Custom wavefront-guided LASIK nets visual gains in hyperopia treatment

All eyes had BCVA of 20/40 or better, and 96% of eyes were within 1 D of desired refraction at 1 year, investigator says.

ByErin L. Boyle

An emerging custom wavefront-guided hyperopic LASIK treatment yielded favorable visual outcomes in a clinical trial, one investigator reported.

At the American Society of Cataract and Refractive Surgery meeting, OSN U.S. Edition Refractive Surgery Section Member Stephen G. Slade, MD, presented 1-year results for hyperopic LASIK performed with the Zyoptix Personalized Laser Vision Correction System (Bausch & Lomb) in conjunction with Bausch & Lomb’s Technolas 217z excimer laser.

“This was essentially a safety and efficacy trial for hoped approval of the treatment of hyperopia with wavefront LASIK,” Dr. Slade said.

The procedure was successful, and the results are ready for submission to the U.S. Food and Drug Administration, he said.

The Zywave aberrometer software measures up to 6 D of hyperopia and up to 5 D of astigmatism.

The integrated Zyoptix system used in the trial also included a Shack-Hartmann wavefront aberrometer and Bausch & Lomb’s Orbscan topographer, Dr. Slade said.

The four-site, 2-year, prospective bilateral clinical trial comprised 159 eyes of 80 patients. The treatment range was up to +4 D of sphere and +4 D of cylinder, he said.

Visual acuity, safety, predictability

Before surgery, fewer than 40% of eyes had uncorrected visual acuity of 20/40. However, 99.36% of eyes saw 20/40 or better 12 months after surgery. Seventy percent of eyes saw 20/20 or better and 33% of eyes saw 20/16 or better, also at 12 months, Dr. Slade said.

“There were very nice improvements in uncorrected visual acuity from preop to 12 months,” he said.

Stephen G. Slade

The data also showed favorable results for best corrected visual acuity; 100% of eyes saw 20/40 or better, 99% of eyes saw 20/20 or better and 64% of eyes saw 20/16 or better, Dr. Slade said.

Contrary to expectations, more eyes gained lines than lost lines of visual acuity, he noted.

“As far as safety, we did have more eyes that gained a line of best corrected visual acuity than lost a line,” he said. “Of course, in a hyperopic trial, you would expect the reverse than you see in a myopic trial. We didn’t necessarily expect to, but we did gain lines.”

The data showed a reduction in higher-order aberrations.

“We point out, though, that this scale is from 0.51 to 0.54, so it’s a very tight scale. But even so, we didn’t see an increase in higher-order aberrations,” he said.

The results also showed a high rate of refractive predictability at 12-month follow-up, with 96% of eyes being within 1 D of the targeted manifest refraction spherical equivalent and 69% of eyes being within 0.50 D of targeted refraction, Dr. Slade said.

Also, 95% of the patient group had completed the study at 12 months.

“We feel these are excellent results with good predictability and are planning to submit this to the FDA for approval,” he said.

For more information:

Stephen G. Slade, MD, can be reached at The Laser Center, 3900 Essex, Suite 101, Houston, TX 77027, U.S.A.; +1-713-626-5544; fax: +1-713-626-7744; e-mail: sgs@visiontexas.com. Dr. Slade is a consultant for Bausch & Lomb.

Bausch & Lomb Surgical Inc., maker of the Zyoptix Personalized Laser Vision Correction System, can be reached at 180 Via Verde, San Dimas, CA 91773, U.S.A.; +1-909-971-5100; +1-800-338-2020; fax: +1-800-362-7006; Web site: www.bausch.com.

Matt Hasson is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses on regulatory, legislative and practice management topics.