Optic Nerve DiseaseNCT04607369
Implementation of the NEDS EyeCTester App
An observational study of Optic Nerve Disease and Macular Disease, run by Neuro-Eye Diagnostic Systems, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Nerve Disease, Macular Disease, Visual Pathway Disorder
- What is being tested?
- EyeCTester
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For FDA approval Cohort 4a and 4b are the 2 groups being evaluated.
Who may be able to join
- The participant must have at least one eye which complies with all the 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.
- 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.
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- 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.
Who cannot join
- The participant must have at least one eye which complies with none of the exclusion criteria listed below.
- 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.
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- 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
- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Neuro-ophthalmology of Texas, PLLC
Bellaire, Texas, 77401
About this study
Official title: Implementation of the NEDS EyeCTester App and NEDS Server Analysis Software Into the Homes of Patients With Neuro-ophthalmic, Retinal and Other Diseases to Enhance Early Detection of Active Eye Disease.
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).
Read the detailed description
Detailed Description of 4A and 4B: A series of patients with central visual defects were identified and their names were given to the unblinded clinical coordinator. The clinical coordinator contacted the patients, described the study, arranged the appointments to come to the clinic one-at-a-time for a dedicated visit to participate in the study. Each patient experienced the same study process for their visit:
- Met with the unblinded Clinical Coordinator who had the patient sign the informed consent after detailed explanation.
- Had the Clinical Coordinator put a number tag on the patient, and this was the number that the blinded participants of the study were to use for these subjects. Additionally, random numbers were used on the test forms.
- Patients met with blinded test trainer where the patient was provided standardized instruction for use of Amsler grid on-paper test, the Amsler grid on EyeQTester device, visual acuity and color sensitivity on paper and on the device. The instruction was enhanced between Cohort 1 and Cohort 2 as approved by the IRB for the different instruction protocol (see below discussion). Also, patients were given a test which they must pass in order to enter the trial.
- Patients then met with the blinded test administrator where the patient took the tests with no coaching. The test admin confirmed that the environmental parameters were similar across all patients over the course of the study.
- The patient completed test and re-test sequences.
- All test results with assigned random numbers were reported by the test administrator to the Clinical Coordinator who provided batches of blinded results to the Data Coordinator.
The investigators knew from prior clinic experience that the patients required a new and more detailed educational experience than was standard in order to have more reliable results for both the paper and app Amsler Grid test, in order to measure the central visual fields. The investigators focused on carefully training the patient through both written material and a video where the educational administrator was there to review this with the patient. The education focused on:
- What are "defects" and how to identify and report them.
- How to draw the above defects with attention to distance from the fixation point, size of the defect as well as its density.
Training enhancement was prompted midway through the trial, when the unblinded sponsor and clinical coordinator reviewed patient test results. Initial conclusion was that the patients exhibited defect identification on both paper and app that could possibly be enhanced by improving the educational protocol. An updated educational protocol was provided which the sponsor discussed with the educational team which was implemented to test if this updated patient education would result in more reliable results. It was decided to utilize updated educational approach for all patients on both paper and the app. Additionally, the investigators, added a stylus for the app (replacing the patient's finger) in order to more closely simulate a pen which is utilized for the paper. This updated approach was submitted and approved by the IRB.
As a result of the above, a decision was made to have two cohorts in the study, the early education cohort 1 and the later education cohort 2. Patients in cohort 1 were trained on the device to draw a defect on the screen with the tip of their finger but on paper to use a pen. Patients in cohort 2 were trained on the device to draw a defect on the screen with a stylus and on paper with a pen. The result in Cohort 2 was that consistency of the patients test results were better for both test and re-test for both the Amsler grid on-paper and the EyeCTester device.
The statistical analysis in this report shows the overall results and also the improved results in Cohort 2 that likely is attributed to these educational enhancement and stylus additions.
The full protocol for the trial including the training is available in the WIRB trial documentation.
Sample Size Calculation by our statistician was verified to be the sample size used was statistically acceptable.
Summary: Amsler app and paper version were equivalent, and best when using a stylus on the app.
