Alcon, Inc. reported updated clinical results on the AcrySof®ReSTOR®intraocular lens (IOL) that demonstrate its ability to substantially restore a cataract patient’s ability to see both near and distant objects without the aid of reading glasses or bifocals. Today, the vast majority of patients who undergo cataract surgery receive monofocal IOLs, which typically require them to carry around reading glasses so they can read a newspaper, menu or medicine bottle, or do other things that require close vision such as sewing, building models and playing cards.
"These data are extremely promising, considering our nation’s dependence on reading glasses and bifocals to see near objects in general and especially following cataract surgery,” said James A. Davison, MD, FACS, of Marshalltown, IA,an investigator in the study,who presented Phase IIIstudy data at the American Society of Cataract and Refractive Surgery (ASCRS) annual symposium in San Diego. Dr. Davison added, “I believe the AcrySof®ReSTOR®lens will greatly improve quality of life for the vast majority of patients who receive it by eliminating or greatly reducing their dependence on reading glasses after surgery.”
The AcrySof®ReSTOR® IOL represents breakthrough technology because it delivers consistent high-quality pseudoaccommodative vision across the entire visual spectrum due to the unique, proprietary and innovative optics of the lens, rather than relying on unpredictable and variable mechanical processes to achieve accommodation. This lens achieved CE mark status April 4, 2003and is currently being implanted in patients outside the U.S.The Pre-market Approval application has been submitted to the FDA and Alcon anticipates this technology will be available in the U.S.in 2005.
“Based on the response by doctors and patients outside the U.S., we believe AcrySof®ReSTOR® will have a positive impact on our sales of IOLs,” said Cary Rayment, Senior Vice President, Alcon United States. “Reducing the need for reading glasses after lens removal, without compromising distance vision, has been a goal of ophthalmology for many years, and it looks like the range of accommodative effect and predictability of this lens may finally get us there.”
Study Methods and Results
Multi-center clinical studies were conducted in the United Statesand Europeto establish the safety and effectiveness of the AcrySof® ReSTOR®IOL. A total of 566 patients received the AcrySof® ReSTOR®IOL and 194 received the AcrySof®monofocal IOL as a control. The mean age for the total population was 69 years. In the study, 99 percent of patients who received the AcrySof®ReSTOR®and 98 percent of patients who received the monofocal IOL achieved distance visual acuity of 20/40 or better, without correction by contacts or glasses, with both groups exceeding the FDA grid value of 92 percent for this measurement. Furthermore, 88 percent of patients who received the AcrySof® ReSTOR®IOL
achieved distance visual acuity of 20/25 or better without correction by contacts or glasses compared to 92 percent for the monofocal control group, reflecting that the two lenses were statistically equivalent at this level of distance visual acuity.
As for near vision, following bilateral implantation (implantation in both eyes), 74 percent of patients receiving the AcrySof® ReSTOR®achieved near visual acuity of 20/25 (J1) or better without correction by contacts or glasses, while only 14 percent of the monofocal control group achieved this level. In addition, 85 percent of the AcrySof® ReSTOR®IOL patients achieved functional binocular uncorrected intermediate vision (20/40 or better (J3) measured at standard 60 cm computer screen working distance) compared to 67 percent of monofocal control patients. J1 means patients can read the very small stock quotes in the newspaper, while J3 means patients can read the normal newspaper type size.
This exceptional visual performance was independent of pupil size and was accomplished by the optics of the lens without physical movement of the lens inside the eye, making visual outcomes highly predictable. As a result, 80 percent of AcrySof® ReSTOR® patients reported never using glasses for either near or distance vision, compared to only 8 percent of the monofocal control patients. This is the first time this level of spectacle independence has been achieved.
Contrast sensitivity data presented at this meeting indicated that at lower spatial frequencies there was no clinically or functionally significant difference between AcrySof®ReSTOR®and monofocal control subjects. Other studies indicate that these lower spatial frequencies are most important in terms of vision related to everyday life skills, such as walking, driving, and reading.