Clinical trial NCT05690152: Persistence of Glaucoma Patients With Web-Browser-Based Visual Field Test
Official title: Persistence of Glaucoma Patients With Web-Browser-Based Visual Field Test
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: EyeSimplify Self-Test Adherence
timeFrame: Subjects will be asked to self-test once every two weeks for six months.
measure: EyeSimplify Self-Test Persistence
timeFrame: Subjects will be asked to self-test once every two weeks for six months.
Secondary outcomes:
measure: Visual Field Reliability Metric #1 - False Positive Rate
timeFrame: This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. Testing will occur every two weeks for the six-month study period.
measure: Visual Field Reliability Metric #2 - False Negative Rate
timeFrame: This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. Testing will occur every two weeks for the six-month study period.
measure: Visual Field Reliability Metric #3 - Fixation Loss Rate
timeFrame: This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. Testing will occur every two weeks for the six-month study period.
measure: Visual Field Performance Metric #1 - Mean Deviation
timeFrame: This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. Testing will occur every two weeks for the six-month study period.
measure: Visual Field Performance Metric #2 - Pattern Standard Deviation
timeFrame: This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. Testing will occur every two weeks for the six-month study period.
measure: Visual Field Performance Metric #3 - Total Deviation
timeFrame: This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. Testing will occur every two weeks for the six-month study period.
measure: Visual Field Performance Metric #4 - Foveal Threshold
timeFrame: This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. Testing will occur every two weeks for the six-month study period.
measure: Visual Field Loss Trend Metric #1 - Guided Progression Analysis Trend Analysis
timeFrame: This measurement will automatically be generated after five Humphrey visual field tests and is updated with each subsequent test. Subjects will only complete one Humphrey visual field during the study, so this metric will be taken from historic data.
measure: Visual Field Loss Trend Metric #2 - EyeSimplify Mean Deviation Progression Trend
timeFrame: This measurement will automatically be generated after five EyeSimplify visual field tests and is updated with each subsequent test. This metric will be recorded upon completion of the six-month study period.
measure: EyeSimplify User Experience Question #1 - "Please select what type of device you used to take your EyeSimplify visual field tests."
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #2 - "Please describe what accessories, if any, you used to take your EyeSimplify visual field tests."
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #3 - "How hard or easy was it for you to achieve a comfortable testing environment for yourself while using the EyeSimplify online test?"
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #4 - "How hard or easy was it for you to achieve a functional testing environment for yourself while using the EyeSimplify online test?"
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #5 - "What time of day did you typically take your EyeSimplify visual field tests?"
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #6 - "Please describe the level of ambient light you typically took your EyeSimplify visual field tests in."
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #7 - "Did you ever have to block out ambient light using curtains or other methods when taking your EyeSimplify visual field tests?"
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #8 - "How hard or easy was it for you to navigate the EyeSimplify website?"
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #9 - "How hard or easy was it to understand the instructions for the visual field test using EyeSimplify?"
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #10 - "How much anxiety or concern did you have about your test performance while using the EyeSimplify online visual field test?"
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #11 - "How confident were you taking the EyeSimplify visual field test by yourself at home?"
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
measure: EyeSimplify User Experience Question #12 - "If EyeSimplify visual field testing were available for regular home use outside of this study, would you use it?"
timeFrame: Subjects will respond to an approximately 5-10 minute survey at the conclusion of the six-month study period.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Andrew Pouw, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Beck RW, Bergstrom TJ, Lichter PR. A clinical comparison of visual field testing with a new automated perimeter, the Humphrey Field Analyzer, and the Goldmann perimeter. Ophthalmology. 1985 Jan;92(1):77-82. doi: 10.1016/s0161-6420(85)34065-4.
citation: Prager AJ, Kang JM, Tanna AP. Advances in perimetry for glaucoma. Curr Opin Ophthalmol. 2021 Mar 1;32(2):92-97. doi: 10.1097/ICU.0000000000000735.