EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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4 EW NEWS & OPINION Alliance continued from page 3 "IPAB flies in the face of ac- countable democracies," Mr. Yehl said, adding that hospitals and long- term care facilities are excluded from IPAB Medicare cuts that will take place in 2020. "The cuts come on the backs of the providers, which is grossly unfair," he said. The Medicare Patient Empower- ment Act would allow patients to contract with physicians for 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 Medicare services as well as allow physicians to bill patients for services that aren't covered under Medicare. Sen. Rand Paul, M.D. (R-KY), echoed many sentiments about the SGR. "The whole formula makes no sense at all," he said, adding that he supports changing the Medicare enrollment age to 70 and putting recipients on the Congressional 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 healthcare plan, which is 75% subsi- dized. Sandra Yeh, M.D., Springfield, Ill., a member of the ASCRS Govern- ment Relations Committee, told the panel that Congress is experiment- ing with Medicare. "It's a total radical change that there's no real proof at the end of savings," she said about recent healthcare changes. Several lawmakers spoke out against the ACA and components of it. Rep. Tom Price, M.D. (R-GA), called for a total repeal of the ACA and commented on the recent SCOTUS decision. "Just because it's constitutional doesn't mean it's good policy," Rep. Price said. The ACA is "destructive to the 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 health of individuals across this nation and also destructive to our economy." The SGR, too, needs to go, he said. "The formula is flawed. It's de- structive to what you do," he said. "It needs to be thrown out. We have to come out with a new model." CMS representative Michael Wroblewski gave a rundown of the value-based payment modifier (VBPM), the implementation of which the Alliance is asking for a delay from because of its focus on "arbitrary indicators of perform- ance." Mr. Wroblewski said the VBPM will adjust payments based on quality and cost. "In the budget-neutral value- based payment modifier, poor per- formers will fund high performers," he said. CMS will "reward high per- formers with payment adjustments. The vast middle will stay the same. The focus is on the outliers." For his part, R. Doyle Stulting, M.D., director, Corneal Disease and Research, Woolfson Eye Institute, Atlanta, called the CMS proposals "laughable." "This is another example of government sucking money out of healthcare that should be used for patient care," he said. Dr. Stulting said he was looking forward to giving legislators some insight into the problems that specialty physicians face. "Personal participation in the legislative process is the only way to have a voice in the way healthcare is delivered in the future," he said. EW Contact information Chang: dceye@earthlink.net Stulting: dstulting@woolfsoneye.com Yeh: syeh2020@aol.com See page 12 for photos from the Legislative Fly-In. August 2012 © 2011 Novartis 11/11 ALL11498JAD-PI