FDA approves one-of-a-kind IOL with extended range of vision

It has been a history-making week for the ophthalmic world, and the FDA approval of the first IOL with extended range of vision (Tecnis Symfony IOL, Abbott) has only added one more reason for celebration.

The novel IOL is the only lens of its kind to be approved in the United States for providing continuous extended-depth-of-focus and visual acuity (VA) following cataract surgery, according to the company. The lens also reduces presbyopia effects by giving patients near vision, while having halos and glare incidence rates that are comparable to a monofocal IOL, the company reported.

The FDA approval also includes a toric version of the lens for patients with astigmatism.

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Numerous clinical studies including more than 2,000 eyes have explored the capabilities of the novel lens which has been approved in over 50 countries. The studies have shown that the lens provided continuous, sharp vision at near, intermediate, and distance, and at points in between.

“What makes it so special is that it is a much more forgiving lens,” said Eric D. Donnenfeld, MD, Ophthalmic Consultants of Long Island, New York, investigator for the clinical trial.

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Dr. Donnenfeld recalled a situation from the trial that he had not experienced in his career. After the cataract surgeries were performed on the control and treatment groups, the patients were placed into a single waiting room.

Soon after, one of the control patients realized she could not read at near distance. She became so upset, she insisted the monofocal lens be removed and that she be implanted with the extended-depth-of-focus IOL.

“It was the first time in my experience where a patient had a control lens and wanted the experimental lens,” Dr. Donnenfeld said. (After 90 days, the patient’s request was granted.)

“In 2016, patients don’t read as much as they used to at reading distances of 20 inches or so,” he said, adding that daily life today revolves around mid-range vision with cellphones and computer screens. “So it’s the perfect lens for someone who has a lifestyle that revolves around being about to see at mid-range…which is just about everybody.”

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Technology behind the design

Cataract trends

About 4 million cataract surgeries are performed every year, and the annual number is expected to grow in coming years. More than half of Americans have had a cataract by the age of 80. However, cataracts can also affect younger patients, as it is estimated that a quarter of all cataract surgeries will be on patients younger than 65.

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The IOL most surgeons use in cataract surgery is the monofocal IOL, which leaves the patient at a disadvantage for near or mid vision.

Technology behind the design

The innovation behind the extended depth-of-focus IOL is its unique pattern of light diffraction. If working on the principle of simultaneous vision, like a multifocal lens, one image would be in focus while the out-of-focus image is suppressed, which causes halos. Instead, the novel IOL has elongated focus.

Since the IOL is created with achromatic technology, it provides clear focus and eliminates blurry vision typical with chromatic or spherical aberrations.

Clinical study

The approval was based from a study which compared the novel IOL to a monofocal lens in 298 patients.

Patients who received the extended-depth-of-focus IOL had greater near and intermediate vision improvements while retaining distance vision. They also were more likely to achieve reduced overall spectacle wear and higher overall visual performance in various lighting environments.

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The treatment and monofocal groups had similar rates of adverse events.

Serious adverse events reported during the clinical study were unrelated to the IOL. They included retinal swelling, inflammation, and secondary surgeries.

Results

The randomized clinical trial involved 148 cataract patients implanted with the new IOL, while 151 were implanted with the monofocal IOL.

The study evaluated VA at near, intermediate, and far ranges, contrast sensitivity, and adverse events for 6 months after implantation.

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Of the patients implanted with the novel IOL, 77% had 20/25 vision, without glasses at intermediate distances, compared to 34% in the monofocal group.

For near distances, patients in the treatment group were able to read two additional, progressively smaller lines on a standard eye chart compared with the monofocal group.

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Both patient groups had comparable results for good distance vision.

The indication of the lens is for adult patients with less than 1.0 D of pre-existing corneal astigmatism who have had cataract surgery.

More to come

“The large amount of clinical data that we had before the US study was even completed…has been very consistent, demonstrating increased depth-of-focus...and low levels of visual symptoms,” said Tom Frinzi, senior vice president, Abbott Medical Optics.

The extended depth-of-focus IOL is expected to be available by September, but it may not be long before the company introduces another product to the ophthalmic community.

"One of the things that attracted me to AMO earlier this year was the robustness and richness of our pipeline. We have a lot of exciting products under development both on the cataract and refractive side,” he said. “We’re going to keep trying to have a steady cadence of new product introductions. As Frank Sinatra once said, 'The best is yet to come.'"

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