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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 minutes each week for 104 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 20 and 80 years old.
Select...
I have been diagnosed with mild or moderate open angle glaucoma.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Intraocular Pressure with iCare
Change in Visual Field Mean Deviation with VisuALL
Secondary outcome measures
Change in Visual Field Mean Deviation with Humphrey Field Analyzer
Other outcome measures
Change in Retinal Nerve Fiber Layer (RNFL) Thickness
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
Find a Location
Who is running the clinical trial?
Wills EyeLead Sponsor
79 Previous Clinical Trials
10,386 Total Patients Enrolled
M. Reza Razeghinejad, MDPrincipal InvestigatorWills Eye Hospital
1 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to participate in the study.I am between 20 and 80 years old.I have a condition affecting my vision, not including glaucoma or mild/moderate cataracts.I had cataract surgery, with or without glaucoma surgery, less than 3 months ago.I have not had any filtering surgeries in the last 6 months.I have taken medication that could affect my vision or reaction time.I can't use the device even after being trained remotely.I had eye surgery, but it was over 90 days ago and not for complicated conditions.I have been diagnosed with mild or moderate open angle glaucoma.
Research Study Groups:
This trial has the following groups:- Group 1: Moderate Glaucoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining positions available in this research study?
"As of now, this research venture is actively searching for patients according to clinicaltrials.gov; the trial was initially posted on April 15th 2022 and most recently revised on April 25th 2022."
Answered by AI
What is the total number of individuals participating in this research endeavor?
"Affirmative. Clinicaltrials.gov displays that this experiment, which was first announced on April 15th 2022, is actively recruiting participants. 50 individuals must be acquired from 1 medical facility to properly conduct the trial."
Answered by AI
Does this research trial consider people aged 45 and over as viable participants?
"This clinical trial permits individuals aged 20 to 80 to partake. Conversely, 23 trials are available for participants younger than 18 whereas 200 studies are accessible for those above 65 years of age."
Answered by AI
Who is eligible for enrollment in this experiment?
"In order to be eligible for this medical trial, potential candidates must have glaucoma of the open-angle variety and should fall within the age range between 20 to 80. This clinical study seeks a total of 50 participants."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I hope that this trial will help address my glaucoma and help me know if it is getting worse or if it is stabilized.
PatientReceived no prior treatments
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