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

NCT05690152 | Terminated Results FDA Device

• 1 other identifier: 202207403
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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. 1.How adherent patients are to biweekly testing at home for 6 months, and
2. 2.How patients feel the ease of user experience of the test was, and
3. 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• EyeSimplify Self-Test Adherence

  For the purposes of this study, adherence is defined as number of times a subject self-tests divided by the number of times they are expected to self-test during the six-month study period. There will be a total of 14 expected self tests. Adherence will be evaluated at the conclusion of the six-month study period.

  Subjects will be asked to self-test once every two weeks for six months.

• EyeSimplify Self-Test Persistence

  For the purposes of this study, persistence is defined as the number of consecutive self-tests a subject completes without a lapse. Persistence will be evaluated at the conclusion of the six-month study period.

  Subjects will be asked to self-test once every two weeks for six months.

Secondary Outcomes (21)

• Visual Field Reliability Metric #1 - False Positive Rate

  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.

• Visual Field Reliability Metric #2 - False Negative Rate

  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.

• Visual Field Reliability Metric #3 - Fixation Loss Rate

  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.

• Visual Field Performance Metric #1 - Mean Deviation

  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.

• Visual Field Performance Metric #2 - Pattern Standard Deviation

  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.

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Device: EyeSimplify web-browser-based visual field test

Interventions

EyeSimplify web-browser-based visual field test DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew Pouw, MD: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (4)

• Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.

  PMID: 8695555 BACKGROUND

• Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.

  PMID: 16488940 BACKGROUND

• 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.

  PMID: 3974997 BACKGROUND

• 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.

  PMID: 33443958 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Andrew Pouw, MD
• Organization: University of Iowa Hospitals and Clinics Department of Ophthalmology and Visual Sciences

andrew-pouw@uiowa.edu

319-356-3938

Study Officials

• Andrew Pouw, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 19, 2023
• Study Start: February 6, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: May 18, 2026
• Results First Posted: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)