DRIVE Study confirms zero-dilation EasyScan retinal camera

i-Optics reports partial top-line results from DRIVE, a head-to-head clinical trial comparing the performance of EasyScan to a traditional fundus camera, for the early diagnosis of Diabetic Retinopathy.

The results show that with the EasyScan scanning laser ophthalmoscope all 100 patients in DRIVE could be imaged successfully without requiring pharmacological dilation. Pupil dilation impacts practice throughput as administration can take up to 30 minutes per patient. Dilation also temporarily impacts patient’s independent mobility, but with the EasyScan zero-dilation retinal imaging technology, the patient’s vision remains unaffected.

One of EasyScan’s DRIVE endpoints confirms zero-dilation for 100 percent of the patients (n=100) included in the trial compared to 33 percent of patients requiring dilation for the traditional fundus camera (n=33). The majority of patients (56 percent) could be imaged in less than 3 minutes with a median of 174 seconds (50 percent range: 137-212 seconds). The DRIVE trial is the second completed study of EasyScan. i-Optics anticipates presenting detailed DRIVE study findings at a forthcoming medical meeting.

About the DRIVE Trial

DRIVE was randomized, rater-blinded comparator study that included 100 people with Diabetes, at the Eye Hospital Rotterdam, Rotterdam, The Netherlands. Trial participants were 18 years of age or older, 58 were female and 42 were male. Mean age (± standard deviation) was 60 ±11 years. All participating patients received retinal imaging with both the EasyScan confocal SLO system and conventional fundus camera and were first subject to retinal imaging using EasyScan. Endpoints include normalized sensitivity and specificity, referral rates for follow up exams and false positives and negatives, as well as percentage of gradable images for both instruments.