Detailed Description of 7A and 7 B A series of patients 22 and over without any vision problems being examined similar to the above (see WIRB description) with a different education protocol consisting of in-home video on the app, telemedical connection by COA to confirm teaching was understood, and if not reteach.
The statistical analysis in this report shows the overall results showed that the vision testing standard and app were similar, with better vision tested on the app, by a formula that approximates, 7/10 of a line better.
The statistical analysis in this report shows the overall results showed that the color testing standard and app were similar.
The statistical analysis in this report shows the overall results showed that the Amsler grid testing via standard near vision tests and app were exactly the same with neither having false positives.
The full protocol for the trial including the training is available in the WIRB trial documentation.
Sample Size Calculation by our statistician was verified to be the sample size used was statistically acceptable.
- Being tested
- EyeCTester
- Keywords
- Amsler Grid, Visual Field Defects, 10-2 Visual Field, Optic Nerve Diseases, Macula Diseases, Visual Pathway Disorders, Vision Monitoring
- Medical subject headings
- Optic Nerve Diseases, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeCTesterDevice
Smartphone app that allows vision testing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: 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. Receives: Device: EyeCTester | |
| 4b. Cohort 2. FDA group | Patients in NOT practice Receives: 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. Receives: 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. Receives: 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. Receives: Device: EyeCTester |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Study was conducted for each patient in one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start9 Jan 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuro-Eye Diagnostic Systems, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neuro-Ophthalmology of Texas
- Responsible party
- Sponsor
- Investigators
- Rosa A Tang, MD, Principal investigator, Neuro-Ophthalmology of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607369
- Sponsor's protocol ID
- 20190049
- Status last verified
- Apr 2026
- First submitted
- 7 Oct 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: After FDA decision will send our results and statistical analysis to an appropriate journal for publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the NEDS EyeCTester App and NEDS Server Analysis Software Into the Homes of Patients With Neuro-ophthalmic, Retinal and Other Diseases to Enhance Early Detection of Active Eye Disease.
- ClinicalTrials.gov ID
- NCT04607369
- Acronym / sponsor ID
- 20190049
- Keywords
- Amsler Grid, Visual Field Defects, 10-2 Visual Field, Optic Nerve Diseases, Macula Diseases, Visual Pathway Disorders, Vision Monitoring
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neuro-Eye Diagnostic Systems, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Neuro-Ophthalmology of Texas
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Detailed Description of 4A and 4B: A series of patients with central visual defects were identified and their names were given to the unblinded clinical coordinator. The clinical coordinator contacted the patients, described the study, arranged the appointments to come to the clinic one-at-a-time for a dedicated visit to participate in the study. Each patient experienced the same study process for their visit:
- Met with the unblinded Clinical Coordinator who had the patient sign the informed consent after detailed explanation.
- Had the Clinical Coordinator put a number tag on the patient, and this was the number that the blinded participants of the study were to use for these subjects. Additionally, random numbers were used on the test forms.
- Patients met with blinded test trainer where the patient was provided standardized instruction for use of Amsler grid on-paper test, the Amsler grid on EyeQTester device, visual acuity and color sensitivity on paper and on the device. The instruction was enhanced between Cohort 1 and Cohort 2 as approved by the IRB for the different instruction protocol (see below discussion). Also, patients were given a test which they must pass in order to enter the trial.
- Patients then met with the blinded test administrator where the patient took the tests with no coaching. The test admin confirmed that the environmental parameters were similar across all patients over the course of the study.
- The patient completed test and re-test sequences.
- All test results with assigned random numbers were reported by the test administrator to the Clinical Coordinator who provided batches of blinded results to the Data Coordinator.
The investigators knew from prior clinic experience that the patients required a new and more detailed educational experience than was standard in order to have more reliable results for both the paper and app Amsler Grid test, in order to measure the central visual fields. The investigators focused on carefully training the patient through both written material and a video where the educational administrator was there to review this with the patient. The education focused on:
- What are "defects" and how to identify and report them.
- How to draw the above defects with attention to distance from the fixation point, size of the defect as well as its density.
