EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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4 EW NEWS & OPINION March 2012 EyeWorld@EWNews Keep up on the latest in ophthalmology! Follow EyeWorld on Twitter at twitter.com/EWNews Find us on social media facebook.com/EyeWorldMagazine Are you a fan of EyeWorld? Like us on Facebook at medications: isotretinoin (Accutane® hydrochloride (Cordarone® 2). WARNINGS: Any LASIK treatment with the WaveLight® WAVE® ALLEGRETTO WAVE® Eye-Q Excimer Laser System is not recommended in 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; and unreliable preoperative wavefront examination that precludes wavefront-guided 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 wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment. PRECAUTIONS: Safety and effectiveness of the WaveLight® WAVE® ALLEGRETTO WAVE® / ALLEGRETTO Eye-Q Excimer Laser System have not been established for patients with: progressive myopia, hyperopia, astigmatism and/or mixed astigmatism; 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 increasing the risk for corneal ectasia; pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablation planning; history of glaucoma or ocular hypertension of > 23 mmHg; taking the medication sumatriptan succinate (Imitrex® 3); under 18 years (21 years for mixed astigmatism) of age; over the long term (more than 12 months after surgery); 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 eyetracking; taking medications likely to affect wound healing including, but not limited to, antimetabolites; treatments with an optical zone below 6.0 mm or above 6.5 mm in diameter; treatment targets different from emmetropia (plano) in which the wavefront-calculated defocus (spherical term) has been adjusted; myopia greater than – 12.0 D or astigmatism greater than 6 D; hyperopia greater than + 6.0 D or astigmatism greater than 5.0 D; mixed astigmatism greater than + 6.0 D; and in cylinder amounts > 4.0 to < 6.0 D. Due to the lack of large numbers of patients in the general population, there are few subjects with cylinder amounts in this range to be studied. Not all complications, adverse events, and levels of effectiveness may have been determined. Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery. Some patients may find it more difficult to see in such conditions as very dim light, rain, fog, snow and glare from bright lights. This has been shown to occur more frequently in the presence of residual refractive error and perhaps in patients with pupil sizes larger than the optical zone size. The refraction is determined in the spectacle plane, but treated in the corneal plane. In order to determine the right treatment program to achieve the right correction, assessment of the vertex distance during refraction testing is recommended. Preoperative evaluation for dry eyes should / ALLEGRETTO 1), amiodarone be performed. Patients should be advised of the potential for dry eyes post LASIK and post wavefront-guided LASIK surgery. This treatment can only be provided by a licensed healthcare professional. Adverse Events and Complications for Myopia: Certain adverse events and complications occurred after the LASIK surgery. Two adverse events occurred during the postoperative period of the clinical study: 0.2% (2/876) had a lost, misplaced, or misaligned flap reported at the 1 month examination. The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment, corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of >1 mm2; epithelium of >1 mm2 in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of >5 mmHg or any reading above 25 mmHg; retinal detachment or retinal vascular accident; and decrease in BSCVA of >10 letters not due to irregular astigmatism as shown by hard contact lens refraction. The following complications occurred 3 months after LASIK during this clinical trial: 0.8% (7/844) of eyes had a corneal epithelial defect; 0.1% (1/844) had any epithelium in the interface; 0.1% (1/844) had foreign body sensation; 0.2% (2/844) had pain; and 0.7% (6/844) had ghosting or double images in the operative eye. The following complications did NOT occur 3 months following LASIK in this clinical trial: corneal edema and need for lifting and/or reseating the flap/cap. Adverse Events and Complications for Hyperopia: Certain adverse events and complications occurred after the LASIK surgery. Only one adverse event occurred during the clinical study: one eye (0.4%) had a retinal detachment or retinal vascular accident reported at the 3 month examination. The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm2; epithelium of > 1 mm2 in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction. The following complications occurred 6 months after LASIK during this clinical trial: 0.8% (2/262) of eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface. The following complications did NOT occur 6 months following LASIK in this clinical trial: corneal edema; foreign body sensation; pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap. Adverse Events and Complications for Mixed Astigmatism: Certain adverse events and complications occurred after the LASIK surgery. No protocol defined adverse events occurred during the clinical study. However, two events occurred which were reported to the FDA as Adverse Events. 