Trial Outcomes & Findings for Persistence of Glaucoma Patients With Web-Browser-Based Visual Field Test (NCT NCT05690152)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

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

Results posted on

2026-05-18

Participant Flow

All patients were assigned to a single arm.

Participant milestones

Participant milestones
Measure	Single Arm 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: 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.
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm 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: 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.
Overall Study Study terminated prematurely due to discontinuation of testing software by third party.	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=8 Participants 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: 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.
Age, Categorical <=18 years	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=11 Participants
Age, Categorical >=65 years	2 Participants n=11 Participants
Age, Continuous	56.5 Years STANDARD_DEVIATION 13.4 • n=11 Participants
Sex: Female, Male Female	6 Participants n=11 Participants
Sex: Female, Male Male	2 Participants n=11 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants
Race (NIH/OMB) Asian	0 Participants n=11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants
Race (NIH/OMB) Black or African American	1 Participants n=11 Participants
Race (NIH/OMB) White	7 Participants n=11 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
Region of Enrollment United States	8 participants n=11 Participants

PRIMARY outcome

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

Population: Study withdrawn before any subjects could complete the specified study duration, so while 8 subjects were recruited, final results could not be analyzed and values reported below may be skewed by the total number of tests each subject was able to complete.

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.

Outcome measures

Outcome measures
Measure	Single Arm n=40 Tests 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: 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 Self-Test Adherence	94.32 percentage of tests completed Standard Deviation 13.38

PRIMARY outcome

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

Population: Study withdrawn before any subjects could complete the specified study duration, so while 8 subjects were recruited, final results could not be analyzed and values reported below may be skewed by the total number of tests each subject was able to complete.

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.

Outcome measures

Outcome measures
Measure	Single Arm n=40 Tests 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: 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 Self-Test Persistence	4.00 Consecutive Tests Standard Deviation 3.43

SECONDARY outcome

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.

Population: Study withdrawn before any subjects could complete the specified study duration, so while 8 subjects were recruited, final results could not be analyzed and values reported below may be skewed by the total number of tests each subject was able to complete.

In perimetry (visual field testing), a "false positive error" occurs when a subject/patient records a response when no stimulus is presented. This is one metric by which the reliability of a visual field test is measured. The measurement is reported as a percentage.

Outcome measures

Outcome measures
Measure	Single Arm n=40 Tests 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: 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.
Visual Field Reliability Metric #1 - False Positive Rate	8.64 Percentage of FPs Standard Deviation 12.00

SECONDARY outcome

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.

Population: Ultimately, FNs were not collected due to evidence suggesting it is not indicative of true test reliability versus FP rates (PMID: 28676280). Additionally, the testing software has been discontinued, so we are unable to retroactively obtain this data.

In perimetry (visual field testing), a "false negative error" occurs when a subject/patient fails to record a response to a stimulus that is brighter than one they had previously responded to in the same visual location. This is one metric by which the reliability of a visual field test is measured. The measurement is reported as a percentage.

Outcome measures

Outcome data not reported

SECONDARY outcome

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.

Population: Ultimately, FLs were not collected due to evidence suggesting it is not indicative of true test reliability versus FP rates (PMID: 28676280). Additionally, the testing software has been discontinued, so we are unable to retroactively obtain this data.

In perimetry (visual field testing), a "fixation loss" occurs when a subject/patient records a response to a stimulus presented in the physiologic blind spot. If the patient responds, it indicates their gaze is not fixed straight ahead. This is one metric by which the reliability of a visual field test is measured. The measurement is reported as a percentage.

Outcome measures

Outcome data not reported

SECONDARY outcome

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.

Population: Study withdrawn before any subjects could complete the specified study duration, so while 8 subjects were recruited, final results could not be analyzed and values reported below may be skewed by the total number of tests each subject was able to complete.

Mean deviation indicates how much, on average, an entire visual field deviates from the age-normal value. It is the center-weighted average of the decibel deviations at each point tested in the visual field test. The measurement is reported in decibels.

Outcome measures

Outcome measures
Measure	Single Arm n=40 Tests 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: 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.
Visual Field Performance Metric #1 - Mean Deviation	-12.50 dB Standard Deviation 8.24

SECONDARY outcome

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.

Population: Study withdrawn before any subjects could complete the specified study duration, so while 8 subjects were recruited, final results could not be analyzed and values reported below may be skewed by the total number of tests each subject was able to complete.

Pattern standard deviation reflects irregularities in a visual field, such as those caused by localized defects. This metric shows sensitivity losses after adjusting for generalized depression or elevation in the overall hill of vision (e.g. cataracts). The measurement is reported in decibels.

Outcome measures

Outcome measures
Measure	Single Arm n=40 Tests 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: 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.
Visual Field Performance Metric #2 - Pattern Standard Deviation	7.36 dB Standard Deviation 1.94

SECONDARY outcome

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.

Population: As TD represents the data for individual test locations within the visual field and our intention was evaluate patient adherence/persistence with this testing modality, we ultimately decided not to record this information. Additionally, since the testing software has been discontinued, we are unable to collect this data retroactively.

Total deviation probability plots identify test locations that are outside normal limits. Threshold sensitivity levels are compared to age-corrected normal values at each test location to produce a total deviation map. Each measurement is reported in decibels.

Outcome measures

Outcome data not reported

SECONDARY outcome

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.

Population: Study withdrawn before any subjects could complete the specified study duration, so while 8 subjects were recruited, final results could not be analyzed and values reported below may be skewed by the total number of tests each subject was able to complete.

Foveal threshold is the minimum amount of luminance increment on a uniform background that can be detected by a subject/patient at the center of fixation. The measurement is reported in decibels.

Outcome measures

Outcome measures
Measure	Single Arm n=40 Tests 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: 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.
Visual Field Performance Metric #4 - Foveal Threshold	18.42 dB Standard Deviation 8.65

SECONDARY outcome

Timeframe: This measurement will automatically be generated after five Humphrey visual field tests and is updated with each subsequent test.

Population: GPA data was not available for any of the recruited subjects because: 1) not all subjects completed an HFA visual field test during the study duration and 2) among subjects who did complete an HFA visual field during their time in the study, none completed more than one.

Guided Progression Analysis (GPA) is a visual field analysis aid used to quantify visual field progression. This analysis aid is specific to Humphrey perimeters. The GPA Trend Analysis component quantifies the observed rate of change of the visual field. This metric is reported as percent loss per year (VFI) OR estimated mean deviation decibel loss per year, along with confidence limits for the slope estimate.

Outcome measures

Outcome data not reported

SECONDARY outcome

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.

Population: As above, this metric was intended to be recorded upon study completion. Since no subjects completed the full study period, no progression trend data was recorded. Additionally, this analysis was a feature of EyeSimplify (not reported on individual test reports) and is no longer available for us to retrieve as the platform has been discontinued.

The EyeSimplify Progression Trend is a visual field analysis aid used to quantify visual field progression. This analysis aid is specific to EyeSimplify and quantifies the observed rate of change of subjects' mean deviation. This metric is reported as estimated decibel loss per year.