Web-Based Visual Field Test for Glaucoma

Overseen By Andrew Pouw, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrew Pouw, MD

Disqualifiers: Non-English, Central vision disease, Neurocognitive, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a new visual field test for glaucoma, so it's unlikely that your current medications would be affected.

How is the EyeSimplify web-based visual field test for glaucoma different from other treatments?

The EyeSimplify web-based visual field test is unique because it allows patients to test their visual fields at home using a web browser, making it more accessible and convenient compared to traditional in-office tests. This approach is similar to other home-based visual field tests that use personal computers or virtual reality glasses, offering a flexible and potentially more frequent monitoring option for glaucoma patients. ^{1 2 3 4 5}

What data supports the effectiveness of the EyeSimplify web-browser-based visual field test for glaucoma?

Research shows that home-based visual field tests, like EyeSimplify, can be reliable for glaucoma screening when compared to traditional methods. Studies have found that similar online and portable visual field tests can effectively detect visual field loss in glaucoma patients, with some tests showing high sensitivity and specificity. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrew Pouw, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for glaucoma patients aged 18-100 who speak English and have a visual acuity of at least 20/80. It's not suitable for those with severe astigmatism, central vision-affecting diseases, or neurocognitive/psychiatric disorders that could interfere with testing.

Exclusion Criteria

I have a condition that affects my central vision.

Patients with best corrected visual acuity less than 20/80

Patients with astigmatism with absolute values greater than 2.00 diopters

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform at-home visual field tests using the EyeSimplify platform biweekly for six months

24 weeks

Biweekly at-home tests

Follow-up

Participants are monitored for adherence and user experience feedback after the treatment period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EyeSimplify web-browser-based visual field test

Trial Overview The study tests the EyeSimplify web-based visual field test on iPads to see if patients will stick to biweekly home testing over six months and how it compares to standard office-based tests in detecting glaucoma progression.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

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.

EyeSimplify web-browser-based visual field test is already approved in United States for the following indications:

Approved in United States as EyeSimplify for:

• Glaucoma-related visual field testing

Who Is Running the Clinical Trial?

Andrew Pouw, MD

Lead Sponsor

Trials

2

Recruited

70+

Published Research Related to This Trial

Remote training for glaucoma patients to use the Vivid Vision Perimetry (VVP-10) test at home is feasible, with 95% of participants successfully completing the test series after just one training session.

The VVP-10 showed excellent test-retest reliability (ICC of 0.95) and strong correlation with conventional perimetry results, suggesting it could be a reliable alternative for assessing visual function in glaucoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Remote Training, At-Home Testing, and Test-Retest Variability of a Novel Test for Clustered Virtual Reality Perimetry. Chia, ZK., Kong, AW., Turner, ML., et al.[2023]

A new home-based visual field examination method using a PC monitor or virtual reality glasses shows promise for glaucoma screening, demonstrating a good receiver operating characteristic curve (0.762 to 0.837) when compared to the standard Humphrey perimeter.

The method allows for self-testing and analysis of visual field results without specialized equipment, making it a potentially accessible option for early glaucoma detection, with sensitivity ranging from 0.637 to 0.942.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based visual field test for glaucoma screening comparison with Humphrey perimeter. Tsapakis, S., Papaconstantinou, D., Diagourtas, A., et al.[2022]

In a study of 79 participants with glaucoma or ocular hypertension, the tablet-based Melbourne Rapid Fields (MRF) and the IMOvifa Smart Visual Function Analyzer (SVFA) showed similar average mean deviation (MD) values to the Humphrey Field Analyzer (HFA), suggesting they can be viable alternatives for visual field testing.

However, significant differences in point sensitivity were observed, particularly with the MRF tablet overestimating sensitivity in the nasal field and underestimating it in the temporal field, indicating that while these devices may be useful for at-home monitoring, their results may vary significantly at specific locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Perimetric Outcomes from a Tablet Perimeter, Smart Visual Function Analyzer, and Humphrey Field Analyzer. Kang, J., De Arrigunaga, S., Freeman, SE., et al.[2023]

The Damato Multifixation Campimetry Online (DMCO) test shows high specificity (up to 98.1%) and varying sensitivity for detecting glaucomatous visual field loss, with 100% sensitivity for advanced and severe glaucoma cases, based on a study of 97 individuals.

The most effective interpretation algorithm for DMCO results was found by combining two successive DMCO STANDARD tests, indicating that this online tool could be a valuable resource for glaucoma detection, especially in a preselected population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glaucoma detection with damato multifixation campimetry online. Olsen, AS., Alberti, M., Serup, L., et al.[2018]

The novel visual field application on a portable augmented-reality headset shows excellent correlation with the standard Humphrey field analyzer, with a Pearson correlation coefficient of 0.94 for mean sensitivity and 0.95 for mean deviation, based on a study of 89 patients.

The analysis indicates that the Heru visual field test has a small mean difference compared to the Humphrey test, suggesting it is a reliable alternative for assessing visual fields in patients with and without glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Visual Field Test Measurements With a Novel Approach on a Wearable Headset to Standard Automated Perimetry. Johnson, C., Sayed, A., McSoley, J., et al.[2023]

Specvis is a free and open-source application designed for visual field examination, which can run on any personal computer, making it an accessible tool for diagnosing visual impairments, especially in underdeveloped regions.

In validation studies involving patients with glaucoma, retinitis pigmentosa, and stroke, Specvis demonstrated low variability and reliable results compared to the Medmont M700 Automated Static Perimeter, indicating it can effectively identify areas of visual field impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specvis: Free and open-source software for visual field examination. Dzwiniel, P., Gola, M., Wójcik-Gryciuk, A., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of Remote Training, At-Home Testing, and Test-Retest Variability of a Novel Test for Clustered Virtual Reality Perimetry. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Home-based visual field test for glaucoma screening comparison with Humphrey perimeter. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of Perimetric Outcomes from a Tablet Perimeter, Smart Visual Function Analyzer, and Humphrey Field Analyzer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Glaucoma detection with damato multifixation campimetry online. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of Visual Field Test Measurements With a Novel Approach on a Wearable Headset to Standard Automated Perimetry. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Specvis: Free and open-source software for visual field examination. [2019]