March 20, 2006 STERLING, Va.--(BUSINESS WIRE)-- At a clinical
course conducted this morning at the American Society of Cataract
and Refractive Surgery (ASCRS) annual meeting in San Francisco,
Guy M. Kezirian, M.D., F.A.C.S and Karl G. Stonecipher, MD, presented
six-month study results comparing outcomes of wavefront-optimized
and wavefront-guided treatments with the ALLEGRETTO WAVE excimer
laser. The study validated that both groups performed similarly
for uncorrected visual acuity (UCVA), manifest refractive spheroequivalent
(MRSE) and postoperative UCVA versus preoperative best spectacle
visual acuity (BSCVA).
The prospective controlled multi-center study was initiated in
September 2004 to evaluate the safety and effectiveness of wavefront-guided
treatments (incorporating the ALLEGRO wavefront analyzer) and to
compare results to wavefront-optimized (standard LASIK) with the
ALLEGRETTO WAVE. Myopic patients (up to +7D with up to +3D of astigmatism)
were eligible to participate in the study. Based on alternating
enrollment, patients were randomized for either wavefront-optimized
or wavefront-guided treatments in both eyes.
At six-months, 93 percent of patients in both study groups achieved
20/20 or better vision. 89 percent of eyes in the wavefront-optimized
cohort and 86 percent of eyes in the wavefront-guided cohort gained
postoperative UCVA as good as or better than their preoperative
BSCVA. MRSE within .5D of target refraction was 93 percent for wavefront-guided
and 94 percent for wavefront-optimized procedures. 58 percent of
eyes in the wavefront-optimized cohort gained one line or more of
vision compared to 62 percent of patients in the wavefront-guided
cohort. No loss in contrast sensitivity was observed with either
platform.
Results demonstrated similar wavefront outcomes in both groups
in eyes with less than 0.3 microns of pre-operative higher-order
aberrations (HOAs) which accounted for approximately 80 percent
of patients. Eyes with 0.3 to 0.4 microns of pre-operative HOAs
demonstrated slightly more improvement with wavefront-guided treatments
than with wavefront-optimized treatments. In cases with more than
0.4 microns of HOA, it was discovered that post-operative HOAs were
reduced in both wavefront-guided and wavefront-guided cohorts. This
was not previously reported.
"These results confirmed that wavefront-optimized treatments
did not, on average, affect higher-order aberrations," stated Guy
M. Kezirian, M.D., F.A.C.S., president and founder of SurgiVision(R)
Regulatory Consultants, Inc. "Since most eyes have low amounts of
preoperative higher-order aberrations, the wavefront-optimized approach
will allow doctors to avoid the added time and expense of performing
customized wavefront-guided treatments, which have been shown to
improve outcomes in only approximately one in five eyes. The key
to success in most eyes is to treat the refractive error and leave
the higher-order aberrations alone."
WaveLight's clinical investigator group includes Stephen Brint,
M.D., F.A.C.S., Michael Gordon, M.D., Karl Stonecipher, M.D., Bennett
Chotiner, M.D., F.A.C.S., David Dulaney, M.D. and Charles R. Moore,
M.D., F.I.C.S. The study is being administered by SurgiVision Regulatory
Consultants, Inc. of Scottsdale, AZ.
The ALLEGRETTO WAVE was the first refractive laser to receive
concurrent approvals for the treatment of myopia up to -12 diopters
with astigmatism of up to -6 diopters and hyperopia up to +6 diopters
with astigmatism of up to +5 diopters, not exceeding a mean spherical
equivalent of +6 diopters.
WaveLight AG (ISIN DE 000 512 5603)
WaveLight AG, listed in Deutsche Borse AG's Prime Standard since
January 2003, develops, produces, and markets a high-quality, end-to-end
product portfolio in the fields of ophthalmology and aesthetics.
WaveLight's market success is based on its innovative range of products
that are the technology leaders in their areas of application and
its broad-based sales network featuring both own sales channels
and strategic partners. In the past fiscal year 2004/2005, WaveLight
generated revenues of EUR 80.7 million and EBIT of EUR 8.8 million.
Its average growth rate (CAGR) since 2000/2001 amounts to 35 percent
for revenues and 63 percent for EBIT.
Further information on WaveLight is available at:
Wavelight.
