Abstract
Abstract: :
Purpose: To determine the quality and reproducibility of OCT3 fast macular thickness scans in eyes with macular edema by using scans submitted for photographer certification in clinical trials. Methods: Clinic technicians applying for certification in clinical trials obtained duplicate OCT3 fast macular scans of 145 eyes (with various macular abnormalities) and sent them to a central reading center for evaluation of quality and reproducibility. Assessment of scan quality examined accuracy of scan centration, presence of all 6 underlying scan profiles, accuracy of automated detection of inner and outer retinal boundaries, and magnitude of center point standard deviation (< 10% of center point measurement). Duplicate scans were compared to determine reproducibility, particularly at the center point of the macula. Results: The initial scan was of adequate quality in 62.8% of the cases. Comparing duplicate scans assessed as good quality, the Pearson correlation coefficient for center point retinal thickness was 0.98, and the variance of the central point exceeded 10% of the thickness in 9.9% of the cases. From the initial scans, center point average thickness (SD) was 392 µm (+/–21). Conclusions: Strict criteria for OCT quality must be utilized in clinical trials to standardize data and improve reliability; highlighting the importance of the certification process to promote quality. When a scan is of good quality, the center point measurement of a repeat scan is unlikely to vary by more than 10%. This argues for requiring a second scan in such trials only if the first is deemed inadequate.
Keywords: imaging methods (CT, FA, ICG, MRI, OCT, RTA, SLO, ultrasound) • retina • clinical (human) or epidemiologic studies: systems/equipment/techniques