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. The second event involved the treatment of Impacting continued from page 3 and Medicare reform, including the ever-present push to repeal and replace the sustainable growth rate formula (SGR). In breaking news, Ms. McCann announced that the House and Senate had just passed the 10-month extension of the payroll tax holiday, unemployment benefits, and the current Medicare physician payment levels through the end of 2012. Specifically, this is a temporary re- an incorrect axis of astigmatism which required retreatment. The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; corneal epithelial defect involving the keratectomy at 1 month or later; corneal edema at 1 month or later visible in the slit lamp exam; epithelium of > 1 mm2 in the interface with loss of 2 lines or more of BSCVA; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction; any complication leading to intraocular surgery; melting of the flap of > 1 mm2; uncontrolled IOP rise and retinal detachment or retinal vascular accident. None of the following complications occurred at 3 months after LASIK during this clinical trial: corneal edema; corneal epithelial defect; any epithelium in the interface; foreign body sensation, pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap. Subjects were asked to complete a patient questionnaire preoperatively and at 3-months, 6-months, and 1-year postoperatively. Adverse Events and Complications for Wavefront - guided Myopia: Certain adverse events and complications occurred after the wavefront-guided LASIK surgery. No adverse event occurred during wavefront-guided treatments during this clinical study. The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced or misaligned flap or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm2; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg; and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction. The following complications occurred 3 months after wavefront-guided LASIK during this clinical trial: corneal epithelial defect (0.6%); foreign body sensation (0.6%); and pain (0.6%). The following complications did NOT occur 3 months following wavefront-guided LASIK in this clinical trial: corneal edema; any epithelium in the interface; ghosting or double images; and need for lifting and/or reseating of the flap/cap. ATTENTION: The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0 – 6.5 mm and an ablation zone of 9.0 mm. Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. 1. Accutane® is a registered trademark of Hoffmann-La Roche Inc. 2. Cordarone® is a registered trademark of Sanofi S.A. 3. Imitrex® is a registered trademark of Glaxo Group Limited prieve from the 27.4% Medicare physician payment cut, which was scheduled to go into effect on March 1. Physicians now face a 32% cut on January 1, 2013. Ms. McCann said the physician community is vehe- mently opposed to any short-term fix because it exacerbates the prob- lem and causes the cost of a long- term fix to continue to increase. "Instead of fixing the problem, they have put another Band-Aid on it," she said, adding that repealing the SGR now will cost nearly $400 billion, as opposed to the $40 billion it would have cost 10 years ago. Ms. McCann also pointed out other issues important to the ASCRS and ASOA community, including opposition to the creation of an In- dependent Medicare Advisory Board, which she called a "huge, huge dan- ger" because of the power it gives a group of 15 people appointed by the president who would be responsible for recommending payment policies for Medicare. The board would make recommendations for cuts to physi- cians' Medicare reimbursements, and Congress would have to over- turn it by a two-thirds majority. Healthcare/Medicare reform continues to be a bipartisan effort to focus on value, rather than volume, Ms. McCann continued."There are many who would like to get rid of fee-for-service in the Medicare system altogether," she said. Ms. McCann also pointed out that three codes are under scrutiny by the Cen- ters for Medicare and Medicaid Serv- ices and were recently reviewed by the American Medical Association Relative Value Scale Update Com- mittee. "No new money is coming into Medicare. If you want to in- crease the relative value, the money has to come from somewhere else. The work values are based on time and intensity, and in this way, we are victims of our own success. As we become more efficient and have greater outcomes, we are penalized." EW Editors' note: Ms. McCann has no financial interests related to her talk. Contact information McCann: nmccann@ascrs.org Correction to the January Issue In the January issue of EyeWorld, Dr. Keith Warren was misidentified as the current Chairman of the Department of Ophthalmology at the University of Kansas School of Medicine. At the time of publication, Dr. Warren was no longer affiliated with the University of Kansas or the Department of Ophthalmology. © 2011 Novartis 11/11 ALL11498JAD-PI