WASHINGTON DC, March 17, 2008 -- In 2006,
in response to complaints received from concerned citizens
regarding LASIK complications affecting patient's quality
of life (QOL), FDA re-evaluated symptom
and QOL data submitted to the agency for the approval of LASIK
lasers and reviewed the medical literature for similar
information.
See
FDA Lasik Complication and Quality of Life for additional
details.
The FDA noted that the available clinical data failed to
suggest significant problems following LASIK surgery. The data
showed that the vast majority of patients were satisfied with
their outcomes; however, a small percentage of patients were
dissatisfied. The FDA also noted that QOL issues related to LASIK had
not been evaluated consistently, and there were few reports of
well-designed studies of QOL post-LASIK.
To accurately quantitate the small proportion of dissatisfied
LASIK patients and evaluate the reasons for their
dissatisfaction, a large, national, prospective study was needed
to help the FDA address this important public health
issue. The FDA solicited the cooperation of the National Eye
Institute (NEI) of the National Institutes of Health and two
large ophthalmic professional societies, the American Society of
Cataract and Refractive Surgeons (ASCRS) and the American
Academy of Ophthalmology (AAO). As a result of FDA's outreach
efforts, FDA, NEI, ASCRS, and AAO formed the joint LASIK Study
Task Force. This task force is designing and facilitating a
clinical trial to investigate QOL after LASIK that will be
conducted by refractive surgeons across the country.
As a preliminary step of this project, a pilot study is
currently underway at NEI Clinical Center. This pilot will
assist FDA and NEI to further develop adequate tools for the
assessment of QOL related to Lasik outcomes.
The results of all studies will be made publicly available.
FDA's LASIK website will continue to be updated to reflect any
new risks found to be supported by adequate scientific evidence.
