Persistence of Glaucoma Patients With Web-Browser-Based Visual Field Test

Andrew Pouw, MD

Status: Withdrawn

Conditions: Glaucoma

Treatments: Device: EyeSimplify web-browser-based visual field test

Study type: Interventional

Funder types: Other

Identifiers

NCT05690152

202207403

Details and patient eligibility

About

The goal of this clinical trial is to assess patient persistence and adherence with a 6-month period of at-home visual field testing, using a novel web-based visual field test (EyeSimplify, M&S Technologies, Niles, IL).

The main questions this clinical trials aims to answer are:

1. How adherent patients are to biweekly testing at home for 6 months, and
2. How patients feel the ease of user experience of the test was, and
3. Whether the EyeSimplify platform is able to detect any worsening of glaucoma-related visual field performance that can be corroborated by standard of care, office-based testing.

Participants will be given iPads with links to the EyeSimplify visual field test, and asked to take the EyeSimplify tests at home biweekly for six months. The test takes between 10 to 15 minutes to do and participants will have no additional responsibilities between tests.

Researchers will send reminders for patients to complete the at-home tests at periodic intervals, and if worsening on the at-home test platform is suggested by test results, researchers will arrange for return visits to the office to compare the EyeSimplify test results to standard-of-care, office-based testing. At the conclusion of the study, participant adherence to the 6-month biweekly testing schedule will be assessed and participants will be surveyed for their perceptions regarding the EyeSimplify platform's ease of usability and user experience.

Full description

The purpose of this prospective study is to assess patient persistence and adherence with a 6-month period of at-home visual field testing using an iPad with a novel web-browser-based visual field test, the EyeSimplify platform (M&S Technologies, Niles, IL). Use of this test is intended to supplement, but not replace, regular clinic visits.

The proposed study will be conducted at the University of Iowa Hospitals and Clinics. We estimate 50 subjects will be recruited to participate in the study. Data collected will not include patient identifiers, but will instead be coded.

The research will involve prospective collection of visual field tests. Patients with suspected, mild, moderate, or severe glaucoma will be included. Clinical data including age, gender, ethnicity, visual acuity, intraocular pressure, severity of disease, past and comparative Humphrey HFA-III visual field test performance, EyeSimplify visual field test performance, and EyeSimplify usability survey will be recorded.

Following study recruitment, subjects will be asked to take EyeSimplify visual field tests at home biweekly for six months. They will have no additional responsibilities between tests. Subjects will access the EyeSimplify web browser on an iPad provided by the research team, using a link and login credentials provided to them by a research assistant. Upon logging into the EyeSimplify web browser, subjects will click the "Start Test" button found along the left side of the window and follow the prompts presented on screen to calibrate their screen. Screen calibration involves holding a driver's license/credit card/ID to the screen to ensure the test window is the appropriate dimensions. Following screen calibration, subjects will follow the test prompts presented on screen to complete their visual field test. Test results are automatically sent to the research assistant who issued the exam, so subjects may exit the browser after each test. Upon study completion, subjects will be asked to fill out a brief user experience survey.

M&S Technologies is the developer of the EyeSimplify visual field test platform. As the developers, M&S Technologies maintains a secure, encrypted, HIPAA-compliant database of test participants. This database includes patient profiles containing unique subject IDs (de-identified), birth year (but not specific date), and visual field testing results. Outside of this testing information, M&S Technologies does not have access to any additional patient information.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 18-100 years of age with suspected, mild, moderate, or severe glaucoma

Exclusion criteria

• Non-English speakers, patients with systemic or ocular disease affecting central vision, best corrected visual acuity less than 20/80, neurocognitive or psychiatric disorders that would confound visual field testing, those with physical inability to perform testing, and astigmatism with absolute values greater than 2.00 diopters

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single Arm

Experimental group

Description:

All patients will be in a single arm: patients will have one or both eyes (dependent on inclusion/exclusion criteria) tested with the EyeSimplify visual field test biweekly for 6 months.

Treatment:

Device: EyeSimplify web-browser-based visual field test