- USAEYES certification standards are below the standard of care as
evidenced by published FDA clinical trials. Therefore, no evidence
exists that USAEYES surgeons are better than non-certified surgeons.
Upon careful examination of the requirements for certification, it is
evident that the efficacy requirements actually fall far below
today’s standards and results achieved in FDA clinical trials
completed in 2002 and 2003. Here is an example of surgical outcomes
requirements from the USAEYES.org website:
"Not less than 90% of applicant's refractive surgery patients
must achieve Snellen 20/40 Uncorrected Visual Acuity (UCVA) or better
in each surgical eye. Not less than 50% of applicant's refractive
surgery patients must achieve Snellen 20/20 UCVA or better in each
surgical eye."
Source:
http://www.usaeyes.org/faq/subjects/outcomes_requirements.htm
In comparison, at 6 months post-op, 99.4% of eyes enrolled in the
Bausch & Lomb Zyoptix clinical trials achieved UCVA of 20/40 or
better and 91.5% achieved UCVA of 20/20 or better.
Source:
www.fda.gov/cdrh/pdf/P990027S006b.pdf
Similarly, six month post-operative UCVA data from the VISX STAR S4
WaveFront System shows that 99.6% of eyes achieved 20/40 or better and
93.9% achieved 20/20 or better.
Source:
www.fda.gov/cdrh/pdf/P930016s016b.pdf
The Alcon LADARVision 4000 wavefront-guided LASIK trials resulted in
98.6% of eyes with UCVA of 20/40 or better and 79.9% with 20/20 or
better.
Source:
www.fda.gov/cdrh/pdf/P970043S010b.pdf
These lasers represent the vast majority of lasers in use for refractive
surgery in the United States today. USAEYES’ UCVA standards for
certification are similar to outcomes seen with obsolete,
first-generation laser technology from the late 1990s. Clearly the
surgical outcome requirements are not superior, yet USAEYES issues a
meritless "certification" to a surgeon who pays a fee for use
of the logo, which is then used by the surgeon in the advertisement and
promotion of LASIK surgery. This misleads patients into believing they
are choosing one of the best when in reality the certification is
nothing more than a gimmick for the promotion and marketing of LASIK.
- Lack of adequate sampling to sustain claims
USAEYES requires data from 125 patients for initial certification and
again every other fiscal year for re-certification. This represents a
very small percentage of patients in a busy refractive surgery
practice. The audit procedures state that a surgeon;
"may be requested to provide patient chart information when
requested, not more than ten charts per fiscal year, and onsite
audits are normally performed every 18 months, however may be
performed more or less often at CRSQA's discretion."
Source:
http://www.usaeyes.org/faq/certification_request.htm
These certification and audit procedures are too limited to represent
the overall outcomes of even a small practice, and the standards are too
loose to ensure that surgeons have demonstrated superior outcomes.
- USAEYES makes claims made in the absence of consensual, scientific
standards.
Regarding complications and adverse events, the organization
states the following requirements for certification:
"Not more than 3% of applicant's monitored refractive surgery
patients may report debilitating refractive surgery complications such
as glare, haze, halo, etc."
Source:
http://www.usaeyes.org/faq/certification_request.htm
These terms are vague and there is no consensus among refractive
surgeons as to their meaning. It is known that reduced visual quality in
dim light (starbursts, halos) occurs frequently after LASIK. The term
"glare" is misused. Prior to laser eye surgery a prospective
patient understands the word "glare" to mean "an intense,
blinding light". Post-LASIK "glare" is not actually glare
– it is a degraded retinal image induced by the laser treatment where
the peripheral cornea refracts light differently than the central
cornea. The word "debilitating" is also not defined and there
is no distinction between a complication that is debilitating and one
that is not. Until the industry can agree upon standardized terms and
objective tests to quantify loss of visual quality and complications,
USAEYES cannot demonstrate consistency with recording and reporting of
these complications. Therefore, to state that a USAEYES certified
surgeon’s complication rate is 3% or less is misleading and
unsubstantiated.
- USAEYES uses inadequate sampling methods to substantiate
it’s claims
Claims aimed at patients, such as "patient satisfaction
surveys are evaluated every fiscal quarter" are internally
inconsistent with other statements on the web site aimed at recruiting
doctors such as, "we do not contact the patients directly"
and "after initial certification, each quarter CRSQA will
evaluate any patient complaints or patient satisfaction surveys as an
indication if additional investigation is warranted."
Source:
http://www.usaeyes.org/faq/subjects/certified.htm
and http://www.usaeyes.org/faq/certification_request.htm
The statement aimed at patients is deliberately misleading as there
are apparently no tight controls or procedures to ensure the gathering
and submission of satisfaction surveys. Essentially it appears the
doctors are monitoring themselves.
