GENERAL INFORMATION

A-ETDRS (​Automated ETDRS)

  • Utilized in multiple PMA studies in both IDE and IND studies
  • Peer reviewed and published by Southern College of Optometry, August 2015, submitted and approved for publication in “Optomtery & Visual Performance”
  • Can be used at Distance, Intermediate and Near testing distances and is fully customizable to accommodate non-standard calibration distances
  • Data can be automatically uploaded to any EDC or reading center from anywhere in the world (requires internet connection)
  • Tablet controlled for error free operation
  • Lifetime Technical Support - 24 Hour Technical Support for International Investigator Sites

FEATURES

  • Quickly and accurately measure visual acuity while eliminating technician bias and erroneous results
  • Choose Sloan letters (10), British Standard Institution letters (12), Euro-wide Letter Set, Landalt Rings or LEA Symbols
  • Each presentation is randomized thereby eliminating the memorization effect and is consistent and repeatable
  • System calibration set in meters at virtually any distance, and is adjustable and precise to within 1 cm
  • The system is calibrated for both distance-to-subject and pixels-per inch so that optotypes precisely follow ANSI Z80.21-2020 and ISO 8596:2017 in regard to size, spacing between optotypes, and spacing between lines
  • Background luminance is carefully calibrated to 85 cd/m2 for standardized ANSI and ISO testing or any other background luminance from 80 to 320 cd/m2, or as required for a study
  • System luminance can be automatically calibrated and ambient room conditions measured with the optional integrated luminance photometer
  • ETDRS results indicate ETDRS numerical score, visual acuity level and log value
  • Test results can be exported to any media file in any format for statistical analysis or automatically uploaded to any EDC or reading center

USE & OPERATION

  • The system is controlled by a high-resolution tablet via a standard Bluetooth connection utilizing our CustomLink® technology
  • The testing mechanism interfaces seamlessly with CTS (Clinical Trial Suite) to allow the technician to follow the protocol as determined by the sponsor
  • A descending ETDRS logMAR chart is presented using the Sloan letter set or any other available letter set
  • The subject responds with the smallest line where all five letters can be correctly identified and the technician simply enters the line number and presses “Submit”
  • The chart then randomizes, setting the selected line to the top line and a pointer is shown at the next smaller line
  • The subject is then asked to read this line and the number of correct letters is input; the pointer moves to the next line
  • The test continues until the subject is no longer able to correctly indentify any letters within a line
  • When the test is complete the results are reported in the standard ETDRS Letter Score, Visual Acuity equivalent and logMAR equivalent

HARDWARE OPTIONS

M&S Smart System® 20/20 USA All-in-One Computer

  • High-resolution 22” display
  • Designed and developed by M&S in Niles, IL
  • Manufactured in the USA (applies to SS-2020-USA)
  • Industrial grade componentry ensures longer product lifespan compared to computers built for the retail/consumer market
  • USA technical support based in-house at M&S in Niles, IL
  • One-year warranty

Touch-Screen Laptop

  • High-resolution 13” display
  • Lightweight and portable
  • USA technical support based in-house at M&S in Niles, IL
  • One-year warranty