EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/119916
AcrySof® IQ ReSTOR® IOL Important Safety Information CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. Clinical studies with the AcrySof® ReSTOR® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. AcrySof® IQ IOL Important Safety Information CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof® IQ posterior chamber intraocular lens is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. AcrySof IQ Toric IOL Important Safety Information ® CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof® IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision. WARNING/PRECAUTION: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens; residual viscoelastics may allow the lens to rotate. Optical theory suggests that high astigmatic patients (i.e. > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ Toric Cylinder Power IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. © 2013 Novartis 1/13 ACR13008JAD February 2011 Dry eye/ocular surface April 2013 New continued from page 42 Zioptan has none. There have been a lot of studies about the effects of preservatives, so minimizing preservative contact in a less frequent dosing regime is ideal," he said. Whether the drug proves to be as efficacious remains to be seen over time, he said, but it does appear to be the start of a new trend in glaucoma medication. Omega-3s Dry eye patients also have specific issues related to pharmaceuticals and the ocular surface. Dr. Donnenfeld said that medications that enhance the ocular surface through non-preservation and the ability to improve the tear film quality are vital to those patients. He said the prototype topical medication in those cases has been Restasis (cyclosporine, Allergan, Irvine, Calif.). Other topical medications that are important for dry eye are some of the new tear formulations. For oral medications, a supplement of choice and importance is the new triglyceride forms of omega3s, he said. "Over the last decade, we've realized that the single thing that we can do as clinicians that helps our patients' ocular surface, prevents macular degeneration, improves dry eye and meibomian gland dysfunction, as well as has tremendous systemic side effects of lowering cholesterol, improving arthritis, and there is some evidence that it reduces Alzheimer's disease and cardiac death, is use omega-3 fish oil," Dr. Donnenfeld said. He said alcohol is used in many omega-3 formulations to remove contaminants in fish. He emphasized that triglyceride formulations without alcohol added, such as Physician Recommended Nutriceuticals (PRN, Plymouth Meeting, Pa.), have the most nutritional benefits. "In [adding alcohol], it converts the natural triglyceride into an unnatural state called an ethyl ester. Ethyl esters are not found in nature and our bodies have problems processing them, which is why they have poor absorption," he said. "So when you take an omega-3 that you buy in a health food store that has had alcohol added to it, you're basically getting the equivalent of white bread." Gel Another new drug formulation that appears to be beneficial to dry eye patients is loteprednol etabonate (Lotemax, Bausch + Lomb, Rochester, N.Y.). Dr. Donnenfeld said he thinks this new formulation could be important. "It has a unique vehicle that allows it to stay on the ocular surface and provide anti-inflammatory therapy while providing a coating of the ocular surface that prevents drying. It's a wonderful combination of immunomodulators to use with Restasis. I use loteprednol gel, and because it's a gel, it stays in the eye for longer periods of time, and it sticks to the lid," he said. Dr. Lindstrom said Lotemax, in its strengthened form, should be familiar to ophthalmologists. The drug is indicated for the treatment of ocular inflammation after cataract surgery, and its use for ocular surface disease is an off-label indication. It is often commonly used for the treatment of dry eye and ocular allergies, both off-label as well, he said. "It also treats meibomian gland dysfunction so you get a lot of antiinflammatory effect on the lid margin. I think that's an exciting new product for treating lid disease and dry eye," Dr. Donnenfeld said. NSAID A new formulation of a nonsteroidal anti-inflammatory drug (NSAID), nepafenac (Ilevro, Alcon, Fort Worth, Texas), is a good addition to the surgical armamentarium of ocular surface-friendly pharmaceuticals in several ways, said Edward J. Holland, MD, professor of ophthalmology, University of Cincinnati, and director, cornea service, Cincinnati Eye Institute, Cincinnati. First, the concentration was changed from 0.1% to 0.3%, which reduced the dosing frequency from three times a day to once a day. Clinical trials on efficacy and a head-to-head study against Nevanac (nepafenac, Alcon) showed noninferiority, Dr. Holland said. "A once-a-day drop of 0.3% Ilevro was equal to three times a day of 0.1% Nevanac," he said. He said that in post-cataract surgery or post-PRK patients, the total number of drops is significantly reduced when compared to others with this formulation. "If this patient has ocular surface disease, that's a significant reduction of potential toxicity because we know that all NSAIDs can have some side effects on the ocular surface," Dr. Holland said. "Same thing with the PRK patient. We like using NSAIDs in those patients because it can reduce postoperative pain and improve the patient's experience. NSAIDs can slow epithelium healing, so if we can reduce the frequency from three times a day to once a day, we're going to show less irritation to the surface." In addition, Alcon added moisturizing agents, including guar gum, to the formulation. This has increased the drop's viscosity, rendering it friendlier to the ocular surface, he said. EW Editors' note: Dr. Donnenfeld has financial interests with Bausch + Lomb, PRN, and Alcon. Dr. Holland has financial interests with Alcon. Dr. Lewis has financial interests with Alcon, Allergan, and Merck. Dr. Lindstrom has financial interests with Alcon, Abbott Medical Optics (AMO, Santa Ana, Calif.), and Bausch + Lomb. Contact information Donnenfeld: 516-446-3525, ericdonnenfeld@gmail.com Holland: 859-331-9000, eholland@holprovision.com Lewis: 916-649-1515, rlewiseyemd@yahoo.com Lindstrom: 612-813-3633, rllindstrom@mneye.com EyeWorld @EWNews Follow EyeWorld on Twitter at twitter.com/EWNews Find us on social media Are you a fan of EyeWorld? Like us on Facebook at facebook.com/EyeWorldMagazine