Home Testing Devices for Glaucoma

Overseen By Dilru Amarasekera, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wills Eye

Must not be taking: Visual function drugs

Disqualifiers: Severe vision loss, Recent surgeries, others

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

Compensation: Varies

Number of Visits: 6

50 Participants Needed

Trial Summary

What is the purpose of this trial?

With the advancement in technology we have the opportunity of performing the glaucoma testing at home to monitor the disease. The purpose of this study is evaluating the feasibility and patient acceptance of home testing with head mounted perimetry; detection of progression with head mounted perimetry vs office based perimetry; and monitoring the eye pressure measured by patients at home using a portable tonometer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications known to affect visual function or reaction time.

What data supports the effectiveness of the treatment iCare Home Tonometer for glaucoma?

Research shows that the iCare HOME tonometer is effective for glaucoma patients to measure their own eye pressure (intraocular pressure or IOP) accurately and reliably, which is important for managing the condition. It allows patients to track their IOP at home, providing a more complete picture of daily fluctuations compared to single office measurements. ^{1 2 3 4 5}

Is the iCare Home Tonometer safe for use in humans?

The iCare Home Tonometer is generally considered safe for self-monitoring of eye pressure in glaucoma patients, as it has been approved by the US Food and Drug Administration. However, caution is advised for patients with certain eye conditions, such as unusual corneal thickness or pressure ranges. ^{1 2 3 5 6}

How does the Icare HOME tonometer treatment for glaucoma differ from other treatments?

The Icare HOME tonometer is unique because it allows glaucoma patients to measure their own eye pressure at home, providing a more complete picture of daily fluctuations compared to traditional office-based methods. This self-monitoring approach can help in better managing the condition by capturing variations that might be missed during single office visits. ^{1 2 3 5 6}

Research Team

M. Reza Razeghinejad, MD

Principal Investigator

Wills Eye Hospital

Eligibility Criteria

This trial is for people aged 20-80 with mild to moderate Open-Angle Glaucoma and a refraction under ±12.00 diopters of spherical error and astigmatism under 2.5 diopters. It's not for those with visual acuity worse than 20/50, recent eye surgery, inability to use the devices after training, conditions or medications affecting vision, or unwillingness to participate.

Inclusion Criteria

Refraction under 12.00 diopter of spherical refractive error and astigmatism of less than 2.5 diopter.

I am between 20 and 80 years old.

I have been diagnosed with mild or moderate open angle glaucoma.

Exclusion Criteria

Spherical refraction outside > ± 12.00 D and cylinder correction > +2.5 D

I am willing and able to participate in the study.

I have a condition affecting my vision, not including glaucoma or mild/moderate cataracts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Routine glaucoma assessment with standard 24-2 Automatic Perimetry Humphrey Field Analyzer and Spectralis Optical Coherence Tomography

Initial visit

1 visit (in-person)

Home Monitoring

Participants use Olleyes Perimeter for visual field testing weekly and iCare Home Tonometer for eye pressure measurement 3 times a day for 7 days every 3 months

2 years

Weekly home testing

In-office Follow-up

Participants undergo in-office visual field testing with Humphrey Field Analyzer every 6 months and RNFL thickness measurement yearly

2 years

5 visits (in-person) for visual field, 3 visits (in-person) for RNFL

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• iCare Home Tonometer
• Spectralis Optical coherence tomography (OCT)
• Standard Automatic Perimetry Humphrey Field Analyzer
• visuALL H

Trial Overview The study tests if glaucoma patients can effectively monitor their condition at home using head-mounted perimetry (visuALL H) and a portable tonometer (iCare Home Tonometer), compared to traditional office-based methods like OCT scans and Humphrey Field Analyzer.

Participant Groups

Group I: Moderate Glaucoma Experimental Treatment 4 Interventions

Subjects between ages 20-80 years with a diagnosis of mild and moderate Open Angle Glaucoma in at least one eye with 20/50 vision or better will be included in this study. All subjects will have the Olleyes Perimeter measure their own visual acuity and field once a week during a 2 year period and iCare home to measure their eye pressure 3 times a day for 7 days every 3 months during a 2 year period. All patient will have their routine glaucoma assessment with the standard 24-2 Automatic Perimetry Humphrey Field Analyzer at baseline and every 6 months during a 2 year period; and Spectralis Optical Coherence Tomography thickness of peripapillary RNFL and macular ganglion cell at baseline and yearly during a 2 year period.

