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Washington, DC—The improvements in health-related quality of life (HRQOL) made with the AcrySof Natural IOL (Alcon Laboratories), an IOL that attenuates blue light, were not statistically different from the results achieved with the AcrySof single-piece conventional IOL (Alcon). The Natural IOL did not adversely affect night driving or other common lifestyle events that are measured by a HRQOL questionnaire, reported Paul Ernest, MD, at the American Society of Cataract and Refractive Surgery annual meeting.
The goal of the study conducted by Dr. Ernest and associates was to compare changes in patient-reported HRQOL following bilateral implantation of the AcrySof Natural (SN60AT) blue light-filtering IOL with the AcrySof single-piece (ultraviolet light [UV]-only) IOL.
The study was a prospective, randomized, parallel-groups trial in which patients underwent bilateral cataract extraction and implantation of the lenses. The study was carried out at six clinical sites in the United States. A total of 257 patients were included.
The patients were an average age of 72 years. The results of the Short Form-12 physical and mental component test were equal between the patients who received the AcrySof Natural IOL and those who received the AcrySof single-piece IOL.
Study inclusion criteria consisted of a minimum 20/40 VA postoperatively and the ability to pass the D-15 and Ishihara Color Test. Patients were excluded if they had ocular conditions, color deficiency, Alzheimer's disease, terminal cancer, or were taking any medications that were known or suspected of affecting color perception.
Patients agreed to complete the National Eye Institute Visual Functioning Questionnaire (VFQ-39). Assessments were conducted from baseline before the first eye underwent surgery, 30 to 60 days after surgery, and 120 to 180 days after the second eye underwent surgery. The overall VFQ provides a mean of all vision-specific VFQ-39 scales, excluding the general health area.
At baseline, Dr. Ernest explained, the equivalency of the study endpoint was defined as the third HRQOL assessment at 120 to 180 days after the second IOL implantation or early termination.
A total of 131 patients had the AcrySof Natural IOL implanted, and 126 had the AcrySof single-piece IOL implanted.
The results on the driving comparisons scale of the questionnaire, which represented improvements at 180 days after IOL implantation, showed that both IOLs provided patients with improvements in the areas measured: driving during the daytime, driving at night, and driving under difficult conditions, such as in bad weather and in heavy traffic.
"For all three individual driving items, significant improvements were observed for both IOLs (p < 0.0001 in all cases), and there were no significant differences between lens types (p= 0.8954 to p = 0.9834)," Dr. Ernest reported.
Another item about which the patients were questioned was the difficulty going down steps, stairs, or curbs in dim light or at night. As with the various driving situations, both IOLs produced similar improvements (p < 0.0001). The difference between the IOLs again was not significant (p = 0.2593).
The results of the findings are scheduled to be published in the Journal of Cataract and Refractive Surgery this year
"The AcrySof Natural IOL produced statistically significant gains in HRQOL comparable with those of the widely used AcrySof single-piece (UV-only) IOL. Importantly, the AcrySof Natural IOL does not adversely affect driving and other common lifestyle events as measured by the HRQOL," Dr. Ernest concluded.