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EW NEWS & OPINION 20 March 2016 patient's high astigmatism. Because of his rosacea, he may not be a good candidate for a rigid gas permeable lens. However, if his corneal thick- ness is sufficient, PRK to correct some of his astigmatism at a later point could be considered after treating his ocular surface disease. In that case, I would target more myopia with the IOL so the excimer treatment would remove less tissue down the road. Since he is on chron- ic timolol (I do think all chronic BAK products can exacerbate ocular surface disease), I would also consid- er an iStent [Glaukos, Laguna Hills, Calif.] implantation at the time of surgery." Michael Snyder, MD, Cincin- nati, noted, "While there is some irregularity on topography, the central rings of the Placido image actually look pretty regular. Given the compact corneal stroma, even though there is some corneal haze, I would be inclined to preserve native anatomy as much as is reasonably possible. Slit lamp haze can often look more impressive than its visual impact, and the Haab's striae have been present life-long. Also, given the 1-eyed nature of this patient, I think a tiered approach may be preferable because sometimes less is more. I would favor cataract sur- gery alone with a toric IOL in the highest available power. Given the buphthalmic globe, I fully expect to find a large capsular bag and, likely, loose zonules. I would plan to place a type 1-L Cionni ring in the bag and secure it to the scleral wall with GORE-TEX sutures. As the bag will likely be bigger than the ring diam- eter, one can mechanically increase the diameter of the PMMA ring by slightly 'bending' it outward a bit in many locations. It will cover only 270 degrees of capsule equator in such a case, thus an Ahmed type 6-E segment will be required to support the open 90 degrees. Since the bag will be too big to ensure centration or stability of the toric IOL, a prima- ry posterior capsulorhexis should be performed (prior to CTR placement) about 4.5 mm in diameter. After the CTR has been placed and secured, the PCIOL can be placed within the capsular bag and rotated into posi- tion, and the axis can be confirmed and the optic captured into Berger's space through the PCCC, locking it from rotation and guaranteeing centration. If this achieves all goals, then we are done. If not, sequential DMEK then perhaps DALK can be considered until 'happy' has been achieved." astigmatism. Moreover, in this highly unusual eye, positioning of a toric IOL might be problematic due to issues with an excessively large capsule and/or weak zonules, so I would avoid the temptation to be a hero by trying to treat the astigma- tism. Given his monocular status, he needs to wear glasses for safety reasons in any case so correction of astigmatism is of secondary impor- tance. The thickened Descemet's membrane is unusual. The history makes no mention of guttata, but one of the slit lamp images shows a suggestion of guttata. Extra atten- tion needs to be paid to informed consent, particularly with regard to retinal detachment risk as well as the possible need for lamellar corne- al transplantation after surgery. "I would proceed with cataract surgery under topical anesthesia with an aspheric, single-piece intra- ocular lens [Softec HD, Lenstec, St. Petersburg, Fla.]. This lens has zero asphericity, so in case it should de- center, there would be fewer induced aberrations postoperatively. This is a young (55-year-old) patient so the lens is likely relatively soft. Using copious amounts of dispersive visco- elastic, there is an excellent chance that cataract surgery can be per- formed without further compromis- ing his cornea. I would try to avoid doing a combined cataract/DSAEK procedure because of the increased risk of complications, but should his cornea decompensate afterward, I would proceed with DSEK." David Goldman, MD, Palm Beach, Fla., commented, "This 55-year-old CEO presents with mul- tiple ocular issues and, to top it off, is monocular. In addition, the eye is abnormally large, not only with a history of retinal detachment but congenital glaucoma with loss of the other eye. This is a high functioning VIP who needs restoration of his vi- sion as soon as possible. While a to- ric lens can be implanted, several is- sues arise. To begin, even the highest correction T9 IOL will only correct about half of his astigmatism. That said, he is likely to have a very large bag with possible zonular weakness. As his cornea/globe is rather large, there is a chance that even when fully opened the toric IOL may spin around like a pinwheel. An air or gas bubble from a simultaneous DSAEK/ DMEK procedure may further rotate the IOL. The cornea and lens pro- cedures could be split, but now you have left the CEO effectively blind for at least several weeks. If he were motivated and understanding, I may consider a T9 implant followed by secondary DSAEK. However, in a patient like this I think the best procedure is to combine cornea and lens procedures at the same time. The most conservative approach would be a combined CE/IOL (monofocal IOL) and