Tecnis Symfony IOL met its primary endpoint in pivotal trial for cataract- Abbott

Abbott has announced that its pivotal clinical trial of the company's Tecnis Symfony 1-Piece Acrylic Intraocular Lens (IOL) met its primary endpoint of improved intermediate vision. Data from this study showed that people who received the Tecnis Symfony lens achieved significantly improved intermediate, as well as near, vision compared to those who received a monofocal IOL. The clinical trial was a prospective, multicenter, bilateral, randomized, subject- and evaluator-masked clinical investigation conducted at 15 U.S. sites.

The study had two primary endpoints: uncorrected intermediate visual acuity (monocular UCIVA) in one eye, which is a measurement of how well the eye can focus at intermediate distances without the aid of glasses or contacts; and distance corrected intermediate visual acuity (monocular DCIVA) at 66 cm in one eye, which is a measurement of the best possible vision at 66 cm with the use of distance glasses or contacts. At 6 months of follow-up, patients in the Symfony group achieved 1.7 more lines of UCIVA and 2.4 additional lines of DCIVA at 66 cm than patients in the monofocal group. With and without correction for distance vision, Symfony IOL patients achieved an average binocular intermediate visual acuity of 20/20. People who received the Symfony lens gained 2.2 more lines of distance-corrected near visual acuity (DCNVA) compared with those in the monofocal group. People who received the Symfony lens achieved significantly better monocular near vision compared to those in the monofocal group. When testing both eyes together, mean visual acuity at near without correction was between 20/25 and 20/30. Rates of adverse events did not differ between the Symfony IOL and monofocal group. The data were presented at the American Society of Cataract and Refractive Surgery (ASCRS).