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ICL safe, efficacious treatment for myopia, study says
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SAN DIEGO – Early results of an ongoing U.S. Food and Drug Administration (FDA) myopia clinical trial suggest that Staar Surgical’s Implantable Contact Lens (ICL) is a safe and effective surgical treatment for patients with myopia.
At least 80% of treated eyes achieved an uncorrected visual acuity of 20/40 or better at one week or later after surgery, according to John A Vukich, MD, who presented clinical trial results at the American Society of Cataract and Refractive Surgery, held here. At least 77% of cases are within 1D of emmetropia at 1 week or through 12 months. At all postoperative visits, at least 97% of eyes were within 1 line of their preoperative level, with between 9-13% of eyes experiencing improvements in BSCVA of two lines or more.
According to Dr. Vukich, 12-month data provided excellent predictability of 72% +/- 1 D, efficacy of 20/40 or better in 89% of patients, rapid return of BCVA and a low incidence of lens opacities and rises in IOP.
According to Dr. Vukich, there were no surgical complications; however, one eye lost 5 lines of best corrected visual acuity due to myopic degeneration. This incidence was unrelated to Staar Surgical’s ICL, Dr. Vukich said.
Two ICLs needed to be removed due to an increase in IOP. Adverse events included the removals or replacements of seven ICLs due to sizing issues where the lens was either too big or too small. The adverse events have been correctable, according to Dr. Vukich.
As part of the FDA myopia clinical trial, 579 eyes of 335 patients were treated with the ICL. All patients had had spherical equivalent ranging from –3.0 to –23.50, with less than 2.5D of astigmatism. The mean preoperative spherical equivalent was –10.1D.