Jon G. Dishler, M.D., F.A.C.S. announced that on, September 13, 2016, approval has been received from the FDA for the novel treatment of nearsightedness using the SMILE procedure. Dr. Dishler was the first doctor to perform this procedure in North America, and was the Medical Monitor for the pivotal clinical trial which led to this approval along with other investigators from around the country. SMILE is a minimally invasive approach using a femtosecond laser to correct vision with removal of a tiny piece of tissue from within the cornea. The procedure is approved to a broad range of corrections which were previously only treatable with glasses, contact lenses, or LASIK type surgical procedures.
Dr. Dishler presented the first update in the clinical trial leading to the approval in June of 2012 and this data allowed expansion to the full clinical cohort of subjects whose one year post-operative results were deemed safe and effective by FDA resulting in the approval.
“Many individuals have provided excellent work to bring this procedure to the American public and we are pleased to have played a part in this process” said Dr. Dishler and in addition he commented that “This is a new and appealing option for many who have concerns about the existing choices for surgical vision correction. I was very impressed with the excellent refractive outcomes in our clinical study, especially in those patients who were most dependent on their spectacles for daily life.”
To date, a total of approximately 350 patients have been treated within the scope of the trial, at five centers in the USA. Outside the USA there are more than 150 centers in 38 countries with more than 300 surgeons performing the SMILE procedure. Many hundreds of thousands of procedures have been completed at this time worldwide.