Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT04607369
Eligibility Criteria:
Inclusion Criteria for 4a and 4b:
The participant must have at least one eye which complies with all the inclusion criteria
Inclusion criteria:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. The patient's eyes should not be dilated.
9. The patient should have a static ophthalmic condition as determined by the sponsor that is not causing pain or discomfort and is not expected to change in the short timeframe between tests. Patients with recent eye surgery, should be stable as documented by Q \& A with patient's eye care provider or in the patient's medical record if access is available.
Exclusion Criteria:
The participant must have at least one eye which complies with none of the exclusion criteria listed below.
1. A normal Amsler Grid with no scotoma or field-cut. Patients without Amsler defects are not the intended population of this study.
2. 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.
3. 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.
4. In the study eye, a scotoma or field-cut that is larger than 90% of the Amsler grid (90 cm2 or 360 squares).
5. 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.
6. Overlapping scotomas or field-cuts to all the scotomas present, because they add complexity to the study without adding value to the study results.
7. 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.
8. 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.
Study Criteria for Group 7
Age Limits:22 and over
1. Inclusion Criteria for 7A and 7B:
* Must be 22 years old or older.
* Have already been seen or will be seen by an optometrist or ophthalmologist.
* Have normal vision as defined as best corrected vision of 20/20 or better.
* Have a normal posterior pole OCT.
* Have signed the informed consent.
2. Exclusion Criteria:
* Patients younger than 22
* Have a visual acuity worse than 20/20
* Have macula pathology based on an abnormal posterior pole OCT exam
* Have conditions that can interfere with Amsler grid testing for example tremors, trouble focusing, due to moving eyes (nystagmus) or trouble with concentration (e.g., ADDH) or cognition problems, based on known diagnoses in the chart or if history is obtained of these conditions during enrollment.
* Individuals who fail the test in the office after training
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04607369
Study Brief:
Protocol Section:
NCT04607369