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Home Testing Devices for Glaucoma

N/A

Recruiting

Led By M. Reza Razeghinejad, MD

Research Sponsored by Wills Eye

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 20-80 years

Mild and Moderate Open Angle Glaucoma (OAG)

Must not have

Inability to use device after remote training session

History of systemic or ocular condition (other than glaucoma or mild to moderate cataract) known to affect visual function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 minutes each week for 104 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to do glaucoma testing at home, to see if it's feasible and if patients like it. They will also compare it to the current way of testing in the office, and monitor eye pressure at home.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive monitoring equipment rather than medication, side effects are minimal but may include discomfort from wearing the head-mounted device or difficulty in self-measuring eye pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 20 and 80 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can't use the device even after being trained remotely.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 minutes each week for 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 minutes each week for 104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 minutes each week for 104 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Intraocular Pressure with iCare

Change in Visual Field Mean Deviation with VisuALL

Secondary study objectives

Change in Visual Field Mean Deviation with Humphrey Field Analyzer

Other study objectives

Change in Retinal Nerve Fiber Layer (RNFL) Thickness

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Moderate GlaucomaExperimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard Automatic Perimetry Humphrey Field Analyzer

2019

N/A

~80

0 / 4Eligibility criteria met