This article is more than 5 years old. Information may no longer be current.

IOL improves intermediate vision in US study

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

A prospective U.S. study showed marked improvement in intermediate vision after implantation of the AcrySof IQ ReSTOR^® IOL +3.0 D (Alcon Laboratories, Inc.).

Bret L. Fisher, MD, and Robert J. Cionni, MD, presented data from the U.S. study for Food and Drug Administration approval during the American Society of Cataract and Refractive Surgery annual meeting in San Francisco.

FDA data

Bret L. Fisher

Dr. Fisher explained that the new IQ ReSTOR^® IOL +3.0 D is much like the IQ ReSTOR^® IOL +4.0 D that many surgeons have already used but has demonstrated a marked improvement in intermediate vision.

“We are using the same platform, the same asphericity, the same energy distribution profile, same shape factor – all the positive attributes of the lens platform have been brought forward into the 3.0 add lens,” Dr. Fisher said.

The FDA study was a prospective, randomized, subject-masked, multicenter study.¹ Data were collected from 279 patients with bilateral implantation of either the IQ ReSTOR^® IOL +3.0 D or the IQ ReSTOR^®IOL +4.0 D.

“We were allowed to enroll patients with up to a diopter of astigmatism and we were not allowed to do anything about their pre-existing astigmatism,” Dr. Fisher explained.

Dr. Cionni said daily clinical practice has guided surgeons to decrease postoperative corneal astigmatism to 0.75 D or less.

“If we were allowed to enhance these patients that had some residual cylinder, treat them primarily at the time of their cataract surgery, with a limbal-relaxing incision, I think the numbers would be even better and that is what we are seeing postmarket now,” Dr. Cionni said.

There was no difference between uncorrected binocular photopic distance vision achieved with either lens implanted, with more than 60% of patients in both groups attaining 20/20 or better, approximately 88% to 89% attaining 20/25 or better, and more than 98% attaining 20/40.

“The one place where the 3.0 IOL shined particularly was improving the intermediate vision,” Dr. Fisher said, adding that there were statistically and clinically significant differences between the +3.0 D and the +4.0 D IOLs.

In addition, Drs. Fisher and Cionni agreed that reading vision was comparable between the two IOLs. Researchers found no difference in contrast sensitivity or visual disturbances between the two IOLs.

“The desire was to bring out a lens that would give patients better intermediate vision without compromising distance vision, near vision, or increased visual symptoms,” Dr. Cionni said.

Robert J. Cionni

Drs. Fisher and Cionni also presented data on the clinically derived binocular defocus curves for the IQ ReSTOR^® IOL +3.0 D and the IQ ReSTOR^®IOL +4.0 D. Patients reported good near vision on average at 15 inches and on average for 20 to 28 inches, which represent near reading through computer distance, a useful range of vision for patients (Figure 1).

“Patients had very high satisfaction and spectacle independence, which is what we are all looking for in our clinical practices,” Dr. Fisher said.

In response to a questionnaire that asked whether patients would have the same type of IOL implanted, about 95% of the IQ ReSTOR^® IOL +3.0 D patients said “absolutely,” Dr. Cionni reported.

“I do not think I have been involved in a study where the satisfaction rate is that high,” he said, adding that the percentage was extremely high for any study in which the patient pool was so limited.

Conclusions

The U.S. clinical study supports the impact of the IQ ReSTOR^® IOL +3.0 D on patients’ intermediate vision, and the physicians emphasized that the defocus curves are derived from actual patient measurements.

With the IQ ReSTOR^® IOL +4.0 D, about half of the patients could see far, near and intermediate at 20/32 or better, but with the +3.0 IOL, more than 86% of the patients are seeing at 20/40 or better at all three distances.

“Our patients now have all three distances,” Dr. Cionni said. “It gives your patients much greater freedom with their vision.”

References:

1. AcrySof IQ ReSTOR Posterior Chamber IOLs Clinical Study (Models SN6AD3 and SN6AD1).