APR 2013

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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Page 10 of 82

April 2013 ASCRS continued from page 3 Important Safety Information – TECNIS® Multifocal IOL Caution: Federal law restricts this device to sale by or on the order of a physician. Indications: TECNIS® Multifocal intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag. Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low-illumination conditions. On rare occasions, these visual effects may be significant enough that the patient will request removal of the multifocal IOL. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens compared with a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night or in poor-visibility conditions. Patients with a predicted postoperative astigmatism >1.0D may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. Precautions: The central one millimeter area of the lens creates a far image focus; therefore, patients with abnormally small pupils (~1 mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements, as two different wavefronts are produced (one will be in focus (either far or near) and the other will be out of focus); therefore, incorrect interpretation of the wavefront measurements is possible. The long-term effects of intraocular lens implantation have not been determined; therefore, implant patients should be monitored postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or at temperatures over 45°C. Emmetropia should be targeted, as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration. Adverse events: The most frequently reported adverse event that occurred during the clinical trial of the TECNIS® Multifocal lens was macular edema, which occurred at a rate of 2.6%. Other reported reactions, occurring in 0.3% –1.2% of patients, were hypopyon, endophthalmitis and secondary surgical intervention (including biometry error, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning and patient dissatisfaction). Attention: Reference the Directions for Use for a complete listing of indications, warnings and precautions. 2011.12.14-CT4390 cal Committee and ASCRS TASS Task Force and is meant to provide guidance for ophthalmic surgeons seeking alternatives. Anecdotal reports have suggested that 1:1000 (1 mg/mL) epinephrine containing bisulfate appears to be safe when diluted at least 1:4 in BSS or BSS Plus.8 Several members of the Cataract Clinical Committee anecdotally report no adverse complications from regular use of direct intracameral injections of bisulfitecontaining epinephrine at a 1:4 dilution (e.g., 0.6 mL of BSS added to 0.2 mL of epinephrine). Likewise, the Cataract Clinical Committee believes that adding bisulfite-containing epinephrine to a 500 mL BSS irrigation bottle (offlabel) should not cause corneal endothelial toxicity because of the significant dilution. However, shortages of even bisulfite-containing 1:1000 epinephrine are now being reported in the United States. Three committee members (David F. Chang, MD, Gary Foster, MD, and Thomas A. Oetting, MD) report an increased incidence of IFIS despite the absence of systemic alpha antagonists when epinephrine is omitted from the BSS irrigation bottle. Several publications report the efficacy and safety of unpreserved 1.5% intracameral phenylephrine for both IFIS prevention and routine surgical mydriasis.9-12 One of these studies failed to find any significant reduction in endothelial cell counts compared with cell counts in untreated eyes.12 Preservative-free phenylephrine 2.5% (Minims) is only commercially available outside the United States. Because these preparations still contain bisulfite, a 1:4 dilution with BSS, BSS Plus, or preservative-free lidocaine is also recommended. Lacking a commercial source in the United States, several Cataract Clinical Committee members are using preservative-free and bisulfitefree intracameral phenylephrine 1.5% prepared by compounding pharmacies. To avoid potential toxicity from preservative-containing phenylephrine, ophthalmologists should specify that only the unpreserved (raw) drug should be used as a compounding source. Prudent precautions for any drug compounded for intracameral injection should include appropriate testing for pH, osmolality, and sterility. Ophthalmologists should consider requesting a "certificate of sterility" for any new intracameral preparation and should check to see whether the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Intracameral use of any alpha agonist is considered off-label. The recent commercial shortages of both the bisulfite-free and the bisulfitecontaining product have created significant concerns for surgeons who rely on intracameral epinephrine for established clinical indications. It is the consensus opinion and experience of the Cataract Clinical Committee that the preparations described in this report are clinically effective and appear to be safe when properly formulated. EW References 1. Shugar, JK. Intracameral Epinephrine for Prophylaxis of IFIS [letter]. J Cataract Refract Surg 2006; 32: 1074-1075. 2. Chang DF, Braga-Mele R, Mamalis N, Masket S, Miller KM, Nichamin LD, Packard RB, Packer M. ASCRS Cataract Clinical Committee. Clinical experience with intraoperative floppy-iris syndrome. Results of the 2008 ASCRS member survey. J Cataract Refract Surg 2008; 34:1201-1209. 3. Chang DF, Braga-Mele R, Mamalis N, Masket S, Miller KM, Nichamin LD, Packard RB, Packer M. ASCRS Cataract Clinical Committee. ASCRS White Paper: Clinical review of intraoperative floppy iris syndrome. J Cataract Refract Surg 2008; 34:2153-2162. 4. Hull DS, Chemotti MT, Edelhauser HF, Van Horn DL, Hyndiuk RA. Effect of epinephrine on corneal endothelium. Am J Ophthalmol 1975; 79:245-250. 5. Edelhauser HF, Hyndiuk RA, Zeeb A, Schultz RO. Corneal edema and the intraocular use of epinephrine. Am J Ophthalmol 1982; 93:327-333. 6. Slack JW, Edelhauser HF, Helenek MJ. A bisulfitefree intraocular epinephrine solution. Am J Ophthalmol 1990; 110: 77-82. 7. Gonnering R, Edehauser HF, Vanhorn DL, Durant W. The pH balance of rabbit and human corneal endothelium. Invest Ophthalmol Vis Sci 1979; 18:373390. 8. Myers WG, Edelhauser HF. Shortage of bisulfitefree preservative-free epinephrine for intracameral use. J Cataract Refract Surg 2011; 37:611. 9. Lundberg B, Behndig A. Intracameral mydriatics in phacoemulsification cataract surgery. J Cataract Refract Surg 2003; 29:2366-2371. 10. Gurbaxani A, Packard R. Intracameral phenylephrine to prevent floppy iris syndrome during cataract surgery in patients on tamsulosin. Eye 2007; 21:331-332. 11. Behndig A, Lundberg B. Mydriatic response to different concentrations of intracameral phenylephrine in humans. J Cataract Refract Surg. 2010;36:1682-1686. 12. Lorente R, DeRojs V, Vazquez DE, Targa P, Moreno C, Varella J, Landaluce ML, Mendez J, Lorente B. Intracameral phenylephrine 1.5% for prophylaxis against intraoperative floppy iris syndrome: prospective, randomized fellow eye study. Ophthalmology 2012; 119:2053-2058. Contact information Sebrell: csebrell@ascrs.org

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