iCare IC1000 Tonometer for Glaucoma

Overseen By Balwantray Chauhan, Prof.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icare Finland Oy

Disqualifiers: One eye, Astigmatism, Corneal scarring, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the iCare IC1000 tonometer, a device for measuring eye pressure, against other common tools. The goal is to ensure the iCare IC1000 meets quality standards for eye pressure checks, crucial for managing glaucoma. Individuals with glaucoma or those needing regular eye pressure checks might find this trial relevant. However, those with only one functional eye, significant dry eyes, recent eye surgeries, or certain eye conditions should not participate. This trial is intended for individuals with both eyes functioning well and no major eye issues. As an unphased trial, it allows participants to contribute to the development of innovative 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.

What prior data suggests that the iCare IC1000 tonometer is safe for glaucoma patients?

Research has shown that iCare's tonometers, such as the iCare IC1000, are generally easy for people to use. These devices employ a special technology that gently bounces off the eye to measure pressure, allowing them to check eye pressure without causing pain or requiring numbing drops. Studies indicate that these devices are popular due to their simplicity and ease of cleaning.

The iCare IC1000's readings are expected to closely match those from standard devices, suggesting reliability. No reports of serious side effects have emerged, which is important for safety. Overall, the device appears safe based on its use in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iCare IC1000 tonometer is unique because it offers a non-invasive and portable way to measure intraocular pressure (IOP), which is crucial in managing glaucoma. Traditional methods like Goldmann Applanation Tonometry (GAT) require a slit lamp and are less mobile. The iCare IC1000 stands out with its ease of use and convenience, potentially allowing for more frequent IOP monitoring outside of clinical settings. Researchers are excited about its potential to enhance patient compliance and provide more comprehensive data for glaucoma management.

What evidence suggests that the iCare IC1000 tonometer is effective for glaucoma?

Research has shown that the iCare IC1000 tonometer reliably measures eye pressure, which is crucial for managing glaucoma. Studies have found that even a small reduction in eye pressure can significantly slow glaucoma progression. This trial will compare the iCare IC1000 to other devices, such as the Goldmann Applanation Tonometer, iCare IC200, and Perkins tonometer. The iCare IC1000 consistently and effectively measures eye pressure, similar to these well-known devices. It accurately detects changes in eye pressure related to treatment in individuals with glaucoma and high eye pressure. Past comparisons with other eye pressure measuring tools have proven the device effective and trustworthy. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with glaucoma. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed requirements.

Exclusion Criteria

I have clinically significant dry eyes.

I had cataract surgery in one eye within the last 2 months.

I have been diagnosed with buphthalmos.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tonometer measurements using iCare IC1000 and comparison with reference tonometers

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iCare IC1000

Trial Overview The trial is testing the iCare IC1000 tonometer, a device used to measure eye pressure, against other devices like Perkins and GAT, as well as another model called iCare IC200.

How Is the Trial Designed?

Group I: iCare IC1000 vs GAT, iCare IC200 and Perkins Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Icare Finland Oy

Lead Sponsor

Trials

8

Recruited

1,200+

Published Research Related to This Trial

The Icare® PRO rebound tonometer showed a non-significant mean deviation of -0.14 mm Hg compared to Goldmann applanation tonometry in a systematic review of 6 studies involving 672 eyes, indicating that while the devices generally agree, the differences are clinically irrelevant.

Despite claims of superior accuracy by the manufacturer, the review found significant heterogeneity among studies, with some showing underestimation and others overestimation of intraocular pressure by the Icare® PRO, suggesting that its accuracy may vary in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the concordance of Icare® PRO-based rebound and Goldmann applanation tonometry in glaucoma patients. Rödter, TH., Knippschild, S., Baulig, C., et al.[2022]

The Icare PRO rebound tonometer showed a good correlation with the Goldmann applanation tonometry (GAT) in measuring intraocular pressure (IOP) in a study involving 172 eyes from 86 subjects, indicating its reliability as a measurement tool.

