Longer-term outcomes now available: 6-month clinical trials of the AcrySof IQ ReSTOR IOL +3.0 D

“At intermediate
distances, the
+3.0 D group had
mean binocular
visual acuity of
better than 20/32
Snellen, which
was 1 to 2 lines
better than the
+4.0 D group
”
Bret L. Fisher , M.D.

Figure 1. Mean binocular defocus curves: binocular
vision of best-case patients at six months post-op


Figure 2. Overall spectacle wear: bilateral +3.0 D IOL patients, n=138, at six months post-op


Figure 3. Patient rating of vision

When the AcrySof IQ ReSTOR IOL +3.0 D (model SN6AD1, Alcon, Fort Worth, Texas) was approved by the U.S. FDA, the physician labeling presented three-month outcomes for patients in the clinical trials. The new package insert contains six-month data, comparing outcomes of patients with bilateral +3.0 D IOLs against outcomes of patients with bilateral +4.0 D IOLs (Alcon). Bret L. Fisher, M.D., Eye Center of North Florida, Panama City, Fla., who participated as an investigator in the clinical trials, discussed the new labeling.

Range of vision

According to Dr. Fisher, one of the most striking tests of the new IOL was the defocus curve, as shown in Figure 1. Both IOL models provided a full range of vision from near to distance. However, model SN6AD1 provided better intermediate vision, without sacrificing either near or distance vision. At ntermediate distances, the +3.0 D group had mean binocular visual acuity of better than 20/32 Snellen, which was 1 to 2 lines better than the +4.0 D group. Overall, the defocus curves indicated that the SN6AD1 IOLs delivered true performance at all distances.
Dr. Fisher said that the evidence from the defocus curve seems to be reflected in his patients’ lives. “In comparison to my patients with bilateral +4.0 D add IOLs, the patients with the +3.0 D add IOLs in both eyes are able to read more comfortably through a greater range, and most patients can even perform computer work comfortably without the need for glasses. They report good distance vision as they did with the +4.0 D lens, and they are able to read very fine print with ease.”

Spectacle independence

The increased range of quality vision produced a high level of spectacle freedom in patients with the +3.0 D IOLs, as shown in Figure 2. Results were similar for patients with the +4.0 D IOLs. Dr. Fisher said, “I am very pleased that the IQ ReSTOR +3.0 D add lens allows my patients to achieve the highest levels of spectacle independence of any premium lens that I have used.
In my patients, the rate of spectacle independence is greater than 90%,
which is higher than the percentage that we saw in the clinical trials.” He attributes his higher rates to correction of corneal astigmatism. “In the clinical trials, we were not allowed to correct astigmatism at the time of surgery or during the course of the study,” he said. “In actual clinical practice, most physicians who implant premium lenses now realize that we can get the best results for our patients if we are able to achieve 0.5 diopters or less of astigmatism.”

Image quality

At six months post-op in the clinical trials, all mean patient-reported visual disturbance ratings were in the none/mild category (less than 3 on a scale of 0 to 7) for both IOL groups. For visual disturbances like halos and glare, mean difficulty ratings at six months post-op were lower than at three months post-op (halos: 2.3 ± 2.2 at three months, then 1.9 ± 1.9 at six months; glare: 2.0 ± 2.1 at three months, then 1.6 ± 2.0 at six months). This decrease in difficulty may indicate some adaptation by the patients. The low mean ratings for visual
disturbances may be partly due to the apodized design of the AcrySof IQ ReSTOR IOL. The apodization of the diffractive rings means that the step heights are precisely reduced from center to periphery. At least one study has indicated that halos may be more severe with conventional diffractive lenses than with apodized diffractive lenses.
After considering these results, Dr. Fisher said, “I feel it is important to stress to my patients that there is no technology available today that will give them the vision of a 20-year-old, but the quality of vision with these lenses is excellent with minimal visual disturbances. I do educate my patients about the
technology and what they can expect from their vision and make sure their expectations are appropriate.”

Patient satisfaction

In the clinical trials, the average patient rating for quality of vision without glasses with the +3.0 D IOLs was 8.5 out of 10 (where 10 =“best possible vision”), which was similar to results with the +4.0 D IOLs. At last year’s European Society of Cataract and Refractive Surgeons (ESCRS) Congress in Barcelona, Dr. Fisher presented some patient-reported outcomes from the clinical trials. One of his slides is shown in Figure 3. Dr. Fisher’s experience in his clinic mirrors the results in the clinical trials. He said, “We have measured and reported the subjective and objective results of our patients’ experience with both the +4.0 D lens and with the +3.0 D lens. Patient satisfaction with the +3.0 D lens remains very high in our patients, equaling or exceeding what we saw in the clinical trials.”

Closing thoughts

Data from the clinical trials of the AcrySof IQ ReSTOR +3.0 D IOLs are now available for 138 bilateral patients at six months post-op. Dr. Fisher feels that the clinical trials indicate that “This lens has a much larger ‘sweet spot’ than previous multifocal implants. Because of the excellent performance of the +3.0 D IOL, I have been able to offer it with confidence to a much larger proportion of my patients. I am usually able to deliver the glasses free vision that my patients want from their cataract surgery.”

Contact information

Fisher: 850-784-3937; bfisher@eyecarenow.com

Reference

1. Chang DF . Prospective functional and clinical comparison of bilateral ReZoom and ReSTOR intraocular lenses in patients 70 years or younger. J Cataract Refract Surg 2008;34:934-41.