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Femtosecond laser lenticule extraction (small-incision lenticule extraction) performed to treat spherical myopia resulted in rapid and significant improvements in visual acuity. John Doane, MD, reported the preliminary data from the U.S. clinical trial.
Boston-Femtosecond laser lenticule extraction (small-incision lenticule extraction) performed to treat spherical myopia resulted in rapid and significant improvements in visual acuity. John Doane, MD, reported the preliminary data from the U.S. clinical trial.
Patients included in the multicenter single-eye study were 22 years of age and older with from 1 to 10 D of myopia (mean spherical equivalent, –4.66 D). One eye of each patient was treated using a femtosecond laser (VisuMax, Carl Zeiss Meditec).
A total of 318 patients (180 women, 135 men; average age, 33 years) were treated. The data reflect treatments in 315 eyes, said Dr. Doane, in private practice, Leawood, KS.
The postoperative manifest refraction spherical equivalent (MRSE) was –0.14 D at 7 days and essentially the same at 1, 3, and 6 months postoperatively. Interestingly, patients with higher refractive errors had basically the same response as those with lower refractive errors, Dr. Doane noted.
“The procedure was very predictable across the refractive spectrum,” he said.
Dr. Doane speculated that the procedure was so predictable because it is performed inside the cornea in a vacuum that eliminated the effects of environmental parameters of temperature and humidity.
The efficacy evaluation indicated that at 12 months 96% of patients were within ±0.5 D of the intended correction. At 9 months, 93% of eyes were 20/20 or better uncorrected and at 1 year, in 94% of patients were 20/20 or better uncorrected.
“The great result is that the gained lines exceeded the lines lost at 6, 9, and 12 months,” he said.
Loss of suction is a possible problem with this technique; this occurred in six patients in this study (treatment was discontinued in two and completed in four). With eight patients the lenticule removal was difficult without tissue damage.
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