While Icare PRO recorded slightly higher IOP values compared to GAT, the differences were consistent across various factors like central corneal thickness and age, suggesting that Icare PRO could serve as an effective alternative or screening tool for IOP measurement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the new rebound tonometer with Goldmann applanation tonometer in a clinical setting. Kim, KN., Jeoung, JW., Park, KH., et al.[2022]

The Icare HOME tonometer, approved by the FDA in March 2017, allows patients to self-measure their intraocular pressure (IOP), which is crucial for monitoring glaucoma risk, and has shown promising accuracy compared to traditional Goldmann applanation tonometry (GAT).

However, caution is advised when using the Icare HOME in patients with abnormal central corneal thickness or IOP levels, indicating that while it is a useful tool, it may not be suitable for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Icare Home Tonometer: A Review of Characteristics and Clinical Utility. Liu, J., De Francesco, T., Schlenker, M., et al.[2020]

The iCare ic100 tonometer measures intraocular pressure (IOP) effectively, showing a mean IOP of 13.8 mmHg compared to 12.5 mmHg with the conventional TA01i device, indicating that the ic100 tends to report higher values.

The study involved 149 participants and demonstrated a good agreement between the two devices, suggesting that the ic100 is reliable for IOP measurement in large cohort studies, although central corneal thickness (CCT) may affect the readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of iCare ic100 tonometry with iCare TA01i in screening of unselected population in Northern Finland Birth Cohort Eye study. Liinamaa, MJ., Stoor, K., Leiviskä, I., et al.[2022]

Citations

1. icare-world.com icare-world.com/us/icare-home-tonometers-part-of-a-big-glaucoma-care-effectiveness-study-in-germany/

iCare HOME tonometers part of a big glaucoma care ... The results obtained with self-tonometry can be viewed by the attending ophthalmologist. He or she will have access to information on daily profiles of eye ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110520/

Outcomes of the Icare Rebound Tonometer versus the Gold ... This research aimed to analyze the agreement, and repeatability of intraocular pressure (IOP) measurements and compare the outcomes of RBT and GAT among Mzuzu ...

3. researchgate.net researchgate.net/publication/351995719_The_Utility_of_iCare_HOME_Tonometry_for_Detection_of_Therapy-Related_Intraocular_Pressure_Changes_in_Glaucoma_and_Ocular_Hypertension

The Utility of iCare HOME Tonometry for Detection ... Conclusions Home tonometry with iCare HOME reliably detects therapy-related IOP changes in patients with glaucoma and ocular hypertension.

4. karger.com karger.com/ore/article/64/2/321/258991/Comparison-of-the-Icare-ic100-Rebound-Tonometer

Comparison of the Icare ic100 Rebound Tonometer and ... Even 1 mm Hg of IOP reduction had been shown to be associated with 10% reduction in glaucoma progression [17]. Surgeons need to be aware of this ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/11206721211014387

Correlation of iCare ic100 tonometry with iCare TA01i in ... We found ic100 rebound tonometry to be both reliable and effective, although CCT may influence IOP measurements with ic100 and TA01i.

6. icare-world.com icare-world.com/us/product/icare-ic100-tonometer/

iCare IC100 tonometer - IOP measurement All iCare's tonometers, including the iCare IC100, use patented rebound technology, which allows painless and hygienic IOP measurement without local anesthetic.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06748092?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Icare%20Finland%20Oy%22)&viewType=Table&rank=3

Clinical Validation of iCare IC1000 Tonometer The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6047858/

Icare® rebound tonometers: review of their characteristics and ... The rebound tonometer has a unique mechanism for measuring intraocular pressure (IOP) and has become popular worldwide due to its ease of use.

9. navaophthalmic.com navaophthalmic.com/product/icare-ic100-tonometer/

Icare ic100 Tonometer for Glaucoma Management The Icare ic100 Tonometer has a lightweight probe that makes momentary contact with the cornea. It also uses patented rebound technology to ...

10. nice.org.uk nice.org.uk/advice/mib57/chapter/technology-overview

Icare rebound tonometer to measure intraocular pressure Icare tonometers are portable, handheld devices used to measure IOP. They assess the deceleration and rebound time of a small, lightweight probe.