Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690152
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2023-01-03
Brief Title:
Persistence of Glaucoma Patients With Web-Browser-Based Visual Field Test
Sponsor:
Andrew Pouw MD
Organization:
University of Iowa
Study Overview
Official Title:
Persistence of Glaucoma Patients With Web-Browser-Based Visual Field Test
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MS 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 platforms ease of usability and user experience
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 platforms 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 MS 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 drivers licensecredit cardID 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
MS Technologies is the developer of the EyeSimplify visual field test platform As the developers MS 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 MS Technologies does not have access to any additional patient information
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 drivers licensecredit cardID 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
MS Technologies is the developer of the EyeSimplify visual field test platform As the developers MS 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 MS Technologies does not have access to any additional patient information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None