EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/78716
March 2012 EW NEWS & OPINION 3 Impacting ophthalmology by Jena Passut EyeWorld Staff Writer P hysicians continue to face a number of regulatory changes, many of which promise to directly impact how they practice, according to one expert who spoke at the 2012 ASCRS Winter Update in Riviera Maya, Mexico. Nancey K. McCann, ASCRS•ASOA director of government relations, opened the ASOA portion of the meeting by highlighting key issues in healthcare continued on page 4 soon as they express an interest in an indicated LASIK procedure and prior to undergoing surgery, must be given the WaveLight® System Health Care Professional Information Sheet- All WaveLight® Allegretto Wave® Indications The WaveLight® ALLEGRETTO WAVE® ALLEGRETTO WAVE® System / Eye-Q Excimer Laser System CAUTION: Federal (USA) law restricts this device to sale by, or on the order of a physician. Statements regarding the potential benefits of wavefront-guided and Wavefront Optimized® laser-assisted in-situ keratomileusis (LASIK) are based upon the results of clinical trials. These results are indicative of not ony the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Patient Information Booklet and must be informed of the alternatives for refractive correction including eyeglasses, contact lenses, PRK, and other refractive surgeries. Clinical Data Myopia: The WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Eye-Q Excimer Laser System treatment but also the care of the clinical physicians, the control of the surgical environment by those physicians, the clinical trials' treatment parameters and the clinical trials' patient inclusion and exclusion criteria. Although many clinical trial patients after the wavefront-guided and Wavefront Optimized® procedure saw 20/20 or better and/or had or reported having better vision during the day and at night, compared to their vision with glasses or contact lenses before the procedure, individual results may vary. You can find information about the clinical trials below and in the Procudure Manuals for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System. As with any surgical procedure, there are risks associated with the wavefront-guided and Wavefront Optimized® System treatment. Before treating patients with these procedures, you should carefully review the Procedure Manuals, complete the Physician WaveLight® Certification Course, provide your patients with the Patient Information Booklet, and discuss the risks associated with this procedure and questions about the procedure with your patients. INDICATIONS: The WaveLight® WAVE® ALLEGRETTO / ALLEGRETTO WAVE® Eye-Q Excimer Laser System is indicated to perform LASIK treatments in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 diopters (D) of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia in patients 18 years of age or older: for the reduction or elimination of myopic refractive errors up to -12.0 D of sphere with and without astigmatic refractive errors up to -6.0 D; for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; and in patients 21 years of age or older for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.0 D at the spectacle plane. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. Only practitioners who are experienced in the medical management and surgical treatment of the cornea, who have been trained in laser refractive surgery including laser system calibration and operation, may use the device as approved. Prospective patients, as Excimer Laser System for LASIK treatments of myopic refractive errors up to -12.0 D of sphere with and without astigmatic refractive errors up to -6.0 D at the spectacle plane was studied in clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%. The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses. The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months). Long term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied. Clinical Data Hyperopia: The WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System for LASIK treatments of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D with a maximum MRSE of +6.0 D has been studied in clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%. The studies found that of the 212 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5% were corrected to 20/20 or better without spectacles or contact lenses. The study showed that the following subjective patient adverse events were reported as much worse by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3.0%); night driving glare (4.2%); light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%). Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied. Clinical Data Mixed Astigmatism: The WaveLight® WAVE® ALLEGRETTO WAVE® / ALLEGRETTO Eye-Q Excimer Laser System for LASIK treatments of naturally occurring mixed astigmatism of up to 6.0 D at the spectacle plane has been studied in clinical trials in the United States with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%. The studies found that of the 142 eyes eligible for the UCVA analysis of effectiveness at the 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved acuity of 20/20 or better without spectacles or contact lenses. The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months); visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at baseline versus 42.3% at 3 months). Long term risks of LASIK for mixed astigmatism beyond 6 months have not been studied. Clinical Data Wavefront-guided Treatment of Myopia: The WaveLight® / ALLEGRETTO WAVE® ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight® ALLEGRO Analyzer® device. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided LASIK: 1) for the reduction or elimination of up to -7.0 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.0 D of spherical component and up to 3.0 D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery was studied in a randomized clinical trial in the United States with 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized® LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%. The studies found that of the 180 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point in the Study Cohort, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20 or better without spectacles or contact lenses. The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment in the Study Cohort: light sensitivity (37.2% at baseline versus 47.8% at 3 months); and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort: halos (36.6% at baseline versus 45.4% at 3 months); and visual fluctuations (18.3% at baseline versus 21.9% at 3 months). Long term risks of wavefront-guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied. CONTRAINDICATIONS: LASIK treatments using the WaveLight® ALLEGRETTO WAVE® ALLEGRETTO WAVE® / Eye-Q Excimer Laser System are contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; patients with diagnosed keratoconus or any clinical pictures suggestive of keratoconus; and patients who are taking one or both of the following