May 08, 2016
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Extended range of vision IOL meets endpoint of improved intermediate vision

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NEW ORLEANS —The Tecnis Symfony extended range of vision IOL achieved the primary endpoint of improved intermediate vision in the Abbott sponsored pivotal clinical trial, according to one of the study investigators here.

The purpose of the study was to evaluate the safety and effectiveness of the Tecnis Symfony IOL model ZXR00, which is an investigational device in the U.S.

Jason J. Jones

The prospective, multicenter, bilateral, randomized, subject/evaluator-masked clinical investigation enrolled subjects in a 1:1 randomization to receive either the Symfony lens or a monofocal lens as control, in this case the Tecnis one-piece aspheric acrylic IOL ZCB00. Data on 147 subjects in the investigation arm and 148 subjects in the control arm were available at 6 months.

Topline data from Abbott regarding the study summarize that the “study showed the Tecnis Symfony IOL improved intermediate and near visual acuity compared to a standard monofocal lens, while maintaining comparable distance visual acuity.”

“In terms of distance acuities, both uncorrected and best corrected, monocular and binocular, this lens performs very similar to a monofocal and there was no difference statistically between the two,” study investigator Jason J. Jones, MD, said at the American Society of Cataract and Refractive Surgery meeting.

Regarding safety, at 6 months, there were no reports of IOL glistenings, and “general medical and lens findings/adverse events were comparable between both IOL groups,” according to the presentation.

Furthermore, 85% of subjects who received the investigational lens reported wearing glasses either none of the time or “a little of the time.” – by Patricia Nale, ELS

Reference:

Jones JJ. Visual outcomes of a new extended range of vision IOL. Presented at: American Society of Cataract and Refractive Surgery meeting; May 6-10, 2016; New Orleans.

Disclosure: Jones reports that he is a paid investigator in the Abbott sponsored clinical study. Abbott provided the data analysis and slide content for the presentation.