyzer, TEMPO, VisuALL |
Primary outcome
Total Acquisition Time (Both Eyes)
Time frame: Visit 1 (Day 0)
The total time to complete automated perimetry in both eyes.
4 secondary outcomes
Mean Deviation (MD)
Time frame: Visit 1 (Day 0)
Pattern Standard Deviation (PSD)
Time frame: Visit 1 (Day 0)
Foveal Threshold (FT)
Time frame: Visit 1 (Day 0)
Patient Questionnaire
Time frame: Visit 1 (Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Clayton Blehm, MD principal investigator
North Georgia Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Visual field assessment in people with Glaucoma, run by Gainesville Eye Associates 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 1 inclusion and 3 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 30 Apr 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Acquisition Time (Both Eyes) (time frame: Visit 1 (Day 0)). 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 30 Apr 2026.