The Raindrop near vision inlay yielded significant improvements in near and intermediate visual acuity in patients with emmetropic presbyopia, according to a study.
The prospective FDA investigational device exemption clinical trial included 373 eyes from emmetropic presbyopic patients who were implanted with the Raindrop near vision inlay (ReVision Optics).
Out of the 373 eyes, 340 eyes underwent follow-up at 1 year.
Before implantation, 99% of eyes had uncorrected near visual acuity (UNVA) of 20/50 or worse, 53% of eyes had uncorrected intermediate visual acuity (UIVA) of 20/40 of better, and 99% of eyes had uncorrected distance visual acuity (UDVA) of 20/25 or better.
At 3 months to 1 year, 93% of eyes had UNVA of 20/50 or better, 97% of eyes had UIVA of 20/32 or better and 95% of eyes had UDVA of 20/40 or better.
Eyes showed a mean improvement of 5.1 lines in UNVA, a mean improvement of 2.5 lines in UIVA and a mean reduction of 1.2 lines in UDVA at 1 year.
Visual symptoms, which included glare, halos, double vision and vision fluctuation, were rated as either absent or mild in 95.9% of patients at the 1-year follow-up.
On a scale from 0 to 100, mean patient satisfaction was 56 before surgery. After surgery, mean patient satisfaction was 83, which was based on patients’ satisfaction without any correction.
“This improvement reflects the comparison of the subjects’ preoperative presbyopic correction with their postoperative presbyopic correction. After surgery, the correction is the result of the inlay alone and the subjects recorded their satisfaction without further visual assistance,” the researchers said. – by Nhu Te
Disclosure: The authors report financial interests with ReVision Optics.