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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well the Tono-Vera tonometer measures eye pressure compared to other tools. Eye pressure is crucial for individuals with glaucoma, a condition that can damage vision. The trial aims to determine if this new device provides accurate readings. Prospective participants should be in good health and able to attend the study appointment. Individuals with certain eye conditions, such as difficulty keeping their eyelids open, may not qualify. As an unphased trial, this study allows patients to contribute to the advancement of eye care technology.

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 prior data suggests that the Tono-Vera tonometer is safe for measuring intraocular pressure?

Research shows that the Tono-Vera tonometer is safe for checking eye pressure. Studies confirm it provides consistent and reliable results. Importantly, experts recognize the device as safe and effective for measuring intraocular pressure. When used correctly, it is generally well-tolerated and does not cause harm. Available data report no problems related to its use. This should reassure those considering joining the study about the device's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard methods for measuring intraocular pressure (IOP) in glaucoma patients, the Tono-Vera tonometer offers a potentially more accurate and reliable way to assess eye pressure. Current devices often require skilled operators and can be uncomfortable for patients. Tono-Vera stands out for its user-friendly design, which could allow for easier and less invasive measurements. Researchers are excited because this device might lead to better monitoring and management of glaucoma, ultimately helping to prevent vision loss.

What evidence suggests that the Tono-Vera tonometer is effective for measuring intraocular pressure in glaucoma?

Research has shown that the Tono-Vera device, used by participants in this trial, accurately measures eye pressure, crucial for managing glaucoma. One study found that Tono-Vera's accuracy matches that of the Goldmann tonometer, a trusted tool in eye care. Another study demonstrated that Tono-Vera's readings are very close, with an average difference of only 1.16 mmHg. These findings suggest that Tono-Vera reliably checks eye pressure, aiding in the effective monitoring and treatment of glaucoma. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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

Patients in good general health as evidenced by ability to come to their appointment on day of study

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11362087/

Evaluation of agreement of IOP measurements by Tono-Vera ... Tono-Vera meets the requirements of ANSI Z80. 10-2014 and ISO 8612-2009, demonstrating accuracy comparable to Goldmann tonometry.

2. withpower.com withpower.com/trial/phase-glaucoma-7-2022-ecfad

TonoVera Device Accuracy for Glaucoma The research suggests that various tonometers, including those similar to the Tono-Vera, are effective in measuring intraocular pressure (IOP), which is crucial ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05523622

Comparison of Intraocular Pressure Measurement With the ... Study Overview. We are testing the accuracy of Reichert's Tono-Vera tonometer by comparing measurements of IOP with this device and measurements with other ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12147360/

Comparison of measurement performance among Tono-Vera ... TVV demonstrated superior accuracy in the physiological range, with a mean deviation of 1.16 ± 2.31 mmHg and narrow limits of agreement (min =− ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/vop.13213

Validation of the Reichert® Tono‐Vera® Vet rebound ... In conclusion, the Reichert Tono-Vera® Vet tonometer provides accurate IOP readings in dogs with applying the automated positioning system.

6. reichert.com reichert.com/en/products/tono-vera

Tono-Vera ® Tonometer Tono-Vera provides more objective and repeatable results giving you confidence in your intraocular pressure (IOP) readings. For nearly two centuries, Reichert ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233516.pdf

Tono-Vera® Tonometer and Ocu-Dot ... - accessdata.fda.gov The results demonstrate that Reichert Tono-Vera® Tonometer is safe and effective at IOP tonometry measurements without the need for ...

8. danscottandassociates.com danscottandassociates.com/wp-content/uploads/2024/01/tono-vera_vet_manual.pdf

Tono-Vera™ Vet NOTE: Tono-Vera Vet Tonometer is not approved for use on humans. This Instructions for Use guide is designed as a training and reference manual for operation, ...