Within the last years, optical coherence tomography (OCT) has become a valuable asset in the neurologist’s toolbox to assess the progression of neurologic diseases. On the forefront, OCT is widely used in multiple sclerosis (MS) but its value is increasingly recognized also in other neurologic diseases like Alzheimer’s, Parkinson’s or different cerebellar ataxias.
In clinical trials, OCT is a biomarker for neurodegeneration and optic nerve inflammation. Our reading center provides specialized reading center services for multicenter trials in multiple sclerosis and other neurologic diseases such as OCT analysis, data management and center training.
Based on our scientific and clinical expertise, we guarantee state-of-the-art analysis in agreement with the latest scientific standards and with highest quality. We work according to the principles of Good Clinical Practice (ICH-GCP).
The reading center is located at the NeuroCure Clinical Research Center an ISO-9001 certified institution.
During the planning and preparation of a clinical trial we closely work together with principle investigators in designing the optimal OCT protocol for a trial’s purpose. In collaboration with device manufacturers, the protocols are then implemented on the centers’ devices.
To ensure highest possible imaging quality and comparability between different centers, in the beginning of a clinical trial, OCT operators are trained and have to pass certification scans.
During the trial, OCT images are sent to BORC using an easy web interface. They are then stored and processed further in a secure digital database inside the institute’s firewall. All data is processed without personal details in agreement with data safety standards in clinical research.
All OCT images are quality-rated within a short period of time and direct feedback is given to the centers. If a scan fails quality control, timely re-investigation of a subject is so possible. The quality rating is either performed internally directly at BORC or externally by a third, independent party.
A team of expert graders analyzes all OCT images that have passed quality control. Depending on the trial, we offer a set of common scan and analysis protocols as well as specialiazed protocols based on scientific methods developed in our laboratory (see below). The grading procedure is blinded and independent and therefore guarantees objectivity.
In coordination with the principal investigators, OCT analysis results are prepared and delivered for statistical analysis or monitoring.
Image Quality Control
We perform MRI and OCT image quality control according to the latest standards.