Clinical trial: Implementation of the NEDS EyeQTester App (NCT04607369)

Eligibility criteria:
Inclusion Criteria:

        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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism.  The patient was born at 38 weeks gestation with no complications.  Vital signs are normal.  Weight and height are at the 50th percentile.  On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination.  Optic nerves are small and gray.  All the hairs including eyebrows and lashes are white.

Patient description (patient's own words): I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray.

Does the patient match the trial criteria? Contradiction