Digital System Certification

Each digital system to be used for a study must be certified. Imaging procedures specific to a study will determine what digital capture capabilities (color, FA, ICG, AF) are required.

  • All Digital Systems must be certified before any study subjects may be enrolled.
  • For each study you must submit a request for Digital System Certification.
  • If hardware or software changes occur during the life of the study, contact an FPRC Digital Imaging Specialist to inform them of the changes 608-410-0619.

Digital images may be taken using any of the following:

  • Sonomed Escalon (MRP OphthaVision®)
  • Merge Healthcare (OIS)
  • Topcon IMAGEnet®
  • Zeiss Visupac®, Visucam® NM-FA
  • Kowa VK2
  • Heidelberg® HRA, HRA2, Spectralis

Contact an FPRC Digital Imaging Specialist (608-262-1334) if you would like to certify a system that is not listed.

Topcon IMAGEnet® System

Certification Requirements:

Submit sample images (color, FA, or AF based on study-specific procedures) taken at 35 degrees and export as TIF or PNG files including the proofsheet images and the Datafile. The images should be centered on the posterior pole so that both the disc and macula are in view. Please see IMAGEnet® Study Drive set-up to set up Study Drive and IMAGEnet Export Procedure for instructions on export.

Sonomed Escalon (MRP OphthaVision®) System

Certification Requirements:

Submit sample images with the optic nerve head centered in the photograph. If a variable degree fundus camera is used, images should be taken at all magnifications. Contact Matt Carnevale at Escalon (800)-676-0043 for instructions. Once the images are analyzed by Escalon, the scale factor for that fundus camera will be sent to the study site. These factors will need to be entered into the preference files within the software. Once the system has been approved by Escalon, images should be submitted to the FPRC to verify image settings (color, FA, or AF based on study-specific procedures). Images can be exported as a "stacked" .tif file, individual .tif files, or .png files. See Escalon Digital Solutions (MRP) Export Procedure for instructions on exporting and submitting to FPRC.

Merge Healthcare (OIS) System

Certification Requirements:

Submit 10 images (color, FA, or AF based on study-specific procedures) of 10 different eyes at the acceptable angle (determined by camera type). The images must be centered on the posterior pole so that both the disc and macula are in view. If the center of the macula and the center of the disc are not clearly defined they cannot be used for calibration. Winstation® systems should have software version 10.0 or higher. Images should be exported as TIF or PNG ("No Loss TIF" -not lossless TIF). See OIS Export Procedure for instructions on exporting images correctly.

Zeiss Visupac System®

Certification Requirements:

Submit sample images (color, FA, or AF based on study-specific procedures) taken at 30 degrees and exported as DICOM (.dcm) files. The images can be anonymized manually prior to export (for certification and study submissions), or an "anonymizing" license may be purchased from Zeiss. See Visupac Export Procedure for instructions on exporting images.

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Heidelberg® HRA, HRA2, Spectralis System

Certification Requirements:

Images must be taken at the 30 degree setting. Submit a few sample images (FA, ICG, or AF based on study-specific procedures) exported in the .E2E file format. Eye Explorer® software must be version 1.3.5.0 or higher. See Heidelberg Export Procedure for instructions on exporting images.

Contact Info:

Kowa VK2

Certification Requirements:

Submit 10 images (color, FA, ICG, or AF based on study-specific procedures) of 10 different eyes at the acceptable angle (determined by camera type). The images must be centered on the posterior pole so that both the disc and macula are in view. If the center of the macula and the center of the disc are not clearly defined they cannot be used for calibration. Kowa systems must have VK2 softare. Images should be exported as uncompressed tiff files.

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