Implementation of the NEDS EyeCTester App

NCT04607369 | Enrolling By Invitation FDA Device

• 1 other identifier: 20190049
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Optic Nerve Disease; Macular Disease; Visual Pathway Disorder

Keywords

Amsler Grid; Visual Field Defects; 10-2 Visual Field; Optic Nerve Diseases; Macula Diseases; Visual Pathway Disorders; Vision Monitoring

Outcome Measures

Primary Outcomes (3)

• Primary Outcome Measure for Groups 4a and 4b:

  The Test-Retest Repeatability for the identified three common near-vision procedures will be measured to determine sample sizes to reach the objectives of this study. Patients will be recruited from a neuro-ophthalmology and/or retina clinic's new or established patient population. Thirty willing patients with known Amsler grid abnormalities (metamorphopsia, scotoma, field-cut field-cut) will each complete the study protocol. Test results will be statistically analyzed to compare the app test with the in-office paper test versions. This analysis will allow the population size to be measured which is needed for valid test results.

  Study was conducted for each patient in one day.

• Secondary Outcome Measure for Groups 4a and 4b

  The limits of agreement will be reported by comparing the difference in measurements taken using In Clinic Near Vision Tests (ICNVT) vs Smart Phone Near Vision Tests (SPNVT). The investigators will determine the 95% limits of agreement by calculating the mean difference between ICNVT and SPNVT as well as the standard deviation. Histograms will be used to verify that the data is normally distributed. If the data is not normally distributed appropriate statistical transformation will be made by working directly with ratios. Once population size is determined with Objective 1 via test-retest, the investigators will then determine the limits of agreement between testing using SPNVT and ICNVT for patients known to have eye abnormalities that meet the inclusion/exclusion criteria. The first hypothesis is that testing using the SPNVT will be within a 95% limit of agreement with testing using ICNVT. The second hypothesis is that SPNVT will be non-inferior to ICNVT.

  Study was conducted for each patient in one day.

• Primary Outcome Measure for Groups 7a and 7b

  The The Test-Retest Repeatability for the identified three common near-vision procedures will be measured to determine sample sizes to reach the objectives of this study.

  Study was conducted for each patient in one day.

Study Arms (7)

Groups in General all were done under the wcgIRB, even those that were Practice groups

Groups 1-3 were practice groups, gathering smartphone app installation, functional and usability feedback in preparation for later phase groups Groups 4a and 4b Cohort 1 and 2 is the FDA application finalized and submitted study groups Group 5-6 currently in continuing clinical trial during FDA application process

Device: EyeCTester

1-3,5 Developmental team(1), Technician(2) and Non-Clinical Groups(3) 5. Retinal practice

Individuals on the developmental team, staff members and outside clinic people 5 Retinal Practice (to do after FDA approval)

Device: EyeCTester

4a. Cohort 1. FDA group

Patients in Neuro-Ophthalmology of Texas (NOT) PLLC practice which has referrals from multiple practices including retinal patients.

Device: EyeCTester

4b. Cohort 2. FDA group

Patients in NOT practice

Device: EyeCTester

6 At Home use of app in continuing clinical trial during FDA decision

Patients are educated on the app at home via app video clips and brochure, and as necessary, online training with COA (ophthalmic assistants/technicians or other trained educators) in order to do remote physiologic vision monitoring or preclinic near vision check.

Device: EyeCTester

7a Cohort 1 FDA group responding to AI

Normal patients were tested with standard near vision tests compared with the smartphone app near vision tests. All patients were trained at home with app videos and by COA via telemedicine before coming to clinic.

Device: EyeCTester

7b Cohort 2 FDA group responding to AI

Normal patients were tested with standard near vision tests compared with the smartphone app near vision tests. All patients were trained at home with app videos and by COA via telemedicine before coming to clinic.

Device: EyeCTester

Interventions

EyeCTester DEVICE

Smartphone app that allows vision testing

1-3,5 Developmental team(1), Technician(2) and Non-Clinical Groups(3) 5. Retinal practice; 4a. Cohort 1. FDA group; 4b. Cohort 2. FDA group; 6 At Home use of app in continuing clinical trial during FDA decision; 7a Cohort 1 FDA group responding to AI; 7b Cohort 2 FDA group responding to AI; Groups in General all were done under the wcgIRB, even those that were Practice groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

For FDA approval Cohort 4a and 4b are the 2 groups being evaluated.

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• A normal Amsler Grid with no scotoma or field-cut. Patients without Amsler defects are not the intended population of this study.
• 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.
• Study Criteria for Group 7
• Age Limits:22 and over
• 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.
• Patients younger than 22

Sponsors & Collaborators

• Neuro-Eye Diagnostic Systems, LLC: lead
• Neuro-ophthalmology of Texas PLLC: collaborator

Study Sites (1)

Neuro-ophthalmology of Texas, PLLC

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Conditions

Optic Nerve Diseases; Macular Degeneration

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases

Study Officials

• Rosa A Tang, MD

  Neuro-ophthalmology of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 29, 2020
• Study Start: January 9, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: If FDA approval we will publish this data
• Access Criteria: Access all of the above after publication

Locations

US (1)