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New IOL offers greater spectacle independence
The AcrySof IQ ReSTOR® IOL +3.0 D (Alcon Laboratories, Inc.) and the IQ ReSTOR® IOL +4.0 D (Alcon Laboratories, Inc.) were shown to produce similar visual results for distance and near, with the IQ ReSTOR®IOL +3.0 D showing better intermediate vision. Findings from the clinical study were reported during sessions at the American Society of Cataract and Refractive Surgery 2009 meeting.
Richard Mackool, MD, and Robert J. Cionni, MD, emphasized that both IOLs give patients excellent visual results and spectacle independence. The prospective, randomized, multicenter study evaluated 279 subjects after implantation of either the IQ ReSTOR® IOL +3.0 D (n=138) or the IQ ReSTOR® IOL +4.0 D (n=131) in the second eye.
Dr. Mackool presented data on the FDA comparative study between the two IOLs. The researchers compared the IOLs in terms of patients’ distance, intermediate and near vision after implantation of the second eye. The researchers also studied patients’ range of vision and preferred reading distance, according to Dr. Mackool. Subjective data were also taken into account, such as how often patients wore glasses postoperatively and how satisfied they were with their IOLs.
The IQ ReSTOR® IOL +3.0 D and IQ ReSTOR®IOL +4.0 D were similar in terms of patients’ ability to achieve average uncorrected visual acuity of 20/20 or 20/25 or better near or distance vision. With best distance correction in place, approximately 75% of patients achieved near visual acuity of 20/25 or better with the IQ ReSTOR® IOL +3.0 D. If patients with best distance correction in place do not achieve 20/25, then Dr. Mackool searches for a problem that may be related to the surgical procedure or an underlying ocular pathology, rather than to the IOL.
If a patient does not see well with a ReSTOR® IOL, Dr. Mackool said, “I nearly always find a refractive error that somebody is not picking up, a corneal epithelial issue or macular edema.”
Visual range
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Adapted from data published in: AcrySof IQ ReSTOR Posterior Chamber IOLs Clinical Study (Models SN6AD3 and SN6AD1). |
The mean best reading distance was 37 cm (~15 inches) for the IQ ReSTOR® IOL +3.0 D and was 31 cm (~12 inches) for the IQ ReSTOR® IOL +4.0 D. When near vision was studied, the researchers found no major difference. Both IOLs provided excellent near vision.
The results for intermediate distance vision revealed significant improvement for patients who received the IQ ReSTOR® IOL +3.0 D compared to the IQ ReSTOR® IOL +4.0 D (Figure 1). Approximately 88.4% of patients who received the IQ ReSTOR® IOL +3.0 D had 20/32 or better uncorrected visual acuity at 20 inches (50 cm). At 24 inches (60 cm) and 28 inches (70 cm) 80.4% and 63.8% of patients, respectively, saw 20/32 or better with the IQ ReSTOR® IOL +3.0 D.
In contrast, 51.1% patients who received the IQ ReSTOR® IOL +4.0 D saw 20/32 or better at 20 inches. At 24 inches, 46.6% saw 20/32 or better and at 28 inches 38.9% saw 20/32 or better.
“So right away we see the most compelling and happily, desirable difference between these two lenses. Yes, you give up a teeny bit at near when you get within 1 foot or so, but what you gain in this intermediate range is astounding, seamless vision,” Dr. Mackool said.
Dr. Mackool also showed results from the defocus curves. At 20 inches, patients with the IQ ReSTOR® IOL +3.0 D have approximately 1.5 lines better visual acuity than patients with the IQ ReSTOR® IOL +4.0 D. Patients with the IQ ReSTOR®IOL +3.0 D demonstrated visual acuity of 20/25 or better up to nearly 28 inches, and even then the mean acuity was 20/32.
Spectacle independence
According to the FDA study results, the number of patients with spectacle independence is comparable between the two lenses. Although the IQ ReSTOR® IOL +3.0 D shows better intermediate vision than the IQ ReSTOR® IOL +4.0 D, that did not impact the number of patients with spectacle independence because it is unlikely that patients would carry spectacles for intermediate vision. Instead, they would simply move closer to the object they are trying to see, according to Dr. Mackool.
Patient satisfaction
When studying patient satisfaction, Dr. Mackool explained that the rest of the majority of patients who receive the IQ ReSTOR® IOL +4.0 D are happy and satisfied with their vision, whereas patients who receive the IQ ReSTOR® IOL +3.0 D are thrilled. The satisfaction survey in the FDA study showed that more than 95% of patients who received the IQ ReSTOR® IOL +3.0 D said that they would have the implant again, whereas 90% of patients who received the IQ ReSTOR® IOL +4.0 D would have it implanted again.
Visual disturbances
Dr. Cionni, medical director at the Eye Institute of Utah in Salt Lake City, reported that contrast sensitivity results were similar between patients who received either lens.
“Where we looked at sense of glare, halos, other visual disturbances [or] trouble driving at night,” Dr. Cionni said, “there wasn’t a statistically significant difference between the two groups.”