I participated as an investigator in a study sponsored by Alcon Laboratories, Inc. (Fort Worth, Texas), to evaluate the clinical performance of the aspheric AcrySof IQ Restor multifocal IOLs. Patients who desired near, intermediate, and distance vision with increased spectacle independence at all distances were deemed likely to benefit from these IOLs.
Preoperatively, patients had less than 1.00 D of corneal astigmatism, which made them good candidates for the IQ Restor lenses. Preoperative counseling was mandatory to ensure patients had realistic expectations regarding potential nighttime visual effects, such as perceptions of halos or radial lines around light sources.
The study, completed in December 2008, included 20 patients implanted with bilateral IQ Restor +3.0 D IOLs (model SN6AD1), the newest addition to the AcrySof Restor IOL family. Its thin optic design allows implantation through a small incision (1.8–2.2 mm) with the D Cartridge and Monarch III injector system (both by Alcon Laboratories, Inc.). Alcon analyzed the outcomes for these patients.
Patients returned for examinations at 1, 3, and 6 months postoperatively, with 16 patients (age range, 50–70 years) returning for the last visit. Results presented in this article include patients who reached the study's endpoint. With 10 patients aged in the 50s and four patients in their 60s, many were still active enough to have more visually demanding lifestyles than elderly patients. All patients had excellent distance UCVA at 6 months (equivalent to 20/25 Snellen or better [0.1 logMAR or less]). Near UCVA at 40 cm was also very good (average acuity, 0.14 ±0.05 logMAR).
Restor lenses provide good distance and near vision;1 however, the location of the near vision focus is different with the Restor +3.0 D and the +4.0 D models. The package insert states that the best location for near vision with the +4.0 D IOL (model SN6AD3) is approximately 33 cm from the eye; the best location for near vision with the +3.0 D IOL should be at approximately 40 cm from the eye.1 That agrees with observations in our surgical center. At 6 months postoperative, all patients chose a distance of 40 cm as their preferred reading distance. One patient chose a distance of 35 cm at 3 months postoperative, who did not return for the 6-month visit.
Another difference between the two models is the quality of intermediate vision. Because the near focus point of the +3.0 D is farther from the eye than with the +4.0 D IOL, the far and near points are now closer together, thus improving intermediate vision. In the US clinical trials, patients with bilateral +3.0 D IOLs had intermediate vision approximately 1 Snellen line better than patients with bilateral +4.0 D IOLs.1 Our patients were tested at 50, 60, and 70 cm, with a total of 11 patients (69%) achieving 20/32 vision or better (0.2 logMAR or less) at all distances. All patients achieved 20/40 UCVA or better (0.26 logMAR or less) at the intermediate distance. Figure 1 summarizes the average UCVA for patients at 6 months, with the chart placed at far, intermediate, and near distances.
After the visual examination, patients completed a questionnaire about satisfaction, spectacle use, visual disturbances, and visual lifestyle activities. At 6 months, all patients were satisfied with their vision. On a scale of 1 to 10, with 1 being completely dissatisfied and 10 being completely satisfied, no rating was lower than 8. All patients were spectacle independent, wearing no glasses for near, intermediate, or distance vision.
The questionnaire also included a section on visual disturbances, including halos and glare. To make sure the terms were understood, the questionnaire read, "glare/flare (trouble seeing street signs due to bright light or oncoming headlights)" and "halos (rings around lights)." The response rating scale was 0 for no difficulty, 1 for minimal difficulty, 2 or 3 for moderate difficulty, and 4 or 5 for severe difficulty. None of the patients rated halos or glare severe at any of the postop visits. All of the ratings for halos and glare were 0, 1, or 2 at all of the postop visits. At 6 months postop, 10 of the 16 patients (63%) rated the halos no difficulty, and the other five patients (38%) rated the halos minimal difficulty. For glare, five patients rated it no difficulty, 10 patients rated it minimal difficulty, and one patient rated it moderate difficulty.
Another section of the questionnaire asked patients about visual difficulties when performing various lifestyle activities without wearing glasses, including driving at night, using a computer, reading and near work, watching TV or movies, cooking, and using a cell phone. At 6 months postoperative, every patient responded with no difficulty for these items.
It is interesting to review patients' responses and how they changed at 1, 3, and 6 months, especially in regard to driving at night. At 1 month postoperative, five patients had not yet driven at night with their new IOLs; however, six patients had no difficulty and four had minimal difficulty. By 3 months, all patients had driven at night, with seven having no difficulty for night driving and eight patients having minimal difficulty. At 6 months postop, all patients said they could drive at night with no visual difficulty. With time, patients gained confidence with their new lenses.
Restor +3.0 D IOLs provided patients with good vision at far, intermediate, and near distances. Patient satisfaction was high, spectacle independence reached 100%, and all patients were able to perform their daily activities without visual difficulty.
José Luis Rincón, MD, is the Director of the Anterior Segment Department, Instituto Oftalmológico IUMO, Caracas, Venezuela. Dr. Rincón states that he has no financial interest in the products or companies mentioned. He acknowledged editorial assistance from Alcon in preparing this article. He may be reached at tel: +58 212 903 48 11; fax: +58 212 903 48 17; e-mail: firstname.lastname@example.org.
- Alcon Laboratories, Inc. AcrySof IQ Restor physician labeling. 2009: Fort Worth, Texas.