DSAEK. I've done this several times, targeting about –1.25 to end with effective plano refraction after the corneal induced hyperopic shift. Unfortu- nately, that does not account for the show some irregularities consistent with dry eye. I've found that a short course of oral azithromycin 500 mg PO x 5 days does wonders for rosacea, and I would also treat the rosacea with an antibiotic steroid combination drop, warm compress- es, and aggressive lubrication of the ocular surface before cataract surgery. "There is no implant available in the U.S. that can treat 8 D of Big continued from page 19 continued on page 22 RESTASIS ® (Cyclosporine Ophthalmic Emulsion) 0.05% BRIEF SUMMARY—PLEASE SEE THE RESTASIS ® PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION. INDICATION AND USAGE RESTASIS ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. CONTRAINDICATIONS RESTASIS ® is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. WARNINGS AND PRECAUTIONS Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, be careful not to touch the vial tip to your eye or other surfaces. Use with Contact Lenses RESTASIS ® should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS ® ophthalmic emulsion. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, the most common adverse reaction following the use of RESTASIS ® was ocular burning (17%). Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring). Post-marketing Experience The following adverse reactions have been identified during post approval use of RESTASIS ® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration). USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C Adverse effects were seen in reproduction studies in rats and rabbits only at dose levels toxic to dams. At toxic doses (rats at 30 mg/kg/day and rabbits at 100 mg/kg/day), cyclosporine oral solution, USP, was embryo- and fetotoxic as indicated by increased pre- and postnatal mortality and reduced fetal weight together with related skeletal retardations. These doses are 5,000 and 32,000 times greater (normalized to body surface area), respectively, than the daily human dose of one drop (approximately 28 mcL) of 0.05% RESTASIS ® twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively, during organogenesis. These doses in rats and rabbits are approximately 3,000 and 10,000 times greater (normalized to body surface area), respectively, than the daily human dose. Offspring of rats receiving a 45 mg/kg/day oral dose of cyclosporine from Day 15 of pregnancy until Day 21 postpartum, a maternally toxic level, exhibited an increase in postnatal mortality; this dose is 7,000 times greater than the daily human topical dose (0.001 mg/kg/day) normalized to body surface area assuming that the entire dose is absorbed. No adverse events were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily human dose). There are no adequate and well-controlled studies of RESTASIS ® in pregnant women. RESTASIS ® should be administered to a pregnant woman only if clearly needed. Nursing Mothers Cyclosporine is known to be excreted in human milk following systemic administration, but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of RESTASIS ® ophthalmic emulsion, caution should be exercised when RESTASIS ® is administered to a nursing woman. Pediatric Use The safety and efficacy of RESTASIS ® ophthalmic emulsion have not been established in pediatric patients below the age of 16. Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Systemic carcinogenicity studies were carried out in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value. In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate in the low-dose level. The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 80 times greater (normalized to body surface area) than the daily human dose of one drop (approximately 28 mcL) of 0.05% RESTASIS ® twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Mutagenesis: Cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA- repair test in sperm from treated mice. A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes in vitro gave indication of a positive effect (i.e., induction of SCE). Impairment of Fertility: No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 2,000 times the human daily dose of 0.001 mg/kg/day normalized to body surface area) for 9 weeks (male) and 2 weeks (female) prior to mating. PATIENT COUNSELING INFORMATION Handling the Container Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. To avoid the potential for injury to the eye, advise patients to not touch the vial tip to their eye. Use with Contact Lenses RESTASIS ® should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. Advise patients that if contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS ® ophthalmic emulsion. Administration Advise patients that the emulsion from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration. Rx Only Based on package insert 71876US18 © 2014 Allergan, Inc. Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. APC21XT14 Patented. See www.allergan.com/products/patent_notices Made in the U.S.A. Eyeworld

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