JUN 04, 2008
This study evaluates the long-term stability of eyes treated with LASIK for hyperopia in the FDA clinical trial of the WaveLight Allegretto Wave Excimer Laser System. Based on the results of that research, the product, which is manufactured by WaveLight AG of Erlangen, Germany, received U.S. marketing approval in 2003 for the treatment of up to 6.00 D spherical equivalent refraction hyperopia with up to 5.00 D astigmatism measured at the corneal plane. The authors of the current study found that subjects demonstrated strong refractive and keratometric stability more than three years after undergoing treatment with the device.
The follow-up study included 127 of 290 eyes (43.8%) of 68 of 151 patients (45%) who participated in the initial study. They were evaluated a mean of 3.9 years and a range of 3.2 to 4.9 years after their six-month follow-up examinations after undergoing LASIK during the clinical trial. The researchers found that 93.7 percent of the eyes displayed manifest refraction spherical equivalent (MRSE) stability within 1.00 D compared with their six-month follow-up results.
Regression of the treatment effect of greater than 1.00 D was measured in 4.7% of subjects and progression in 1.6%. There was a weak correlation seen between refractive changes and keratometry changes in eyes that had undergone treatment of greater than 2.00 D, but this relationship was not significant in eyes that had undergone 2.00 D of treatment or less.
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Dr. Stahl is a consultant for AcuFocus, Inc.