FDA approves intraocular lens

FDA approves intraocular lens with extended depth of focus for cataract patients

Near, immediate and far distances. That's what the U.S. Food and Drug Administration's (FDA's) recent approval of the first intraocular lens (IOL) with extended depth of focus means for patients with cataracts.

“Now doctors and patients will have more options available to allow them to maximize their visual potential.”

And it provides just one more option for doctors of optometry when they are advising their patients.

The FDA approved the Tecnis Symfony Extended Range of Vision IOL on July 15.

"While IOLs have been the mainstay of cataract treatment for many years, we continue to see advances in the technology," says Malvina Eydelman, M.D., director of the Division of Ophthalmic and Ear, Nose and Throat Devices in the FDA's Center for Devices and Radiological Health.

"The Tecnis Symfony Extended Range of Vision IOL provides a new option for patients that may result in better vision across a broader range of distances," Dr. Eydelman says.

The FDA's approval of the extended depth of focus IOL resulted from a clinical trial comparing the outcomes of cataract patients (148) implanted with the new, extended-range IOLs versus patients (151) fitted with a monofocal IOL. Participants' visual acuity was measured at near, intermediate and far distances; for contrast sensitivity; and post-implants complications. During cataract surgery, the clouded lens in the eye is replaced by an IOL.

"Of the patients implanted with the Tecnis Symfony IOL, 77 percent had good vision (20/25), without glasses at intermediate distances, compared to 34 percent of those with the monofocal IOL," the FDA reported.

"For near distances, patients with the Tecnis Symfony IOL were able to read two additional, progressively smaller lines on a standard eye chart than those with the monofocal IOL," the federal agency says. "Both sets of patients had comparable results for good distance vision."

About 20 percent of Americans will suffer from cataracts by the age of 65, according to the National Eye Institute.

Another option for doctors of optometry and patients

"Although this is not the first intraocular lens that can provide clear vision at multiple distances to be approved by the FDA, it is the first to provide clear vision at various distances through an extended depth of focus," says Jeffrey J. Walline, O.D., Ph.D. Dr. Walline is the associate dean for research at The Ohio State University College of Optometry and immediate past chair of the AOA's Contact Lens & Cornea Section.

"Now doctors and patients will have more options available to allow them to maximize their visual potential," Dr. Walline says. "According to study results, this lens provides similar distance vision as a single-vision intraocular lens, but improved intermediate and near vision. However, there may be some decrement in vision compared to single-vision intraocular lenses, especially in dim situations."

Dr. Walline also took note of the 2015 FDA approval of another IOL that allows cataract patients to see at all distances. "In other words, it does the same thing as the AcrySof IQ ReSTOR Toric Multifocal IOL, but it does it in a different manner," Dr. Walline says.

"Both lenses allow patients who previously had cataracts to see clearly at various distances," he adds. "So, it is not the first lens to do this. It is just the first lens to do this with extended depth of focus."

July 25, 2016

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