United States Food and Drug Administration (FDA) just approved the first ever multifocal intraocular lens (IOL) that will help cataract patients to see better at near, moderate, and long distances.
This new approved product, the Tecnis Symfony intraocular lens (IOL), from Abbott Medical Optics will help provide patients with “extended depth of focus”. The new lens will also help reduce the need of wearing spectacles and contact lenses for near and moderate distances.
This is welcome news for many citizens of United States suffering from the condition currently. According to the National Eye Institute, chances of cataract increase in each decade of life, right after a person turns 40. At the age of 80, 70% percent white Americans will have cataract while 53% percent of blacks and 61% percent of the Hispanics have the same condition at the same age.
Nearly 4 million corrective surgeries are performed every year in United States due to this condition. Estimations predict that by the year 2050 the number of people in US suffering from cataract will reach to 50 million from 24.4 million.
This type of IOL is implanted into the eye, after cataract along with the natural cloudy lens, is removed from the patient’s eye during surgery. Previously, other kind of IOLs available did help patients to improve their long distance sight but without little improvement in the near or moderate distance vision.
Approval for the product came after an FDA review of the trial conducted by the manufacturing company. A randomized control trial of 148 cataract patients was conducted in which they were given the Tecnis Symfony IOL. The results were compared to 151 patients fitted with monofocal IOL. Both groups had good distance vision; however, 77 percent of the patients fitted with Tecnis Symfony IOL had good moderate distance vision compared to 34 percent with monofocal IOL.
The lead investigator of the trial, Eric Donnenfeld, MD, from New York, explained that the results of the Symfony trial were so good that after it was over, the patients were waiting in single room and one of the women fitted with monofocal IOL could not see properly and became quite upset. She insisted that she must be implanted with the new lens at once. She was granted her wish after 90 days.
Donnenfeld remembered the incident as this was the first time in his career that a patient in the control group insisted on receiving the experimental lens.
The Director of the Division of Ophthalmic and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health, Dr Malvina Eydelman, agreed with the FDA’s assessment too and expressed that the lens will indeed help many people see better.
The new lens can cause worsening or blurriness of vision, bleeding and infection in some cases. Other possible side effects can be reduced contrast sensitivity which can become poor under low light conditions, visual halos, glare and star bursts. It was also made clear that this product should not be used in patients who have suffered previous eye trauma.
Often people suffering from cataracts in their eyes can also experience other problems like presbyopia and astigmantism. The lens also addresses these issues.
Astigmantism is a condition where cornea of the eye is not in its proper shape causing blurry or distorted vision. Presbyopia is where people have lost the ability to focus on objects and require wearing prescribed glasses to perform vision orientated tasks. This condition is mostly seen in patients over the age of 40.
Symfony lens has been approved in more than 50 countries around the world and is available in 4 toric models which help with both of these conditions.
“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,” Senior Vice President of Abbott’s Vision Business said after the news of the approval.
Abbott laboratories in the state of Illinois is an American Healthcare company with annual revenue of 20.2 billion in the year 2014. The company is currently in the top 250 public companies of the world, according to Forbes, with a market capital of $ 64.9 billion.