STERLING, Va., March 2006 -(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.
