Eyeworld Daily News

2017 ASCRS Los Angeles Daily Sunday

EyeWorld Today is the official daily of the ASCRS Symposium & Congress. Each issue provides comprehensive coverage editorial coverage of meeting presentations, events, and breaking news

Issue link: https://daily.eyeworld.org/i/820839

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Page 111 of 112

This information pertains to all WaveLight ® Excimer Laser Systems, including the WaveLight® ALLEGRETTO WAVE ® , the ALLEGRETTO WAVE ® Eye-Q , and the WaveLight® EX500. Caution: Federal (U.S.) law restricts the WaveLight ® Excimer Laser Sys- tems to sale by or on the order of a physician. 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 calibration and operation) should use a WaveLight ® Excimer Laser System. Indications: FDA has approved the WaveLight ® Excimer Laser systems for use in laser-assisted in situ keratomileusis (LASIK) treatments for: • the reduction or elimination of myopia of up to –12.00 D and up to 6.00 D of astigmatism at the spectacle plane; • the reduction or elimination of hyperopia up to + 6.00 D with and without astigmatic refractive errors up to 5.00 D at the spectacle plane, with a maximum manifest refraction spherical equivalent of + 6.00 D; • the reduction or elimination of naturally occurring mixed astigma- tism of up to 6.00 D at the spectacle plane; and • the wavefront-guided reduction or elimination of myopia of up to –7.00 D and up to 3.00 D of astigmatism at the spectacle plane. In addition, FDA has approved the WaveLight® ALLEGRETTO WAVE ® Eye-Q Excimer Laser System, when used with the WaveLight ® ALLEGRO Topolyzer ® and topography-guided treatment planning software for topography-guided LASIK treatments for the reduction or elimination of up to –9.00 D of myopia, or for the reduction or elimination of myo- pia with astigmatism, with up to –8.00 D of myopia and up to 3.00 D of astigmatism. The WaveLight ® Excimer Laser Systems are only indicated for use in patients who are 18 years of age or older (21 years of age or older for mixed astigmatism) with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia. Contraindications: The WaveLight ® Excimer Laser Systems are contra- indicated for use with patients who: • are pregnant or nursing; • have a diagnosed collagen vascular, autoimmune or immunodeficien- cy disease; • have been diagnosed keratoconus or if there are any clinical pictures suggestive of keratoconus; • are taking isotretinoin (Accutane*) and/or amiodarone hydrochloride (Cordarone*); • have severe dry eye; • have corneas too thin for LASIK; • have recurrent corneal erosion; • have advanced glaucoma; or • have uncontrolled diabetes. Warnings: The WaveLight ® Excimer Laser Systems are not recommend- ed for use with patients who have: • systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; • a history of Herpes simplex or Herpes zoster keratitis; • significant dry eye that is unresponsive to treatment; • severe allergies; • a history of glaucoma; • an unreliable preoperative wavefront examination that precludes wavefront-guided treatment; or • a poor quality preoperative topography map that precludes topogra- phy-guided LASIK treatment. The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wave- front-guided LASIK procedure must be validated by the user. Inaccu- rate or unreliable data from the wavefront examination will lead to an inaccurate treatment. Topography-guided LASIK requires preoperative topography maps of sufficient quality to use for planning a topography-guided LASIK treatment. Poor quality topography maps may affect the accuracy of the topography-guided LASIK treatment and may result in poor vision after topography-guided LASIK. Precautions: The safety and effectiveness of the WaveLight® Excimer Laser Systems have not been established for patients with: • progressive myopia, hyperopia, astigmatism and/or mixed astig- matism, ocular disease, previous corneal or intraocular surgery, or trauma in the ablation zone; • corneal abnormalities including, but not limited to, scars, irregular astigmatism and corneal warpage; • residual corneal thickness after ablation of less than 250 microns due to the increased risk for corneal ectasia; • pupil size below 7.0 mm after mydriatics where applied for wave- front-guided ablation planning; • history of glaucoma or ocular hypertension of >23 mmHg; taking the medications sumatriptan succinate (Imitrex*); • corneal, lens and/or vitreous opacities including, but not limited to cataract; • iris problems including , but not limited to, coloboma and previous iris surgery compromising proper eye tracking; or • taking medications likely to affect wound healing including (but not limited to) antimetabolites. In addition, safety and effectiveness of the WaveLight® Excimer Laser Systems have not been established for: • treatments with an optical zone <6.0 mm or >6.5 mm in diameter, or an ablation zone >9.0 mm in diameter; or • wavefront-guided treatment targets different from emmetropia (pla- no) in which the wavefront calculated defocus (spherical term) has been adjusted; In the WaveLight ® Excimer Laser System clinical studies, there were few subjects with cylinder amounts >4 D and ≤6 D. Not all com- plications, adverse events, and levels of effectiveness may have been determined for this population. Pupil sizes should be evaluated under mesopic illumination condi- tions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery. Adverse Events and Complications Myopia: In the myopia clinical study, 0.2% (2/876) of the eyes had a lost, misplaced, or misaligned flap reported at the 1-month examina- tion. The following complications were reported 6 months after LASIK: 0.9% (7/818) had ghosting or double images in the operative eye; 0.1% (1/818) of the eyes had a corneal epithelial defect. Hyperopia: In the hyperopia clinical study, 0.4% (1/276) of the eyes had a retinal detachment or retinal vascular accident reported at the 3-month examination. The following complications were reported 6 months after LASIK: 0.8% (2/262) of the eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface. Mixed Astigmatism: In the mixed astigmatism clinical study, two adverse events were reported. The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye 6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. UCVA was WaveLight® Excimer Laser Systems Important Product Information 7

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