MAR 2014

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

Issue link: https://digital.eyeworld.org/i/276058

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Page 20 of 210

E W NEWS & OPINION 18 Refractive errors perhaps not as common, but other problems may arise more frequently A n eye exam is typically part of the evaluations that a school-aged child newly diagnosed with attention deficit/hyperac- tivity (ADD/ADHD) disorder may re- c eive. However, the exact prevalence of visual problems in children with ADD/ADHD remains in question. The latest published study, from the October 2013 issue of the Journal of the American Association of P ediatric Ophthalmology and Strabismus, found no significant difference in refractive errors when comparing children who have ADD/ADHD with a control group. 1 The Israeli-based investigators recorded uncorrected visual acuity (UCVA) for distance and near, cyclo- plegic refraction, ocular motility, a nd binocular function for 56 chil- dren with ADD/ADHD and a control group of 66 children. The majority of the patients in both groups were boys, and the mean subject age was 9.5 years and 9 years, respectively. Investigators found an average UCVA of about 20/20 for distance and J1 for near in both study groups. B oth groups had similar binocular function and accommodation, with the exception of a significant differ- ence in the near point of conver- gence in the control subjects compared with those with ADD/ ADHD. They found a cycloplegic spherical equivalent of +0.89 D in the control group and +0.63 D in the ADD/ADHD group. Previous studies have linked convergence insufficiency with ADD/ADHD, but the only inci- dences found in this study were in two children with borderline values. Investigators did not find any difference in clinical parameters for subjects on ADD/ADHD medications (who comprised 27% of the group) versus those who were not using the medications. "Our hypothesis of an associa- tion of ADD/ADHD with undiag- nosed hyperopia or astigmatism was not supported by the study data," the investigators wrote. Some study limitations include possible undiagnosed ADD/ADHD in the control group and possible ex- aminer bias, as the examiner was only partially masked regarding which children were in each group, the investigators reported. Squaring results with previous research The recently published study takes its place among research that has yet to provide conclusive answers—al- though the available studies do seem to point to some role for a greater incidence of visual abnormalities in children with ADD/ADHD. A 2012 study led by Eedy Mezer, MD, head of pediatric ophthalmology and strabismus, March 2014 by Vanessa Caceres EyeWorld Contributing Writer Pinpointing eye problems in children with ADD/ADHD BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE I LEVRO™ Suspension is indicated for the treatment of pain and in ammation a ssociated with cataract surgery. DOSAGE AND ADMINISTRATION Recommended Dosing One drop of ILEVRO™ Suspension should be applied to the a ected eye one-time-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the rst 2 weeks of the postoperative period. An additional drop should be administered 30 to 120 minutes prior to surgery. Use with Other Topical Ophthalmic Medications ILEVRO™ Suspension may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. CONTRAINDICATIONS ILEVRO™ Suspension is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAIDs. WARNINGS AND PRECAUTIONS Increased Bleeding Time With some nonsteroidal anti-in ammatory drugs including ILEVRO™ Suspension, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-in ammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that ILEVRO™ Suspension be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Delayed Healing Topical nonsteroidal anti-in ammatory drugs (NSAIDs) including ILEVRO™ Suspension, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Corneal E ects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including ILEVRO™ Suspension and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk and severity of corneal adverse events. Contact Lens Wear ILEVRO™ Suspension should not be administered while using contact lenses. ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not re ect the rates observed in practice. Ocular Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These events occurred in approximately 5 to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Some of these events may be the consequence of the cataract surgical procedure. Non‐Ocular Adverse Reactions Non‐ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic E ects. Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. At this dose, the animal plasma exposure to nepafenac and amfenac was approximately 70 and 630 times human plasma exposure at the recommended h uman topical ophthalmic dose for rats and 20 and 180 times human plasma e xposure for rabbits, respectively. In rats, maternally toxic doses ≥10 mg/kg w ere associated with dystocia, increased postimplantation loss, reduced fetal w eights and growth, and reduced fetal survival. Nepafenac has been shown to cross the placental barrier in rats. There are no adequate and well‐controlled studies in pregnant women. Because animal r eproduction studies are not always predictive of human response, ILEVRO™ Suspension should be used during pregnancy only if the potential bene t j usti es the potential risk to the fetus. Non‐teratogenic E ects. Because of the known e ects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ILEVRO™ Suspension during late pregnancy should be avoided. Nursing Mothers ILEVRO™ Suspension is excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ILEVRO™ Suspension is administered to a nursing woman. Pediatric Use T he safety and e ectiveness of ILEVRO™ Suspension in pediatric patients below the age of 10 years have not been established. Geriatric Use No overall di erences in safety and e ectiveness have been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Nepafenac has not been evaluated in long‐term carcinogenicity studies. Increased chromosomal aberrations were observed in Chinese hamster ovary cells exposed in vitro to nepafenac suspension. Nepafenac was not mutagenic in the Ames assay or in the mouse lymphoma forward mutation assay. Oral doses up to 5,000 mg/kg did not result in an increase in the formation of micronucleated polychromatic erythrocytes in vivo in the mouse micronucleus assay in the bone marrow of mice. Nepafenac did not impair fertility when administered orally to male and female rats at 3 mg/kg. PATIENT COUNSELING INFORMATION Slow or Delayed Healing Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti‐in ammatory drugs (NSAIDs). Avoiding Contamination of the Product Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery. Contact Lens Wear ILEVRO™ Suspension should not be administered while wearing contact lenses. Intercurrent Ocular Conditions Patients should be advised that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of the multi‐dose container. Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. Shake Well Before Use Patients should be instructed to shake well before each use. U.S. Patent Nos. 5,475,034; 6,403,609; and 7,169,767. ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2013 Novartis 2/13 ILV13030JAD 84280 ILV13030JAD PI EW indd 1 12/11/13 1:25 PM 18-47 News_EW March 2014-DL2 copy_Layout 1 3/7/14 9:03 AM Page 18

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