WAILEA, Hawaii — A study of 2,000 patients implanted with a
small-aperture corneal inlay with LASIK demonstrated high efficacy and
safety, along with high patient satisfaction and lowered dependence on
reading glasses, a speaker said here.
The analysis examined 2,000
hyperopes, emmetropes and myopes between the ages of 40 and 65 years.
Subjects underwent simultaneous LASIK with implantation of a Kamra intracorneal inlay (AcuFocus), Minoru Tomita, MD, PhD, said at Hawaiian Eye 2012.
The
latest version of the inlay, which is under U.S. investigational device
exemption clinical trial, was used, he said. It measures 3.8 mm in
diameter with a 1.6 mm central aperture and 8,400 holes for oxygen and
nutrition flow.
Patients were examined at 1 month, 3 months, 6 months and 1 year postop.
Subjects achieved uncorrected distance visual acuity of 20/20 by 6 months and maintained 20/20 through 1 year, Dr. Tomita said.
Uncorrected
near visual acuity results by age group showed those in their 40s
gained three Jaeger lines to J2, those in their 50s gained four lines to
J2, and those in their 60s gained five lines to J3. These results were
maintained from 3 months to 1 year, he said.
"For both categories, more than 85% of patients were either satisfied or highly satisfied with the outcome," Dr. Tomita said.
Disclosure:
Dr. Tomita performs contracted research for AcuFocus and has his travel
expenses paid by AcuFocus, Ziemer Ophthalmic Systems and Schwind
eye-tech-solutions.
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