Key Takeaways
- Over two dozen industry professionals attended the WG-09: Ophthalmology meeting at AAO 2022
- The FDA has appointed a dedicated representative whose focus will be on DICOM standardization and compliance within the ophthalmic field
- OCT and OCT-A DICOM standardization need to be the foremost priorities in the near future
WHAT IS DICOM?
Digital Imaging and Communications in Medicine (DICOM®) is the international standard for medical images and related information. DICOM specifies the formats for medical images that can be exchanged with the data and quality necessary for clinical use. DICOM is implemented in many digital ophthalmic devices including Optical Coherence Tomography (OCT), OCT-Angiography (OCT-A), and Fundus Photography (FP). The DICOM Standards Committee established Working Groups (WGs) to develop the standard for specific modalities or clinical domains.
The WG-09: Ophthalmology group was established to address all issues relating to imaging and reporting of image-based studies in ophthalmic applications.
DICOM WORKING GROUP 9 ATTENDEES
Over two dozen industry professionals attended the WG-09: Ophthalmology meeting at American Academy of Ophthalmology (AAO) 2022. Representatives of the Department of Defense, Department of Veterans’ Affairs, National Eye Institute, Japanese Ophthalmic Instrument Association, and the FDA were present as well as doctors, professors, and representatives of AAO. Many equipment manufacturers were also in attendance along with imaging clinical trial service providers such as MERIT.
FDA RECOGNIZES IMPORTANCE OF STANDARDIZATION
The FDA has appointed a dedicated representative whose focus will be on DICOM standardization and compliance within the ophthalmic field. The FDA recognizes that this is an absolute necessity to advancing technology within the field of ophthalmic imaging.
PRIORITIES OF OCT AND OCT-A
There are numerous areas of DICOM standardization that have been laid out, but many of these are incomplete, or poorly defined. OCT and OCT-A DICOM standardization need to be the foremost priorities in the near future.
WG-09 recognizes the need to move forward and has tentatively planned for the next virtual meeting to be in January 2023, and in-person again at ARVO 2023, so that the group can get some momentum on the priority items and keep stakeholders engaged.
POSSIBLE CHALLENGES AND IMPORTANCE TO CLINICAL TRIALS
There will be challenges from manufacturers relating to implementation. MERIT was able to bring a unique perspective of using DICOM standardization relating to clinical trials, especially in the areas of anonymization of data and the different needs of file tags in comparison to routine clinical needs.
MERIT Ophthalmic Imaging Services
MERIT is an innovative, global clinical trial endpoint services provider. We partner with CROs, pharmaceutical, and biotech companies to deliver reliable endpoint services. Together our work advances and accelerates the improvement of therapeutic options for patients worldwide.
Partnerships with MERIT provide the following advantages:
- Expertise in managing and evaluating images
- Standardization of data, readers, and interpretation
- Technology platform for stakeholders to work together with data transparency and accessibility
- Collaborative approach with nimble and attentive service for Sponsors