EyeCTester App for Optic Nerve, Macular, and Visual Pathway Disorders
This study is looking at a smartphone app called EyeCTester, which allows for vision testing. It aims to see how well the app works for people with optic nerve disease, macular disease, or visual pathway disorders. Previous parts of this study (Groups 4a and 4b) showed that if you have an abnormal Amsler grid test on paper, you'll likely see a similar abnormality on the app. Another part (Groups 7a and 7b) found that people with normal vision don't get false positives on the app, and vision testing on the app is slightly better than with standard eye charts. This study is observational, meaning researchers are watching and collecting information without giving new treatments. Around 100 people aged 18 and older are planned to be included.
- Study design
- This is an observational study, meaning researchers are collecting information without giving new treatments. It involves a planned enrollment of 100 participants.
- What's involved
- Participants would come to the clinic for a single visit, sign an informed consent, and then take various vision tests on paper and using the EyeCTester app.
- Compensation
- Not stated in the trial record.
- Follow-up
- All primary and secondary outcome measures were conducted for each patient in one day, so there is no extended follow-up.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Implementation of the NEDS EyeCTester App
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rosa A Tang, MD · PRINCIPAL_INVESTIGATOR · Neuro-Ophthalmology of Texas
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Primary Outcome Measure for Groups 4a and 4b: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 4bStudy 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 7bStudy 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.