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The EyeCTester Model iOS is a mobile software as a medical device (SaMD) app for adults ages 22 and above. It is intended to serve as an aid to eyecare providers to monitor and detect central visual distortions (maculopathies) as well as central 10-degree visual field scotomas. EyeCTester is not intended to screen or diagnose, but it is intended to alert a healthcare provider of any changes in a patient's central visual status. The device is intended for both at-home and clinical use. The EyeCTester is indicated to be used only with compatible mobile devices.

The EyeCTester - Monitoring Application comprises a survey and a series of tests to provide remote monitoring of the patient's visual parameters from the patient's home. The EyeCTester -Monitoring application is available to patients with a prescription from the healthcare provider managing their vision. Prescribed, routine patient testing via the app allows providers to monitor vision health in the interim period between visits to the physician's clinical practice. The tool is not intended to replace the need for an in-person eye exam with a professional eve care provider. EyeCTester is not intended to diagnose the patient; diagnosis and management is the responsibility of the qualified team prescribing and interpreting the app measurements. Prior to regular, at-home use, patients will receive training in the clinic and will then undergo training within the app and verify their understanding of how to complete testing. Pop-ups will appear throughout the app reminding the patient that the app's purpose is to monitor changes in vision, not to provide a diagnosis. The app uses an Amsler Grid test to detect changes in visual distortions / scotomas / field cuts within the central 10 degrees of vision. The test prompts patients to outline and define distorted and/or missing areas on a series of grids while staring at a pulsating fixation point. At the end of the test, the grids are combined to display the patient's responses. The results of the assessments are summarized in a report that is provided to the prescribing healthcare provider to be interpreted and evaluated for any changes over time.