Eyeworld

March 2011 Femtosecond technique outperforms manual maneuvers F or patients with anterior corneal pathology, a fem- tosecond laser-assisted su- tureless anterior lamellar keratoplasty (FALK) rapidly improves vision with no significant induced astigmatism, according to Sonia H. Yoo, M.D., associate pro- fessor of clinical ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami. In the September 2010 e-edi- tion of Ophthalmology, investigators reported that with the femtosecond approach, 83% of patients with an- terior corneal pathology achieved within two lines of their best specta- cle-corrected vision at just 5 weeks after surgery. The idea to use the femtosecond approach was a natural outgrowth of previous techniques, which had fallen short. "One of the limitations of anterior lamellar keratoplasty in the past has been our inability to perfectly match the donor tissue to the tissue that has been resected from the participant," Dr. Yoo said. Initially the tissue was resected by hand; when microkeratomes entered the picture they were used to assist with the procedure. "The problem with the microkeratomes is that we still had some mismatch between the donor and the recipient," Dr. Yoo said. "That's why we thought about using the femtosecond laser." Sutureless surgery Included in the retrospective case study were 13 consecutive patients who underwent femtosecond laser- assisted anterior lamellar kerato- plasty for anterior corneal pathologies. "We wanted to do the procedure without using sutures, so we looked at patients who had at least 250 microns of residual stromal bed once the scar was removed," Dr. Yoo said. She sees the use of a su- tureless approach as vital here. "One of the limitations of keratoplasty is that although we can get a clear cornea, patients often have high astigmatism and high differences in refractive errors between the two eyes even though the opacity is gone," Dr. Yoo said. "It's not an un- common scenario for the doctor to be happy because the cornea is clear but the patient to be unhappy be- cause he or she still can't function." As a result, Dr. Yoo sees a sutureless approach as not only increasing the rate of visual rehabilitation but also decreasing the amount of induced astigmatism and other problems such as infection and graft rejection. Dr. Yoo was encouraged by the results with the femtosecond ap- proach. "Our best spectacle-cor- rected vision seemed like it was significantly improved when com- pared to the pre-operative values; that improvement was stable be- tween the 6-month and the last visit," she said. The numbers were very promis- ing. "At 18 months, 50% of the eyes achieved best corrected vision of better than 20/30, and at 36 months 60% of the eyes achieved best spec- tacle-corrected vision of better than 20/30," Dr. Yoo said. Complications with the fem- tosecond approach were minimal. "The biggest complication was resid- ual stromal scar. We were going to leave at least a reasonable residual stromal bed so that there wouldn't be any risk of ectasia, and we weren't putting in any stitches," she said. "Seven of the eyes had some residual scarring in the interface; for two of these eyes we went back and did some PTK underneath the bed." In terms of refraction, it remained stable following the procedure. "The pre-operative spherical equivalent was –1.7 D. There was no significant change to this post-op and it re- mained stable over time," Dr. Yoo said. by Maxine Lipner Senior EyeWorld Contributing Editor FALK procedure spot-on for treating corneal pathology RESTASIS ® (cyclosporine ophthalmic emulsion) 0.05% Sterile, Preservative-Free INDICATIONS 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 active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. WARNING RESTASIS ® ophthalmic emulsion has not been studied in patients with a history of herpes keratitis. PRECAUTIONS General: For ophthalmic use only. Information for Patients 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. Do not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. RESTASIS ® should not be administered while wearing contact lenses. Patients with decreased tear produc tion 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. Carcinogenesis, Mutagenesis, and Impairment of Fertility 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 1000 and 500 times greater, respectively, than the daily human dose of one drop (28 µL) of 0.05% RESTASIS ® BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Cyclosporine has not been found mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronu cleus 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). 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 15,000 times the human daily dose of 0.001 mg/kg/day) for 9 weeks (male) and 2 weeks (female) prior to mating. Pregnancy-Teratogenic Effects Pregnancy category C. Teratogenic Effects: No evidence of teratogenicity was observed in rats or rabbits receiving oral doses of cyclosporine up to 300 mg/ kg/day during organogenesis. These doses in rats and rabbits are approximately 300,000 times greater than the daily human dose of one drop (28 µL) 0.05% RESTASIS ® BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Non-Teratogenic Effects: 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 30,000 and 100,000 times greater, respectively than the daily human dose of one-drop (28 µL) of 0.05% RESTASIS ® BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal tox icity 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 17,000 and 30,000 times greater, 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 post partum, a maternally toxic level, exhibited an increase in postnatal mortality; this dose is 45,000 times greater than the daily human topical dose, 0.001 mg/kg/day, assuming that the entire dose is absorbed. No adverse events were observed at oral doses up to 15 mg/kg/day (15,000 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. ADVERSE REACTIONS The most common adverse event following the use of RESTASIS ® was ocular burning (17%). Other events 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). Rx Only Based on package insert 71876US14B Revised February 2010 ©2010 Allergan, Inc. Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. APC80OW11 U.S. Patent 5,474,979 Made in the U.S.A. 315-25995 Bleed: XX.XX" x XX.XX" Trim: 2.125" x 12.5" Live: XX.XX" x XX.XX" CLIENT NAME: Abelson Taylor JOB#: VW120 DESC: Restasis OPERATOR: DL ROUND: 1 DATE: 02/14/2011 FILE NAME: VW120_b01.indd QC Check __________ __________ __________ Pre- and post-FALK photos of a corneal scar Source: Sonia H. Yoo, M.D. continued on page 76

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