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Surgeon: Allegretto Wave laser yields good results
Patients treated with the Allegretto Wave laser experienced an overall improvement in nighttime visual function, surgeon says.
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PARADISE VALLEY, U.S.A. — The Lumenis Allegretto Wave excimer laser provided good results in clinical trials for U.S. regulatory approval.
“The Allegretto Wave laser is a flying-spot, 200 Hz, Gaussian-shaped 0.95-mm laser that works using ablation profiles that minimize spherical aberration postoperatively in the average eye,” said Guy M. Kezirian, MD, FACS, an investigator in the clinical trial. “The refractive and visual results are very good, plus there’s been overall improvement in nighttime visual function and night driving in the study.”
Dr. Kezirian reviewed the results of the U.S. Food and Drug Administration clinical trials in a presentation at the European Society of Cataract and Refractive Surgeons meeting.
“The results have been extremely good. We have 67% of the eyes with corrections of up to –7 D at 20/16 or better and 25% at 20/12.5 or better,” he said.
Study results
The trial, which involved 11 sites and 11 surgeons, showed that the Allegretto Wave laser offered comparable treatments to those offered by wavefront-guided ablation systems.
“There are two important lessons from the series,” Dr. Kezirian said. “First, performing LASIK with the latest technology delivers excellent visual refractive results that will probably not be exceeded by routine custom wavefront. The second lesson is that in cases where glare and nighttime driving problems exist after LASIK, treatment of residual refractive errors will likely correct the problem. There was no relationship found in this series between pupil size and nighttime visual complaints when the refractive result was good.”
According to Dr. Kezirian, glare and halo in nighttime driving are common complaints after LASIK, something he hopes the Allegretto Wave laser will prevent.
“The ablation profiles have been adjusted to prevent induction of spherical aberration,” he said. “The biggest problem we’ve had with LASIK in the public eye at this point is that nighttime visual function does not necessarily perform as well after LASIK as it did before. This laser has addressed that in a couple different ways. It’s adjusted to prevent induction of spherical aberration, and it treats with a larger optical zone. When you’re using an optical zone that is 6.5 mm with this laser, the entire 6.5 mm is the optical zone. So by preservation of the optical zone and by better shaping of the ablation profile, nighttime visual function has been shown to improve in the study.”
The average eye
According to Dr. Kezirian, the Allegretto Wave laser performs better in the average eye than standard wavefront technology.
“We found an average eye will do as well with standard LASIK from this laser as it will with a custom wavefront treatment,” he said. “The laser minimizes the induction of aberration in the standard, average eye. If someone has pre-existing higher order-aberrations, a lot of coma, then we believe the custom wavefront would be better. At this point, it appears in average eyes, standard treatments with this laser will do as well.”
As part of the study, Dr. Kezirian said he studied the results from other excimer laser trials to see how well the Allegretto Wave performed in comparison.
“I did a review of the published U.S. FDA results from other excimer laser trials from the past, and I conducted some of those excimer laser trials myself, and the results from this laser are far superior to anything that’s been reported before for pretty much all parameters,” he said. “Uncorrected acuity results and refractive results have been significantly better. On the safety side, safety is as good as or better than anything reported in a U.S. FDA trial.”
According to Dr. Kezirian, the results of the Allegretto Wave laser are so strong, he believes it will make a large impact in the use of excimer lasers in LASIK.
“The current efforts that have been advancing refractive technology today seem to mainly focus on using custom wavefront LASIK to treat refractive errors,” he said. “The results we reported using regular LASIK with this laser are as good as any series using custom wavefront treatment that I’ve seen. I believe it’s going to be difficult for our existing technologies to exceed what we’ve seen with this laser, even with custom wavefront.
“That doesn’t mean custom wavefront has no role. I think it does. I think it has a role where there are significant pre-existing higher-order aberrations. I think it has a very important role in reoperations, when a patient has a result that’s not satisfactory. But as far as primary treatments, I don’t think custom wavefront is going to be the treatment of choice in most primary treatments.”
For Your Information:
- Guy M. Kezirian, MD, FACS, can be reached at SurgiVision Consultants, 4601 East Mockingbird Lane, Paradise Valley, AZ 85253; (480) 348-9299; fax: (480) 348-9288; e-mail: Guy1000@SurgiVision.biz. Dr. Kezirian is a partner in SurgiVision Refractive Consultants, LLC, which runs the United States regulatory (FDA) trials for the WaveLight Allegretto excimer laser system.
- Lumenis, distributor of the Allegretto Wave excimer laser, can be reached at 2400 Condensa St., Santa Clara, CA 95051; (408) 764-3000; fax: (408) 764-3660.