Additional Relevant Details One- and three-year data from the trial were previously published in the peer-reviewed journal Ophthalmology. For the study, three types of visual function tests were performed using computer-run assessments: square localization (i.e. object detection), direction of motion (i.e. motion detection) and discrimination of oriented gratings (i.e. visual acuity). Two types of real-world orientation and mobility (O&M) tests were also performed: a test where patients were asked to locate and touch a door, and a test where patients were asked to follow a white line on the floor. The Functional Low-Vision Observer Rated Assessment (FLORA), a multi-part instrument that was developed specifically for use in patients implanted with a retinal prosthesis who suffer from profound loss of vision or blindness, was used to assess the functional visual abilities of patients and how they use the Argus II to complete a series of common activities of daily living. Before the development of the FLORA, there were no accepted, standardized assessments of functional vision or quality of life that could be used to assess the kind of vision that is restored by a retinal prosthesis. Common assessment tools of functional vision that are available such as the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) or the Massof Activity Inventory have only a few items that can be completed by those with ultra-low vision, with the majority of test items requiring higher levels of spatial vision (ability to read, recognize faces, identify colors).Earlier results from this trial were used to gain approval of the Argus II by the FDA in addition to CE Mark in Europe. The Argus II System is the first and only retinal implant to have both approvals. Although there are several research efforts in retinal prostheses worldwide, none has demonstrated the same level of reliability and efficacy as the Argus II did in a multi-centered, long-term, controlled clinical trial involving 30 subjects. Today over 180 patients have been treated with the Argus II.