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

250 Participants Needed

Trial Summary

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 data supports the effectiveness of the iCare IC1000 treatment for glaucoma?

The iCare IC1000 tonometer is a device used to measure eye pressure, which is important for managing glaucoma. Studies show that similar iCare tonometers, like the Icare PRO and Icare HOME, provide accurate measurements compared to the traditional Goldmann applanation tonometer, suggesting that the iCare IC1000 could also be effective for monitoring glaucoma. ^{1 2 3 4 5}

Is the iCare IC1000 Tonometer safe for use in humans?

The iCare tonometers, including models like the IC1000, are generally considered safe for measuring eye pressure in humans. They are portable and easy to use, and studies have shown them to be accurate and reliable when compared to other standard devices. ^{1 2 4 6 7}

How does the iCare IC1000 treatment for glaucoma differ from other treatments?

The iCare IC1000 is a unique treatment for glaucoma as it is a portable device that measures intraocular pressure (IOP) using a rebound method, which involves a light probe making brief contact with the eye. This method is patient-friendly, does not require anesthesia, and can be used in various positions, making it more versatile compared to traditional tonometers like the Goldmann applanation tonometer. ^{2 3 5 6 7}

What is the purpose of this trial?

Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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® 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]

References

1. India pubmed.ncbi.nlm.nih.gov

Agreement and repeatability of Icare ic100 tonometer. [2022]

2. United States 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. [2022]

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

Comparison of the new rebound tonometer with Goldmann applanation tonometer in a clinical setting. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Icare Home Tonometer: A Review of Characteristics and Clinical Utility. [2020]

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

Meta-analysis of the concordance of Icare® PRO-based rebound and Goldmann applanation tonometry in glaucoma patients. [2022]

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

Rebound tonometry by iCare 200 (IC200): comparison with Tono-Pen in the operating room and Goldmann applanation in the clinic. [2022]

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

Accuracy of the new ICare rebound tonometer vs. other portable tonometers in healthy eyes. [2022]