Implementation of the NEDS EyeCTester App (NCT04607369) | Clinical Trial Compass
By InvitationNot Applicable
Implementation of the NEDS EyeCTester App
United States100 participantsStarted 2019-01-09
Plain-language summary
Group 4a and 4b was an FDA trial that showed that patients who have an Amsler grid abnormality on paper, have a similar abnormality on the app.
Group 7a and 7b was an FDA trial that showed that normal patients do not have false positives on the Amsler app as well as on the Amsler paper version. Further Vision on the app is slightly better than vision on the standard Sloan near card using a formula (vision is 7/10th of a line better on the app).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients have had a standard ICNVT in the last six months which could potentially qualify a patient's eye for study participation. This information will be used to determine whether to proceed with screening the patient with the remaining study selection criteria below.
. In the proposed study eye, the patient has at least one scotoma or field-cut, metamorphopsia or doubling area that is non-overlapping and that has boundaries separated by more than 1 degree (the appendix describes "degree" measurements more fully). This means that if there are many scotoma's or areas of metamorphopsia or doubling, all but one is overlapping, the one that is not overlapping with required separation does qualify for the trial, while the others do not.
. Age 18 or above 18 years old was selected as the minimum age because this study is only intended to evaluate patients who will follow directions well and can sign the consent alone.
. If the patient uses corrective lenses, then if needed we will provide patients with an ophthalmologist configured optical trial lens frame with lenses configured to provide their near vision correction at 16 inches. We do this to eliminate the effect of multifocal or progressive lens viewing issues at near (from viewing through the wrong portion of the lens) on testing results. In a future study, potentially in this same trial, we may examine the effect of personal lenses on testing results. The patient must be able to tolerate wearing the optical trial frame without discomfort or problems viewing in these lenses.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Outcome Measure for Groups 4a and 4b:
Timeframe: Study was conducted for each patient in one day.
2
Secondary Outcome Measure for Groups 4a and 4b
Timeframe: Study was conducted for each patient in one day.
3
Primary Outcome Measure for Groups 7a and 7b
Timeframe: Study was conducted for each patient in one day.
. Able to perform a short test provided in the clinic to measure if the patient can work with both the paper Amsler Grid as well as the Smart-phone Amsler grid. This test will be evaluated with standardized review and scoring by the Educator of the patient's performance, which will require an 80 percent score or better. The idea of this test is to be certain the combination of cognitive, motor and visual abilities of the patient is at the level that can easily for hold the paper grid (on a small clipboard) as well as hold the smart-phone in hand and for both modalities be steady enough to understand how to draw and to be able to draw on the paper and smart-phone Amsler grid per directions of the Educator. The provided iPhone 6 is technically similar to recent smart-phone models and demonstrates ease of use as tested by our team.
. Visual acuity is to be no worse than 20/80 (LogMAR +0.50) at a viewing distance of 16 inches. At this distance the letter size will be 1.86 mm tall.
. The patient must have the ability to directly focus on a 2.5 mm fixation point. This target is the size of the 20/80 Sloan optotype (LogMAR +0.50). In this fashion we can mostly ensure that direct, rather than eccentric viewing is performed. Eccentric viewing is not optimum for this trial as it may interfere with test repeatability if the eccentric viewing patient is not consistently using the same portion of their eye to view the test. Were this the case, the scotoma/field-cut positions may vary. It is acceptable for a scotoma or a field-cut to impinge on the fixation point as long as the density of the scotoma or a field-cut does not prevent direct viewing of the fixation point. The Eye Examiner EE (including the ophthalmologist and educator) will monitor and document whether the patient appears to be using direct visualization of the chart.
. The patient's eyes should not be dilated.
Exclusion criteria
. A normal Amsler Grid with no scotoma or field-cut. Patients without Amsler defects are not the intended population of this study.
. Before the education session, should the patient exhibit cognitive, motor problem (weakness, tremor, ataxia, etc.) or visual problems that prevent the patient from independently performing one or more of the near vision tests via the standard ICNVT or via SPNVT as described above in item 5 of Inclusion criteria.
. Dilation of either eye on the day of and day prior to the trial examination because it limits accommodation as well as may increase in light sensitivity.
. In the study eye, a scotoma or field-cut that is larger than 90% of the Amsler grid (90 cm2 or 360 squares).
. In the study eye, the patient has scotomas or field-cuts, all of which are smaller than 0.0013% of the Amsler grid (0.13 cm2 or 1/2 of one Amsler grid square). Such small sized scotomas or field-cuts may reduce drawing accuracy on both Amsler Grid tests and may be undetectable on the 10-2.
. Overlapping scotomas or field-cuts to all the scotomas present, because they add complexity to the study without adding value to the study results.
. Two or more unreliable Visual Field test results. During the study, patient's visual field, will be tested using the Zeiss Humphrey® Field Analyzer 10-2 which will produce a "Single Field" outcome that includes reliability indices. The HFA 10-2 measurement to be carried out using the SITA standard test and the standard Goldmann III stimulus size. Only reliable VFs to be used in the analyses, defined as a fixation loss (FL) rate \< 20% and a false-positive (FP) rate \< 15%, following the manufacturer's recommendation for SITA measurements.
. Should the patient appear to have unreliable parameters by 10-2 testing with one test, this test will not be evaluated, however, should the second 10-2 test be reliable, this test will be used to compare with the Amsler Grid results.