Eyeworld Supplements

Astigmatism Management decreased due to this event. The second event involved the treatment of an incorrect axis of astigmatism. The axis was treated at 60 degrees instead of 160 degrees. The following complications were reported 6 months after LASIK: 1.8% (2/111) of the eyes had ghosting or double images in the opera- tive eye. Wavefront-Guided Myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized ® LASIK (Control Cohort). No adverse events occurred during the postoperative period of the wavefront-guided LASIK procedures. In the Control Cohort, one subject undergoing traditional LASIK had the axis of astigmatism programmed as 115 degrees instead of the actual 155 degree axis. This led to cylin- der in the left eye. The following complications were reported 6 months after wave- front-guided LASIK in the Study Cohort: 1.2% (2/166) of the eyes had a corneal epithelial defect; 1.2% (2/166) had foreign body sensation; and 0.6% (1/166) had pain. No complications were reported in the Control Cohort. Topography-Guided Myopia: There were six adverse events reported in the topography-guided myopia study. Four of the eyes experienced transient or temporary decreases in vision prior to the final 12-month follow-up visit, all of which were resolved by the final follow-up visit. One subject suffered from decreased vision in the treated eye, follow- ing blunt force trauma 4 days after surgery. One subject experienced retinal detachment, which was concluded to be unrelated to the surgi- cal procedure. Clinical Data Myopia: The myopia clinical study included 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%. Of the 782 eyes that were eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 98.3% were corrected to 20/40 or better, and 87.7% were cor- rected to 20/20 or better. Subjects who responded to a patient satis- faction questionnaire before and after LASIK reported the following visual symptoms at a "moderate" or "severe" level at least 1% higher at 3 months post-treatment than at baseline: visual fluctuations (28.6% vs. 12.8% at baseline). Long-term risks of LASIK for myopia with and without astigmatism have not been studied beyond 12 months. Hyperopia: The hyperopia clinical study included 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Ac- countability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%. Of the 212 eyes that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 69.4% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction question- naire before and after LASIK reported the following visual symptoms as "much worse" at 6 months post-treatment: halos (6.4%); visual fluctua- tions (6.1%); light sensitivity (4.9%); night driving glare (4.2%); and glare from bright lights (3.0%). Long-term risks of LASIK for hyperopia with and without astigma- tism have not been studied beyond 12 months. Mixed Astigmatism: The mixed astigmatism clinical study included 162 eyes treated, of which 111 were eligible to be followed for 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%. Of the 142 eyes that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 97.3% achieved acuity of 20/40 or better, and 69.4% achieved acuity of 20/20 or better. Subjects who responded to a patient satisfaction ques- tionnaire before and after LASIK reported the following visual symp- toms at a "moderate" or "severe" level at least 1% higher at 3 months post-treatment than at baseline: sensitivity to light (52.9% vs. 43.3% at baseline); visual fluctuations (43.0% vs. 32.1% at baseline); and halos (42.3% vs. 37.0% at baseline). Long-term risks of LASIK for mixed astigmatism have not been studied beyond 6 months. Wavefront-Guided Myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized® LASIK (Control Cohort). 166 of the Study Cohort and 166 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%. Of the 166 eyes in the Study Cohort that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or bet- ter. Of the 166 eyes in the Control Cohort eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were correct- ed to 20/40 or better, and 92.8% were corrected to 20/20. In the Study Cohort, subjects who responded to a patient satis- faction questionnaire before and after LASIK reported the following visual symptoms at a "moderate" or "severe" level at least 1% higher at 3 months post-treatment than at baseline: light sensitivity (47.8% vs. 37.2% at baseline) and visual fluctuations (20.0% vs. 13.8% at baseline). In the Control Cohort, the following visual symptoms were report- ed at a "moderate" or "severe" level at least 1% higher at 3 months post-treatment than at baseline: halos (45.4% vs. 36.6% at baseline) and visual fluctuations (21.9% vs. 18.3% at baseline). Long-term risks of wavefront-guided LASIK for myopia with and without astigmatism have not been studied beyond 6 months. Topography-Guided Myopia: The topography-guided myopia clinical study included 249 eyes treated, of which 230 eyes were followed for 12 months. Accountability at 3 months was 99.2%, at 6 months was 98.0%, and at 12 months was 92.4%. Of the 247 eyes that were eligible for the UCVA analysis at the 3-month stability time point, 99.2% were corrected to 20/40 or better, and 92.7% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms as "marked" or "severe" at an incidence greater than 5% at 1 month after surgery: dryness (7% vs. 4% at baseline) and light sensitivity (7% vs. 5% at baseline). Visual symptoms continued to improve with time, and none of the visual symptoms were rated as being "marked" or "severe" with an incidence of at least 5% at 3 months or later after surgery. Long-term risks of topography-guided LASIK for myopia with and without astigmatism have not been studied beyond 12 months. Information for Patients: Prior to undergoing LASIK surgery with a WaveLight ® Excimer Laser System, prospective patients must receive a copy of the relevant Patient Information Booklet, and must be informed of the alternatives for correcting their vision, including (but not limited to) eyeglasses, contact lenses, photorefractive keratectomy, and other refractive surgeries. Attention: Please refer to a current WaveLight ® Excimer Laser System Procedure Manual for a complete listing of the indications, complica- tions, warnings, precautions, and side effects. * Trademarks are property of their respective owners. © 2017 Novartis 5/17 US-WVL-17-E-1093 8

• Cover