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Overall, acute endothelial cell loss rates were about 6% for boththe central and peripheral cornea.
"Based on analyses conducted for patients followed for at least 6 months, the performance of this phakic implant has been very promising so far, and we look forward to continuing to evaluate it in further studies," said Dr. Krueger, director, refractive surgery, Cole Eye Institute, The Cleveland Clinic Foundation, Cleveland.
Mean manifest refractive spherical equivalent (MRSE) for the 60 eyes was –10.09 D preoperatively. On the first day after surgery, mean MRSE was 0.06 D, and it remained stable through follow-up to 6 months. At 6 months, refractive predictability results for percentages of eyes within ±0.5 D and ±1.0 D of intended MRSE well-exceeded FDA guidance criteria with 98% of eyes being ±1.0 D and 90% within 0.5 D of intended.
"These are very good results for this high range of myopia," Dr. Krueger said.