Visual Field Assessment for Glaucoma

Overseen By Maryann Thomas

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Gainesville Eye Associates

Disqualifiers: Macular degeneration, Retinal disease, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different devices measure vision changes in people with glaucoma, a condition that affects eyesight. The study compares three tools: the Humphrey Field Analyzer, TEMPO, and VisuALL, to determine which provides the best results. Participants will attend a one-time visit for various eye measurements and a questionnaire. Suitable candidates for this trial have good vision correction (20/30 or better) and no other eye issues, such as severe glaucoma or macular degeneration. As a Phase 4 trial, the devices are already FDA-approved and proven effective, aiming to understand how they benefit more patients.

What is the safety track record for these visual field assessment methods?

Research shows that the TEMPO visual field tester is easy for patients to use. Studies indicate that its new method of testing with both eyes makes the process faster and more comfortable, aiding in effective glaucoma testing. The TEMPO device accurately identifies the condition it tests for, ensuring safety and reliability.

Specific safety data for the VisuALL device is not available. However, its presence in Phase 4 trials indicates that it has passed earlier stages demonstrating general safety for humans. Phase 4 trials typically confirm safety and assess long-term effects, suggesting that VisuALL is also likely well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Visual Field Assessment for Glaucoma trial because it explores innovative methods to evaluate vision loss in glaucoma patients. While traditional tools like the Humphrey Field Analyzer and VisuALL are commonly used, the experimental TEMPO method stands out. TEMPO offers a potentially faster and more user-friendly way to assess visual fields, which could lead to more efficient and comfortable testing experiences for patients. By possibly increasing accuracy and reducing testing time, TEMPO could significantly enhance how glaucoma progression is monitored.

What evidence suggests that this trial's visual field assessment methods could be effective for glaucoma?

This trial will compare different visual field assessment tools for glaucoma. Research has shown that the TEMPO visual field tester, which participants may use in this trial, effectively checks for glaucoma. Most participants found it easy to use, with 73% preferring it over the Humphrey Field Analyzer (HFA), another tool tested in this trial. The TEMPO tester speeds up the process and increases comfort, aiding in accurately determining glaucoma severity. Additionally, advanced computer tools connected to TEMPO can predict the risk of glaucoma worsening, allowing for timely treatment. This suggests that TEMPO is a reliable tool for assessing glaucoma. ^{1 6 7 8 9}

Who Is on the Research Team?

Clayton Blehm, MD

Principal Investigator

North Georgia Eye Associates

Are You a Good Fit for This Trial?

This trial is for individuals with glaucoma who are able to visit the study center for an assessment. Specific eligibility details aren't provided, but typically participants would need to meet certain health criteria and be willing to undergo various tests as part of the study.

Inclusion Criteria

Adult patients with best-corrected visual outcomes of 20/30 or better.

Exclusion Criteria

Unable to tolerate ophthalmic imaging

I don't have eye conditions like severe glaucoma that could affect vision tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Participants undergo visual field assessments using the TEMPO, VisuALL, and HFA perimeters

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions or feedback post-assessment

1 week

What Are the Treatments Tested in This Trial?

Trial Overview The trial is comparing visual field assessments using three different perimeters: TEMPO, VisuALL, and HFA. It's a single-visit study where subjects will have their vision fields tested by these devices to see which gives the best results.

How Is the Trial Designed?

Group I: TEMPO Experimental Treatment 1 Intervention

Visual field assessment with the TEMPO

Group II: Humphrey Field Analyzer Active Control 1 Intervention

Visual field assessment with the Humphrey Field Analyzer

Group III: VisuALL Active Control 1 Intervention

Visual field assessment with the VisuALL

Who Is Running the Clinical Trial?

Gainesville Eye Associates

Lead Sponsor

Trials

7

Recruited

340+

Sengi

Industry Sponsor

Trials

28

Recruited

2,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10491334/

Comparison of the TEMPO Binocular Perimeter and ... 73% of participants preferred TEMPO, while 17% preferred HFA. 83% of participants reported no difficulties with TEMPO. Furthermore, TEMPO received positive ...

2. nature.com nature.com/articles/s41598-023-48105-5

Comparison of the TEMPO binocular perimeter and ... The purpose of this study was to compare the TEMPO with the Humphrey field analyzer (HFA), the most widely used automated perimeter. Results.

3. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00103-4/fulltext

Deep Learning–Based Prediction of Glaucoma Severity ... We demonstrated ISP's versatility and capability in predicting comprehensive VF information, including current severity and progression risk.

4. topconhealthcare.com topconhealthcare.com/products/tempo/

TEMPO Visual Field Tester The novel, binocular approach makes testing faster and more comfortable, which results in effective testing from screening through advanced glaucoma.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525001034

Deep Learning–Based Prediction of Glaucoma Severity ... Our DeepISP serves as an efficient tool for screening and prioritizing patients with glaucoma for clinical intervention using only a single rapid ISP test.

6. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(24)00119-2/fulltext

Reference Database for a Novel Binocular Visual Function ... Using the TEMPO/IMOvifa automated perimeter (Topcon Healthcare/CREWT Medical Systems), each subject completed 4 binocular threshold visual field ...

7. mdpi.com mdpi.com/2077-0383/14/5/1526

Validation of a Novel Suprathreshold Strategy for ... This study demonstrates that the TEMPO/IMOvifa screening program has high specificity, indicating a strong likelihood of accurate screening in an ocular-based ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3588129/

Visual field testing for glaucoma – a practical guide - PMC This article focuses on some of the more practical aspects of visual field testing, with an emphasis on assessing glaucoma.

9. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(24)00119-2/pdf

Reference Database for a Novel Binocular Visual Function ... The TEMPO/IMOvifa perimeter (Topcon Healthcare/. CREWT Medical Systems) is an automated device that conducts simultaneous VF testing of both ...