Training enhancement was prompted midway through the trial, when the unblinded sponsor and clinical coordinator reviewed patient test results. Initial conclusion was that the patients exhibited defect identification on both paper and app that could possibly be enhanced by improving the educational protocol. An updated educational protocol was provided which the sponsor discussed with the educational team which was implemented to test if this updated patient education would result in more reliable results. It was decided to utilize updated educational approach for all patients on both paper and the app. Additionally, the investigators, added a stylus for the app (replacing the patient's finger) in order to more closely simulate a pen which is utilized for the paper. This updated approach was submitted and approved by the IRB.
As a result of the above, a decision was made to have two cohorts in the study, the early education cohort 1 and the later education cohort 2. Patients in cohort 1 were trained on the device to draw a defect on the screen with the tip of their finger but on paper to use a pen. Patients in cohort 2 were trained on the device to draw a defect on the screen with a stylus and on paper with a pen. The result in Cohort 2 was that consistency of the patients test results were better for both test and re-test for both the Amsler grid on-paper and the EyeCTester device.
The statistical analysis in this report shows the overall results and also the improved results in Cohort 2 that likely is attributed to these educational enhancement and stylus additions.
The full protocol for the trial including the training is available in the WIRB trial documentation.
Sample Size Calculation by our statistician was verified to be the sample size used was statistically acceptable.
Summary: Amsler app and paper version were equivalent, and best when using a stylus on the app.
Detailed Description of 7A and 7 B A series of patients 22 and over without any vision problems being examined similar to the above (see WIRB description) with a different education protocol consisting of in-home video on the app, telemedical connection by COA to confirm teaching was understood, and if not reteach.
The statistical analysis in this report shows the overall results showed that the vision testing standard and app were similar, with better vision tested on the app, by a formula that approximates, 7/10 of a line better.
The statistical analysis in this report shows the overall results showed that the color testing standard and app were similar.
The statistical analysis in this report shows the overall results showed that the Amsler grid testing via standard near vision tests and app were exactly the same with neither having false positives.
The full protocol for the trial including the training is available in the WIRB trial documentation.
Sample Size Calculation by our statistician was verified to be the sample size used was statistically acceptable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Groups in General all were done under the wcgIRB, even those that were Practice groups | – | Device: EyeCTesterGroups 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 |
| 1-3,5 Developmental team(1), Technician(2) and Non-Clinical Groups(3) 5. Retinal practice | – | Device: EyeCTesterIndividuals on the developmental team, staff members and outside clinic people 5 Retinal Practice (to do after FDA approval) |
| 4a. Cohort 1. FDA group | – | Device: EyeCTesterPatients in Neuro-Ophthalmology of Texas (NOT) PLLC practice which has referrals from multiple practices including retinal patients. |
| 4b. Cohort 2. FDA group | – | Device: EyeCTesterPatients in NOT practice |
| 6 At Home use of app in continuing clinical trial during FDA decision | – | Device: EyeCTesterPatients 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. |
| 7a Cohort 1 FDA group responding to AI | – | Device: EyeCTesterNormal 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. |
| 7b Cohort 2 FDA group responding to AI | – | Device: EyeCTesterNormal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For FDA approval Cohort 4a and 4b are the 2 groups being evaluated.
Key inclusion criteria (10 listed)
- The participant must have at least one eye which complies with all the 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.
Key exclusion criteria (23 listed)
- The participant must have at least one eye which complies with none of the exclusion criteria listed below.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyeCTesterSmartphone app that allows vision testing | Device | 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 |
Primary outcome
Primary Outcome Measure for Groups 4a and 4b:
Time frame: Study was conducted for each patient in one day.
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.
Secondary Outcome Measure for Groups 4a and 4b
Time frame: Study was conducted for each patient in one day.
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.
Primary Outcome Measure for Groups 7a and 7b
Time frame: Study was conducted for each patient in one day.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. After FDA decision will send our results and statistical analysis to an appropriate journal for publication
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Choroidal Melanoma, Indeterminate Lesions
RecruitingPhase 1/2
A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage
Glaucoma
Active, not recruitingPhase 2
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rosa A Tang, MD principal investigator
Neuro-Ophthalmology of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Nerve Disease and Macular Disease, run by Neuro-Eye Diagnostic Systems, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure for Groups 4a and 4b: (time frame: Study was conducted for each patient in one day.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.