Subsample analysis results
The subsample analysis—the goal of which was to evaluate the 12-month safety and effectiveness of the device for improving DCNVA in patients with presbyopia (the primary endpoint)—included 20 eyes of 10 consecutive patients (7 men, 3 women). They were a sample of 68 patients who underwent implantation of the device at the surgical site.
These 10 patients, according to Dr. Chu, were early surgical subjects from the Chu Vision Institute, an IDE clinical research site.
The mean age of the patients at surgery was 53.3 years (range, 46 to 57 years). The mean MRSE was +0.181 D (range, -0.25 to +0.50 D). The baseline monocular average DCNVA was 20/64.2 (range, 20/50 to 20/80) and the binocular average was 20/51.6 (range, 20/25 to 20/80).
Nineteen of the 20 eyes completed the final evaluation at 12 months.
At that time point, Dr. Chu noted, all patients achieved DCNVA of 20/40 (J3) or better, and 85% achieved DCNVA of 20/32 (J2) or better. Regarding UCNVA, all patients achieved 20/40 (J3) or better and 90% achieved UCNVA 20/32 (J1) or better.
Interestingly, the investigators observed a decrease in the mean near-add requirement of 1.02 D, down from 1.49 D at baseline to 0.47 D at the final evaluation.
“Almost all patients gained at least 2 lines of DCNVA,” Dr. Chu said. “The near visual improvements appeared to increase over time. The patients were highly satisfied with the procedure and the results.”
He added that this subsample evaluation of patients at a single center participating in a multi-center clinical trial suggested that the implant system might provide near-vision correction with a corresponding reduction in the amount of refractive add needed to achieve an optimal DCNVA.