Multifocal IOL is approved by FDA

The FDA approved a multifocal IOL (Tecnis, Advanced Medical Optics) for implantation in patients with cataract and presbyopia.

Key Points

Bloomington, MN-The FDA approved the Tecnis multifocal IOL (Advanced Medical Optics) for implantation in patients with cataract and presbyopia Jan. 16. This lens is designed to provide patients with high-quality near and distance vision under various lighting conditions. AMO reports that nine out of 10 patients are spectacle-independent after implantation.

"This difference in the size of the central zone became functionally relevant because in the clinical trial we saw that patients had a greater depth of focus through their intermediate zone," he said.

Unique surface

The lens also is not pupil-dependent.

"The IOL has a full posterior diffractive surface that makes vision pupil-independent," Dr. Chu said.

"Under different lighting conditions, such as when the pupil is small in bright sunlight or dilated in a dark restaurant, patients can still achieve the excellent 20/20 reading vision that they have in bright light," he said. "One of the disadvantages of other available diffractive lenses is that they are more pupil-dependent; patients might be able to read well when the pupils are smaller, but when the pupils dilate reading becomes more difficult."

Another noteworthy factor is that not all aspheric surfaces are the same, he said. The aspheric surface of the multifocal IOL is the same surface as in the monofocal model, which has been proven through FDA clinical trials to provide a superior quality of vision, Dr. Chu said. Based on FDA approval of the multifocal lens, he said, the options for surgeons have been simplified in his practice.

"The [new IOL] seems to be the best choice of a multifocal IOL for patients, because it gives them the best vision possible for reading with the fewest optical complaints," Dr. Chu said. "This lens will complement and augment the accommodating IOLs that already exist in our practice. I am excited about the approval of the . . . multifocal IOL because it will be an excellent addition to our armamentarium for patients with presbyopia."

AMO said it plans to begin shipment of the lens to U.S. ophthalmologists early this year.

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