An FDA panel said the agency should improve its guidance on risks
from laser-vision eye surgery, following testimony from people about harm they
suffered in botched procedures.
While past studies generally have found that 95% of Lasik
patients are satisfied with their surgery, some patients have complained the
surgery left them with damaged eyes and psychological problems.
Among other steps, the Food and Drug Administration panel, which
included doctors alongside industry, consumer and patient representatives, said
the agency needs to include more details in its patient labeling and Web site.
Patient labeling for Lasik surgeries should include information on possible
complications for Lasik patients who seek cataract surgery later in life,
information on possible correlation between hormonal treatments and dry eye for
Lasik patients and pictures of common symptoms of patients who have experienced
a decline in visual quality, according to the panel.
The panel also said an FDA Web site on Lasik treatments
should include statistics on risks of the surgery, clearer and more coherent
writing and further information on patients' need for reading glasses when they
reach middle age. And it recommended that a system that reports adverse medical
incidents associated with Lasik include not only incidents related to visual
acuity but to quality of vision. The broader designation would encompass visual
"glares," "starbursts" and "halos" commonly
reported by patients with
Lasik surgery is the common term for the most common type of
vision-correction surgery. Doctors who perform Lasik surgeries have mounted a
defense of the surgeries, which the FDA said are performed approximately
700,000 times each year.
The American Society of Cataract and Refractive Surgery has
touted the results of a "meta-analysis" of thousands of studies
showing that over 95% of patients are satisfied with the Lasik procedure and
would recommend it to a friend or elect to undergo the procedure again.
"The question is which one of this painting of the Lasik
picture is true," panel Chairwoman Jayne S. Weiss said. "And
obviously, they're both true."
The FDA recently recruited the National Eye Institute, part of
the National Institutes of Health, to study how patients' quality of life has
been affected by laser eye surgery, beyond helping to correct their vision. Eye
doctors are hoping the study will shed light on the incidence of
dissatisfaction with laser eye surgery and lead to ways to shrink the risk of
problems.
Jason