Who Is Running the Clinical Trial?

Wills Eye

Lead Sponsor

Trials

81

Recruited

15,400+

Findings from Research

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® Home tonometer is a reliable and reproducible device for measuring intraocular pressure (IOP) in glaucoma patients, with 85% of participants successfully using it for self-monitoring.

While the Icare® Home tonometer provides consistent measurements, it tends to slightly underestimate IOP compared to the Goldmann applanation tonometer, indicating it may be a useful but not perfectly equivalent alternative for monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reliability and reproducibility of introcular pressure (IOP) measurement with the Icare® Home rebound tonometer (model TA022) and comparison with Goldmann applanation tonometer in glaucoma patients]. Valero, B., Fénolland, JR., Rosenberg, R., et al.[2019]

In a study involving 12 glaucoma patients, 83% successfully measured their intraocular pressure (IOP) at home after receiving remote training via video link, demonstrating the feasibility of remote self-tonometry.

All participants expressed satisfaction with the remote training method and showed interest in continuing home IOP monitoring, indicating that video calls can be an effective platform for patient education in managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching home tonometry using a remote video link. Barbour-Hastie, CC., Tatham, AJ.[2023]

The iCare HOME tonometer allows trained glaucoma patients to accurately self-measure their intraocular pressure (IOP), with 80% of patients achieving readings within 3 mm Hg of professional measurements before training, improving to 90% after one week of self-monitoring.

The device demonstrated good inter-rater reliability, meaning that patients' measurements were consistent with those taken by healthcare professionals, and 89% of patients found it easy to use and would recommend it to others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and Reliability of Self-measured Intraocular Pressure in Glaucoma Patients Using the iCare HOME Tonometer. Ogle, JJ., Soo Hoo, WC., Chua, CH., et al.[2023]

The Icare HOME device is safe and reliable for self-tonometry in glaucoma patients, with 91.3% of participants obtaining intraocular pressure (IOP) measurements within 5 mmHg of the standard Goldmann applanation tonometry (GAT).

However, about 16% of participants were unable to certify their use of the device due to difficulties in obtaining accurate measurements, indicating that while the device is effective for many, not all patients may be able to use it successfully.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Icare HOME (TA022) Study: Performance of an Intraocular Pressure Measuring Device for Self-Tonometry by Glaucoma Patients. Mudie, LI., LaBarre, S., Varadaraj, V., et al.[2019]

The iCare HOME tonometer (HT) and Virtual Field (VF) devices were found to be highly acceptable and feasible for home monitoring of glaucoma, with 73.7% of patients finding the HT easy to use and 100% finding it useful, while all patients reported the VF as easy to use and 94.4% found it useful.

All patients successfully completed the required tests at home, indicating that home monitoring can empower patients by providing them with more control over their eye health and potentially improving glaucoma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Monitoring of Glaucoma Using a Home Tonometer and a Novel Virtual Reality Visual Field Device: Acceptability and Feasibility. Hu, GY., Prasad, J., Chen, DK., et al.[2023]

References

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

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

2. France pubmed.ncbi.nlm.nih.gov

[Reliability and reproducibility of introcular pressure (IOP) measurement with the Icare® Home rebound tonometer (model TA022) and comparison with Goldmann applanation tonometer in glaucoma patients]. [2019]

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

Teaching home tonometry using a remote video link. [2023]

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

Accuracy and Reliability of Self-measured Intraocular Pressure in Glaucoma Patients Using the iCare HOME Tonometer. [2023]

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

The Icare HOME (TA022) Study: Performance of an Intraocular Pressure Measuring Device for Self-Tonometry by Glaucoma Patients. [2019]

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

Home Monitoring of Glaucoma Using a Home Tonometer and a Novel Virtual Reality Visual Field Device: Acceptability and Feasibility. [2023]