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    Address / contact

    Universitätsklinik für Augenheilkunde
    Inselspital
    Freiburgstrasse
    3010 Bern

    Collaborative research partners:

    Artificial Intelligence in Medical Imaging (ARTORG)

     

    FAQ

    What is an ophthalmology reading center?

    An ophthalmology reading center is an independent expert unit that evaluates and grades ophthalmic images acquired during clinical trials. These images may include optical coherence tomography (OCT), OCT angiography, color fundus photography, fluorescein angiography, fundus autofluorescence, and other retinal imaging modalities.

    The role of the reading center is to ensure standardized, masked, and reproducible assessment of imaging endpoints across all participating study sites. By applying predefined grading protocols and quality control procedures, the reading center provides consistent outcome measurements that support the scientific integrity of a clinical trial.

    Independence is essential to reduce bias and ensure objectivity. In multicenter clinical trials, investigators and study sites are directly involved in patient care and treatment allocation. Independent image grading separates endpoint evaluation from clinical management.

    Masked grading ensures that graders are unaware of treatment allocation and clinical details that could influence interpretation. This protects the credibility of imaging endpoints and strengthens the reliability of trial results.

    Independent assessment is particularly important in pivotal trials, where imaging findings may contribute directly to regulatory submissions and approval decisions.

    In multicenter trials, images are acquired at participating sites according to standardized imaging protocols. These images are transferred securely to the reading center via secure, proprietary data platform fully compliant with GDPR requirements, where they undergo quality control review to confirm adherence to protocol requirements.

    Experienced graders evaluate the scans using predefined grading manuals and validated software tools. Measurements such as retinal thickness, fluid presence, or morphological biomarkers are assessed in accordance with the study’s endpoint definitions.

    Quality assurance procedures — including double grading, adjudication processes, and inter-grader variability monitoring — are implemented to ensure consistency and reproducibility across all study visits and sites.

    BPRC operates within the framework of international regulatory and quality standards. These typically include:

    ICH Good Clinical Practice (ICH-GCP)
    Applicable FDA, EMA, or other national regulatory authority requirements
    Data protection regulations such as GDPR (for European studies)
    Study-specific protocol and sponsor requirements
    Quality management systems, documentation practices, grader certification processes, and audit readiness are essential components of regulatory compliance. BPRC is reviewed during sponsor audits or regulatory inspections ( ?) in the context of clinical trial oversight at regular intervals.