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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether people with mild to moderate open-angle glaucoma can use new technology to monitor their condition at home. Participants will test devices, including the iCare Home Tonometer (for measuring eye pressure) and the visuALL H (a portable perimeter for home visual field testing), to determine if home monitoring matches the effectiveness of doctor visits. The study seeks participants diagnosed with mild to moderate open-angle glaucoma who have good vision in at least one eye. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve home-based glaucoma care.

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 prior data suggests that these home testing devices for glaucoma are safe?

Studies have shown that the iCare Home Tonometer reliably and safely checks eye pressure at home. It effectively measures eye pressure, crucial for managing glaucoma. The device is easy to use and performs as well as methods in doctor's offices.

Research indicates that Spectralis Optical Coherence Tomography (OCT) safely and effectively monitors changes in the eye. It helps detect glaucoma by providing clear images of the eye's structure, which doctors use to track the disease.

Standard Automatic Perimetry, such as the Humphrey Field Analyzer, is a well-established and safe tool for checking vision. It aids in diagnosing and monitoring vision changes in glaucoma patients.

Lastly, the VisuALL H, a virtual reality device for testing vision, shows promise as a safe home testing option. Although specific safety data for this device is limited, it is generally considered a safe alternative to traditional methods.

Overall, these tools are well-tolerated and have been shown to be safe for use at home and in clinics. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these at-home testing devices for glaucoma because they empower patients to monitor their condition more frequently and conveniently. Unlike traditional in-office tests that happen only every few months, the iCare Home Tonometer allows patients to measure their eye pressure three times a day, offering a more detailed picture of their eye health over time. Additionally, the Olleyes Perimeter enables patients to self-assess their visual field weekly, providing ongoing updates between routine appointments. This increased frequency and accessibility could lead to earlier detection of changes in the condition, potentially improving outcomes for those with glaucoma.

What evidence suggests that these home testing devices are effective for glaucoma?

Research has shown that the iCare Home Tonometer, which participants in this trial will use, effectively checks eye pressure in people with glaucoma. One study detected treatment responses in 90.9% of cases, proving its suitability for home use. Patients found it easy and comfortable to use, and most were willing to use it again.

Spectralis Optical Coherence Tomography (OCT), another device used in this trial, helps detect glaucoma progression early. Some studies suggest it can identify changes one to two years before other methods. It is precise and reliable for measuring eye structures.

Standard Automated Perimetry, like the Humphrey Field Analyzer, is essential for checking vision loss and is part of the routine assessments in this trial. It remains a key method for assessing changes in the visual field in glaucoma.

VisuALL H, a virtual reality vision testing system included in this trial, allows patients to perform vision tests at home. Studies show its results are similar to standard tests, proving its reliability for regular monitoring. ^{3 6 7 8 9}

Who Is on the Research Team?

M. Reza Razeghinejad, MD

Principal Investigator

Wills Eye Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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