FDA Hears USAEyes Competence Opinion Relative to Expectation (CORE) Lasik Quality of Life Patient Survey
WASHINGTON DC, April 25, 2008
More than 99% of patients report their quality of life after laser vision correction surgery is as they had expected or better, even though 2% report complications that are frequently or always problematic, according to a national patient survey conducted by the nonprofit Council or Refractive Surgery Quality Assurance (USAEyes). Preliminary results of the USAEyes Competence Opinion Relative to Expectation (CORE) patient survey are being presented to the US Food and Drug Administration during a special hearing today.
"The USAEyes CORE survey is designed to determine if patients are getting what they expect from Lasik and similar eye surgery," says Glenn Hagele, Executive Director of the nonprofit patient advocacy that conducted the study. "Relevant questions ask if the patient's results were 'as expected', or degrees of 'better than expected' or 'worse than expected'." The survey is used to screen Lasik doctors for certification by USAEyes.
The survey was mailed to 1,800 vision correction surgery patients of six doctors throughout the US, with a 31% response rate.
USAEyes CORE Survey Sample and Details
"It is not surprising that the vast majority of Lasik patients are satisfied with their results, but what was unexpected was that many would have the surgery again despite reporting complications," reports Hagele.
Of those who reported complications that were "seldom problematic", 91% would have the surgery again. A surprising 22% of patients who reported complications that were "frequently" or "always" problematic would have the surgery again, according to patients who responded to the survey. "Clearly some patients find the convenience of a reduced need for glasses and contacts worth occasional problems," says Hagele.
Additional results of the USAEyes CORE patient survey:
99% report quality of life as expected, better, or much better after vision correction surgery
98% state day vision as expected, better, or much better
98% report no complications or complications that are seldom problematic
98% would recommend surgery to family and friends.
97% would have surgery again, knowing what they know now
96% wear corrective lenses as often as expected, less than expected, or much less than expected
96% report postop vision without lenses as expected, better, or much better than expected when compared to preop vision with lenses
96% report overall quality of vision as expected, better, or much better than expected
91% report no complications at any time
91% state night vision as expected, better, or much better than expected
7% report complications seldom problematic, however 91% of these same patients would have surgery again
2% report complications frequent or always problematic, however 22% of these same patients would have surgery again