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Customized hyperopia treatment with the Technolas 217z Zyoptix wavefront excimer laser system (Bausch & Lomb) has excellent predictability, with 69% of patients within 0.5 D of the intended correction.
Chicago-The 1-year results of the FDA safety and efficacy trial of customized hyperopia treatment with a wavefront excimer laser system (Technolas 217z Zyoptix, Bausch & Lomb) showed that the predictability of the treatment was excellent, with 69% of patients within 0.5 D of the intended correction. Stephen G. Slade, MD, reported the results at the American Society of Cataract and Refractive Surgery annual meeting.
Investigators conducted this 2-year study at four clinical sites. The ablations were determined using Hartmann-Shack aberrometry and corneal topography (Orbscan, Bausch & Lomb). Patients were included if they had up to 4 D of sphere and 4 D of cylinder. A total of 159 eyes of 80 patients ultimately met the study criteria.
"The data were similar for patients who achieved 20/20 or better. There was excellent improvement in the UCVA, with 70% of patients achieving 20/20 or better and 33% of patients achieving 20/16 or better," he said.
Regarding the best-corrected visual acuity (BCVA), of the patients who had 20/40 or better UCVA preoperatively, all had 20/40 or better BCVA at 1 year.
"Slightly less than 85% who had 20/20 or better preoperatively achieved 20/20 or better postoperatively, and 90% achieved that level at the 1-year evaluation; 63% of patients achieved 20/16 or better at 1 year compared with 48% preoperatively," Dr. Slade reported.
"Generally, there were very nice improvements in the UCVA from preoperatively to 12 months. The BCVA levels either stayed the same at the 20/40 best-corrected level preoperatively and at 12 months, but we saw increases in the BCVA levels in the patients with 20/20 and 20/16 vision.
In addition, he pointed out, more patients gained lines of BCVA than patients who lost lines of best-corrected vision.
"In a hyperopia trial, the reverse is expected compared with a myopia trial in which there is a decrease of the minification effect," Dr. Slade said.
He and his colleagues also observed a reduction in the higher-order aberrations from preoperatively to 12 months.
"The predictability of the procedure was very good with 96% of the eyes within 1 D of the intended correction, and 69% of the eyes were within 0.5 D of the target refraction. Ninety-five percent of the patients completed the study to the 1-year evaluation. We think that we achieved excellent results with good predictability. We are planning to submit these data to the FDA in hopes of receiving approval of the procedure," Dr. Slade concluded.