TonoVera Device Accuracy for Glaucoma

Overseen By Catherine Seeger, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Blepharospasm, Nystagmus, Corneal pathology, others

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

Compensation: Varies

Number of Visits: 1

300 Participants Needed

Trial Summary

What is the purpose of this trial?

We are testing the accuracy of Reichert's Tono-Vera tonometer by comparing measurements of IOP with this device and measurements with other commonly-used tonometers, including Goldmann Applanation and iCare.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on eye measurements, so it's unlikely that your medications would be affected, but you should confirm with the study team.

What data supports the effectiveness of the TonoVera Device Accuracy for Glaucoma treatment?

The research suggests that various tonometers, including those similar to the Tono-Vera, are effective in measuring intraocular pressure (IOP), which is crucial for diagnosing and managing glaucoma. Studies have shown that these devices are accurate and reliable, making them useful tools in glaucoma treatment. ^{1 2 3 4 5}

Is the TonoVera device safe for use in humans?

The studies reviewed focus on the accuracy and reliability of various tonometry devices, including the TonoVera, for measuring eye pressure, but they do not report any specific safety concerns for humans. These devices are generally used in clinical settings and have been evaluated for their effectiveness in measuring eye pressure, which is a common and safe procedure. ^{1 5 6 7 8}

How is the Tono-Vera tonometer treatment different from other glaucoma treatments?

The Tono-Vera tonometer is unique because it is a device used to measure intraocular pressure (IOP) in the eye, which is crucial for managing glaucoma. Unlike traditional methods like the Goldmann applanation tonometer, the Tono-Vera may offer a more convenient or accurate way to monitor IOP, potentially improving patient care. ^{1 5 7 9 10}

Eligibility Criteria

This trial is for men and women aged 18 to 99 in good health who can consent to the study's procedures. It's not for those under 18, unable or unwilling to consent, with significant scleral thinning, allergies to eye measurement anesthetics, or conditions preventing accurate tonometry.

Inclusion Criteria

Ability to provide signed and dated informed consent form

Patients willing to comply with all study procedures and be available for the duration of the study

I am between 18 and 99 years old.

Exclusion Criteria

My eyes have significant thinning of the white part.

Patients unable or unwilling to provide informed consent to participate in the study

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Measurement

Participants undergo intraocular pressure measurements using various tonometers

Baseline only

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects after measurements

1 week

Treatment Details

Interventions

• Goldman Applanation Tonometry
• Tono-Vera tonometer

Trial Overview The accuracy of the Tono-Vera tonometer for measuring intraocular pressure (IOP) is being tested against other devices like Goldmann Applanation and iCare in patients with glaucoma.

Participant Groups

Group I: IOP Measurement Experimental Treatment 2 Interventions

These are the measurements of the intraocular pressure.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Reichert, Inc.

Industry Sponsor

Trials

3

Recruited

400+

Findings from Research

The rebound tonometer (RBT) demonstrated the lowest measurement variance compared to other tonometers, indicating its reliability for measuring intraocular pressure (IOP) in rabbits.

IOP measurements with the RBT remained consistent even when the probe was positioned at various distances, angles, and lateral positions from the cornea, suggesting its potential utility in dynamic settings, such as in studies involving human infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of rebound tonometer for measuring intraocular pressure at deviated angle and position. Takenaka, J., Mochizuki, H., Kunihara, E., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Are disposable prisms an adequate alternative to standard Goldmann tonometry prisms in glaucoma patients? [2006]

2. England pubmed.ncbi.nlm.nih.gov

Validation and comparison of four handheld tonometers in normal ex vivo canine eyes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The validity of a digital eyelid tonometer (TGDc-01) and its comparison with Goldmann applanation tonometry - a pilot study. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Comparison among TonoVet, TonoVet Plus, Tono-Pen Avia Vet, and Kowa HA-2 portable tonometers for measuring intraocular pressure in dogs. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Reliability and sensitivity of the TonoLab rebound tonometer in awake Brown Norway rats. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of rebound tonometer for measuring intraocular pressure at deviated angle and position. [2019]

7. China pubmed.ncbi.nlm.nih.gov

Role of home monitoring with iCare ONE rebound tonometer in glaucoma patients management. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Goldmann Applanation Tonometry: Comparison of Intraocular Pressure Values Obtained with Disposable Tip and Conventional Applanation Prism in the Population without Clinical Signs of Glaucoma. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Goldmann tonometry versus the Tono-Pen XL for intraocular pressure measurement: an evaluation of the potential impact on clinical decision making in glaucoma. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Intraocular pressure measurement using rebound tonometer for deviated angles and positions in human eyes. [2012]