Artikel
Clinical Trial Results. Update from the Argus® II Retinal Prosthesis System (P2, I)
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Veröffentlicht: | 5. Mai 2014 |
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Purpose: The Argus II clinical trial is the largest trial of a retinal prosthesis in the world. Its subjects are constantly followed for safety and performance. There are 10 implanting centers involved in the clinical trial in the US, UK, France, and Switzerland. Before implantation, all 30 subjects enrolled (clinicaltrials.gov NCT00407602) were suffering from severe outer retinal degeneration that brought them to have bare light perception or worse in both eyes.
Methods: Safety is evaluated by recording the number, type, and severity of adverse events. Visual function is evaluated by high-contrast computer tests such as Square Localization, Direction of Motion, and Grating Visual Acuity. Functional Vision is evaluated with Orientation and Mobility tests and the Functional Low-vision Observer Rated Assessment (FLORA). In order to compare Argus II performance against subjects’ residual vision, all assessments are performed with the System ON and OFF.
Results: To date, this trial has gathered 160 subject-years of data. As of February 20, 2014, 25 subjects remain implanted with functioning Argus II implants. There have been three explants, two of which were elective, and two device failures (i.e., a failure to maintain communications link). On average, these 25 subjects have been implanted for 5.6 years (range of 4.5–6.7 years). The long-term safety profile remains very good; there was only one new non-serious adverse event (related to the device or the procedure) among all subjects in the last year. Performance on all assessments shows better function with the System ON than OFF, sustained beyond 5 years of use.
Conclusions: The Argus II Retinal Prosthesis System confirms in these latest results its long term safety and benefits as previously reported. The Argus II is commercially available in the US, Europe, and the Middle East.