Doheny Image Reading Center

DIRC has developed a Part 11 compliant automated workflow system. The focus is to have all business aspects incorporated into this paperless automated system.

Features include:

• Web portal access for site users with:
  • Registration and account management
  • Site credentialing for photographer and system certification
  • Submission and uploading of images
  • Confirmation and notification of requests and uploads
  • Status and feedback communications within the web portal
  • Receive and resolve queries from DIRC
  • Clear visit schedule and required images for study participants
  • Built in logic checks and auto populated information for ease and convenience
  • Knowledgebase for user instructions and important information
• Web portal access for sponsor/CRA users with:
  • Registration and account management
  • Access to real-time information including:
    • General announcements
    • Visit submissions and statuses
    • Queries issued and pending for all request types
    • Site credentialing information
  • Report and Data download capabilities
  • Image download capability
  • Knowledgebase for user instructions and important information
• DIRC internal platform
  • Account management features with permissions
  • Ability to process a site submission from receipt to reporting in paperless system
  • Ability to move a case within the workgroups with change reasons and audit trails
  • Report features with real-time information including study data, KPIs
• Compliance
  • Validated, 21CFR Part 11 with applicable System Development Life Cycle Documentation

DIRC has validated a multi-grader process for manual analysis of non-contact (small-field) specular microscopy images, with very high intra- and inter-grader reproducibility. Accuracy and reproducibility of different manual grading methods (Center and Flex Center) have been validated separately. DIRC has been actively comparing these methods to each other and to automated and semi-automated alternatives under different conditions (see Research/Publications) in an effort to identify the most suitable method for minimizing the analysis time while ensuring accurate results for both normal and pathologic corneas. Parameters evaluated during the analysis (for either method) include cell density (CD), percent hexagonal cells (HEX), coefficient of cell size variation (CV), cell number used to derive the CD, presence and extent of guttae, image quality rating, and the relative standard deviation (RSD) between CD values. Our multi-step grading process, which relies entirely on masked certified graders, ensures minimal variation in most reported cases (RSD < 2.5%). The DIRC platform is currently optimized only for Konan imaging systems (all software versions), but efforts are already under way to convert images from other systems (e.g. Topcon, Tomey, HAI) for analysis (inquire here, if interested).

A validated, part 11-compliant, reading center planar image grading software that allows the grader to manually mark and label the boundaries of all structures of interest. The GRADOR program then quantifies the number of pixels for each structure and converts this to an area or linear measurement based on the instrument/image-specific pixel-mm conversion factor. GRADOR-derived measurements are used for all comparative analyses between image types.

A validated, part 11-compliant, image-grading software tool. Graders use a computer mouse to draw the boundaries of all structures of interest. With the OCTOR grading tool, we can access a considerable amount of potentially valuable quantitative information that had previously been unavailable. Using this computer-assisted grading software, our highly trained graders produce highly reproducible, quantitative sub-analyses, even in eyes with complex diseases such as non-exudative age-related macular degeneration and inherited retinal diseases.

A platform that supports multiple capture system devices, such as the Cirrus HD-OCT Macular Cube protocol, yielding the same results, regardless of the OCT capture system available and/or accessible at a clinical study site location.