|Approval Order Statement |
Approval to modify the current labeling by 1)updating the clinical results with 12-month data; 2)presenting the 12-month data stratified into three groups (low myopia, low myopia with astigmatism, and high myopia with and without astigmatism) based on preoperative refractive error, and 3) including new contrast sensitivity claims based on a contrast sensitivity study of 284 pts. Other modifications to the labeling include editorial changes, the addition of new data tables reformatted to reflect the revised stratification of data, and the inclusion of a revised contrast sensitivity labeling statement to read: "in a constrast sensitivity study designed to assess theeffects of ladarvision surgery on how well patients can see in conditions such as very dim light, rain, snow, fog or glare from bright lights at night, the percentages of patients showing clinically significant losses were 10. 6% at 6 months and 6. 6% at 12 months after surgery, and the percentages of patients showing clinically significant improvements were 5. 9% at 6 months and 3. 3% at 12 months after surgery. ".