Los Angeles-Wavefront-guided LASIK using the CustomCornea platform (Alcon Laboratories) yields superior outcomes compared with conventional LASIK when treating hyperopia and hyperopic astigmatism, said James J. Salz, MD.
Dr. Salz presented results from 6 months of follow-up for 239 eyes treated in a multicenter study of CustomCornea hyperopic LASIK and compared the findings with those achieved from a historical group of 95 eyes treated with conventional LASIK with the same laser (LADARVision 4000, Alcon) for a matching preoperative refractive range.
The custom treatment was associated with equal or better high-contrast visual acuity, predictability, and mesopic contrast sensitivity. There were significant differences favoring the custom treatment in analyses of low-contrast uncorrected visual acuity (UCVA), low-contrast best spectacle-corrected visual acuity (BSCVA), change in photopic contrast sensitivity, and for minimizing induction of higher-order aberrations.
The FDA approved the CustomCornea procedure on both the LADARVision 6000 laser (Alcon) and the LADARVision 4000 system for the treatment of hyperopia and hyperopic astigmatism (0.75 to 5 D sphere and up to –3 D cylinder) in May 2006. Dr. Salz is the national medical monitor of the Alcon LADARVision FDA studies.
In the data that Dr. Salz presented, treatment for conventional LASIK was based on cycloplegic phoropter refraction. The wavefront-guided procedures were based on up to 6th order higher-order aberrations measured with the LADARWave (Alcon) aberrometer. A total of 258 eyes were treated with customized ablations, of which 239 were seen at 6 months.
At 6 months, a slightly higher proportion of eyes in the custom group compared with the conventional group achieved 20/20 or better in high-contrast UCVA testing, 63% versus 55%, and a similar difference was noted between groups in comparing proportions of eyes achieving 20/25 or better, 83% versus 76%. Considering only the 226 custom-treated eyes with a preoperative BSCVA of 20/20 or better, 66% achieved postoperative UCVA of 20/20 or better. In both the custom and conventional LASIK groups, 96% of eyes achieved 20/40 or better UCVA.