Clinical experience with AcrySof ReSTOR lens in cataract patients

October 1, 2005

Approved by the FDA in March 2005 for use in cataract patients with or without presbyopia, Alcon's AcrySof ReSTOR lens is the first apodized diffractive intraocular lens (IOL) to be made available. The approval was granted based on clinical trials which found that patients experienced the highest level of freedom from glasses ever achieved in IOL clinical trials.

Rudy Nuijts, MD, Associate Professor at The Academic Hospital, Maastricht, The Netherlands spoke of his experience with the AcrySof ReSTOR lens at the XXII Congress of the European Society of Cataract and Refractive Surgery in 2004, Paris.

I would like to share my clinical experience with the AcrySof ReSTOR intraocular lens (IOL) in patients with cataract. We performed a prospective study of 63 eyes of 32 patients (31 bilateral and 1 unilateral). All surgeries were performed by one of two surgeons, and second eyes were operated on within two weeks of the first eye. The inclusion criteria were senile cataract with corneal astigmatism less than 1.5 diopter (D) and IOL power between 16 and 25.5 D; ocular comorbidity was excluded. Based on these criteria, about 56% of our cataract patients were eligible. Our outcome measures were both refractive status and quality-of-life issues.

At six months after surgery, the mean spherical equivalent at distance was 0.06 D. Overall, 90% of eyes were within ±0.5 D of target refraction, and 100% of them were within ±0.75 D. Postoperative monocular uncorrected Snellen distance visual acuity was 0.7 and increased to 0.9 with correction. Binocularly, uncorrected acuity was 0.9 and increased to 1.0 with correction.

At first glance, these lenses would seem to be quite equivalent in terms of outcomes. Comparing refractive outcomes with the Array versus the AcrySof ReSTOR lens, the mean spherical equivalent postoperatively was approximately the same for both patient groups, and the mean refractive astigmatism after surgery was also the same. The monocular distance visual acuity outcomes for the AcrySof ReSTOR and the Array lenses in the uncorrected and best-corrected groups were similar.

But the near acuity was the big difference. The AcrySof ReSTOR lens provided a 2-line better uncorrected near acuity than the Array lens. This had an important quality-of-life correlation: 85% of our AcrySof ReSTOR patients never used glasses for near vision compared with only 14% with the Array lens.

Objective measurements, such as acuity and refractive status, are important, but subjective quality of vision issues also impact patient satisfaction with their surgical outcomes. If we compare our results with the AcrySof ReSTOR lens to the published results with the Array lens, we find that patients have fewer subjective visual complaints with the AcrySof ReSTOR lens. The contrast sensitivity (as measured with the vector vision chart) was statistically comparable between the 2 groups.

Patients in both groups were asked to rate their satisfaction with their vision on a scale of 1 to 5, with 5 representing most satisfied. Patients who received the AcrySof ReSTOR lens reported much higher satisfaction ratings than patients who received the Array lens. There was a difference between the Array and the AcrySof ReSTOR lenses for the quality of near vision without glasses - 4.0 for the AcrySof ReSTOR IOL versus 2.9 for the Array. To conclude, I believe that the AcrySof ReSTOR lens provides excellent near visual acuity without compromising distance visual acuity. Mean uncorrected visual acuity at distance and near were excellent, patients were generally free of spectacles for near work, and most patients were highly satisfied with their postoperative vision. Such outcomes make the AcrySof ReSTOR lens a desirable addition to my practice.