Cataracts, presbyopia lens approved by FDA

January 15, 2009

The FDA last month approved a lens (AcrySof IQ ReSTOR +3 D, Alcon Laboratories) designed for implantation in patients with cataract and presbyopia.

Key Points

Charleston, SC-The FDA approval late last month of the AcrySof IQ ReSTOR +3 D lens (Alcon Laboratories) for implantation in patients with cataract and presbyopia will offer "patients a more comfortable reading distance, improved intermediate vision for tasks such as computer work, and excellent distance vision," said Kerry D. Solomon, MD, who was a study investigator.

Previously introduced in markets outside the United States, the new lens is based on the same platform as the study's control lens (AcrySof IQ ReSTOR +4 D, Alcon)-with the major difference between the two models being the strength of the add power, according to Dr. Solomon.

Use of 3 D of add power resulted in a shift in the optimal reading distance, which is now 2 to 4 inches farther away than with the lens that incorporates 4 D of add power, Dr. Solomon said.

The difference of 1 D in add power has some distinct advantages for patients and has filled a niche by refining vision for patients with different needs.

"This difference in the reading distance is more comfortable for patients," he said. "It also allows for intermediate vision that should be substantially better with this lens compared with the 4-D add power [lens]. The addition of the 3-D [add power] lens will provide more tools for physicians to tailor these lenses better to patients' lifestyles and needs."

Elderly patients who are more active, for example, may need predominantly intermediate vision, such as when working on a computer or light reading. For people who are less active, the 4-D add power lens is more suited for very fine vision such as knitting or doing a great deal of reading, he said.

The initial concern associated with the new lens design, Dr. Solomon said, was that the reduction in add power would contribute to night-vision symptoms of halos and glare.

"The trick was to reduce the add power and not cause an increase in night-vision symptoms, which was a risk in the design of the lens," he said. "The manufacturer, however, was able to make design changes to the rings, the number of rings, and the ring spacing that allowed for good night vision without those symptoms.

"Pre-clinical data suggested that the night vision would be no different or perhaps better than that achieved with the 4-D add [power] lens, and the clinical data bore that out," Dr. Solomon said.

Three hundred patients in the United States were included in the FDA trial; half of the patients received the 3-D add power lens and the other half received the 4-D add power design. Investigators found that night vision was better with the 3-D add power lens than that obtained with the 4-D add power lens. Most patients with the 3-D add power lens implanted had no or very mild halos, and no patients had moderate or severe night vision symptoms. The lens was very well tolerated.

Visual acuity results, as reported by the manufacturer, were very good. When investigators evaluated the near, intermediate, and distance visual acuities, they found that almost four times the number of patients had 20/20 vision at all three distances compared with those who had the 4-D add power lens.

Almost all patients in the study reported that they were highly satisfied with the results and would opt to have the lens implanted again.

"We do not have the ideal lens for every patient," Dr. Solomon said. "The addition of the 3-D [add power] lens will provide more patients with substantially improved intermediate vision."

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