Abbott announced that the FDA has approved the »Tecnis Symfony IOL, the only lens in the United States that provides a full range of continuous vision following cataract surgery while also mitigating the effects of presbyopia, according to a company news release. The FDA approval includes a version of the lens for people with astigmatism, the Tecnis Symfony Toric IOL.
“The lens is different from a traditional multifocal IOL in that it doesn’t split light between near and distance focal points,” Jason Jones, MD, of the Jones Eye Clinic in Sioux City, Iowa, and a clinical investigator for the Tecnis Symfony IOL, said in an article submitted to Eyewiretoday.com. “Rather, a diffractive echelette design feature extends the range of vision, while achromatic technology reduces chromatic aberration to increase contrast sensitivity and enhance quality of vision.”
The approval was based on results of a US pivotal study that compared the Tecnis Symfony lens to a Tecnis aspheric monofocal lens in 298 patients. In the prospective, randomized, subject- and evaluator-masked study, 148 subjects were bilaterally implanted with the Symfony lens and 150 with the ZCB00 Tecnis monofocal lens. Mean age and gender was similar in both groups.
Monocular and binocular distance visual acuities for the Symfony subjects were clinically comparable to those of the monofocal control lens group. Monocular intermediate visual acuity with the Symfony lens was 1.7 lines (uncorrected) to 2.4 lines (distance-corrected) better than in the control group. Mean binocular uncorrected visual acuity at intermediate (66 cm) was 20/20 (0.002 LogMAR) at 6 months, and mean binocular uncorrected visual acuity at near (40 cm) was between 20/25 and 20/32 (0.146 LogMAR), according to data presented by Dr. Jones.
Patients in the Symfony group were also more likely to achieve reduced overall spectacle wear and high overall visual performance in any lighting condition. Rates of adverse events did not differ between the Symfony and monofocal groups.
“One of the things I’m excited about as a participant in the US clinical trials was the fact that we saw such a low incidence of glare and halos,” James Loden, MD, president of Loden Vision Centers, Nashville, Tennessee, said in an interview with Eyewiretoday.com. “In fact, in the US clinical trials, halos were reported as being severe in less than 2.8 percent of patients – really different than the 20 percent rate of halos that we see in some of the traditional diffractive optic lenses that we’ve used in the past.”
The Symfony lens is approved in more than 50 countries around the world, and has been widely studied, with data from numerous clinical studies involving over 2,000 eyes. According to AMO, in clinical studies the Symfony lens:
- Provided seamless, day-to-night vision. Patients could see objects sharply and clearly at near, intermediate and far away distances, and points in between.
- Provided high-quality vision. Some IOLs may leave patients with an inability to focus clearly due to competing wavelengths of light passing through the lens at different angles (known as chromatic aberration), or with vision that is not completely focused because of the shape of the lens (known as spherical aberration). The Symfony lens has been engineered to correct these issues.
- Demonstrated a low incidence of halo and glare, which may be perceived as rings or blurring around bright lights. Glare and halo can sometimes affect an individual’s ability to drive at night or to perform other visual tasks.
“Abbott is focused on improving people’s vision and their lives by helping them stay healthy and active. Symfony offers patients, including those with astigmatism, an option for crisp, clear vision at all distances,” Thomas Frinzi, senior vice president of Abbott’s vision business, said in the news release. “This is an important addition to our portfolio of lenses, as we expect many patients to choose a Symfony lens over a standard monofocal lens, given its benefits. We are happy that we can offer more people around the world this new category of lenses.”
The Tecnis Symfony IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity while maintaining comparable distance visual acuity. The Model ZXR00 IOL is intended for capsular bag placement only.
The Tecnis Symfony Toric IOLs, Models ZXT150, ZXT225, ZXT300 and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity while maintaining comparable distance visual acuity. The Model Series ZXT IOLs are intended for capsular bag placement only.