Results from the first clinical trial of myopic LASIK with a new advanced wavefront-guided system are excellent and indicate the procedure is an acceptable and efficacious alternative to conventional LASIK, said W. Bruce Jackson, MD.
Chicago-Results from the first clinical trial of myopic LASIK with a new advanced wavefront-guided system are excellent and indicate the procedure is an acceptable and efficacious alternative to conventional LASIK, said W. Bruce Jackson, MD.
The treatment is performed using an excimer laser (VISX Star S4 IR, Abbott Medical Optics [AMO]) and data acquired with technology (iDesign Advanced WaveScan Studio, AMO) that takes five measurements (wavefront aberrometry, autorefraction, topography, keratometry, and pupillometry). The new device incorporates a high-definition Hartmann-Schack sensor, which has both five times higher resolution than the current WaveScan unit and a greater dynamic range, and it features a non-placido-based corneal topographer that aligns with the same axis as the aberrometer.
Dr. Jackson presented outcomes at 6 months for 108 eyes enrolled in the myopic cohort of the study, which was conducted at four sites in Canada. Eligible patients had myopia with or without astigmatism with MRSE up to –15 D and cylinder up to –6 D. Preoperatively, their mean SE was –4.42 D with a range to –9.50 D and cylinder averaged –1.27 D with a range to –5.25 D.
At 6 months, uncorrected visual acuity (UCVA) was 20/16 or better in 77% of eyes and 20/20 or better in 93%, 81% of eyes were within 0.5 D of their target MRSE, 57% gained at least 1 line of best-corrected visual acuity (BCVA), and 12% lost up to 1 line of BCVA. With eyes stratified by amount of preoperative myopia, the results showed some drop-off in UCVA outcomes and predictability in the high versus low myopia groups.
There was good refractive stability between 1 and 6 months with almost 99% of eyes showing a change of 0.5 D or less, and no serious complications were encountered.
“Overall, I think these are excellent results for the first clinical study using this new advanced aberrometry system and keeping in mind we used a prototype unit and without any physician adjustment,” Dr. Jackson said.
“Particularly interesting was that these seem to be our happiest LASIK patients,” he said. “Patients we treat with wavefront-guided LASIK are happy, but these study patients were exceptionally happy and remain so. Although the subjective data are not yet fully analyzed, from the patients’ perspectives on satisfaction and other outcomes, we’ve never seen such a happy group.”
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