FDA Approves Tecnis Toric Intraocular Lens

Ricki Lewis, PhD

April 18, 2013

The US Food and Drug Administration (FDA) has just approved Abbott's Tecnis Toric 1-piece intraocular lens (IOL) to treat preexisting astigmatism in patients with cataract.

The blurry vision of corneal astigmatism derives from an irregularly curved cornea that prevents light rays from focusing sharply on the retina. Toric intraocular lenses are used to manage corneal astigmatism in patients who have undergone cataract surgery and who have had their natural lenses removed.

More than 3.5 million cataract surgeries are performed in the United States each year, with an average patient age of 68 years. The number of cataract surgeries is expected to grow by about 4% annually, generating a large market of patients seeking improved vision without wearing glasses. About 20% of patients with cataract have significant preexisting astigmatism.

The Tecnis Toric 1-Piece IOL is different from IOLs already on the market in that it can correct loss of focus of 1 diopter or greater. Clinical trial results indicate that the device offers exceptional rotational stability while improving visual results. It also sharpens distance vision by minimizing imprecise light focusing (spherical aberration).

The new device also improves night vision. Clinical trial participants took part in a simulated night-driving study that found that the lenses added 45 feet of distance vision when driving at 55 miles per hour and added 1 second of reaction time compared with a competitor's device.

The new IOL uses a proprietary surface treatment and is exceptionally thin, making it easier to unfold and implant, according to company literature.

An alternative to toric intraocular lenses is limbal relaxing incisions. A survey published in the Review of Ophthalmology of 43 ophthalmologists found that 57% preferred toric IOLs to help patients with cataract who have preexisting astigmatism, and 31% preferred limbal relaxing incisions. The physicians preferring the toric intraocular lenses cited greater predictability of function and stability, whereas those preferring limbal relaxing incisions mentioned the ease of the technique and its lower cost.

"The Tecnis Toric IOL decreases astigmatism while improving visual quality, with improved functional vision. Having implanted several Tecnis Toric IOLs within clinical trials, I find it delivers excellent patient results," said Kevin Waltz, OD, MD, from the Eye Surgeons of Indiana and a clinical investigator for the lens, in a news release. Information for patients is available on the manufacturer Web site.