- Testing sequences are programmed to eliminate technician deviation errors, bias, and Stopping Rule violations.
- System eliminates manual “paper” recording, including circling of letters, manual calculations, and errors in data upload.
- Distance calibration is adjustable to accommodate any test distance from 40 cm to 4 m.
- Computer-automated testing quickly and accurately guides technicians through test protocol for consistency, accuracy, and unbiased results.
- Optotype precisely calibrated for both distance to subject and pixels-per-inch, strictly following ANSI Z80.21, ISO 8596:2017, ISO 10938, ISO 17979 guidelines regarding size, spacing between optotypes, and spacing between lines.
- Monitor luminance is precisely calibrated utilizing a computer- integrated photometer following FDA guidance. Room luminance is measured and can be programmed to specific luminance conditions as required by the sponsor. Specific environment luminance levels can be programmed into the system which ensures consistency from site to site and visit to visit.
- Mesopic testing at 3 cd/m2 is available by utilizing a neutral density filter.
- Choose Sloan letters (10), British Standard Institution letters (12), Euro-wide letters (12), Tumbling E’s, Landolt C Rings, LEA Symbols®, LEA Numbers®
- Complete randomization of all optotypes, specifically following FDA guidance.
- Export test results automatically in an XML or CSV format to any EDC or Reading Center for immediate analysis.
FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.
