SEP 2012

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

Issue link: https://digital.eyeworld.org/i/82503

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Page 19 of 103

20 EW NEWS & OPINION September 2012 ASCRS Best papers of session At the ASCRS•ASOA Symposium & Congress, the Best Paper of Session is selected by the moderator and panel for each free paper symposium. In the next several issues of EyeWorld, the medical editors will be highlighting some of these best papers by inviting the authors to submit a brief summary or abstract. —David F. Chang, M.D., chief medical editor VISIONBLUE capsule of the lens. Contraindications VisionBlueTM is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye because the dye may be absorbed by the IOL and stain the IOL. Precautions General: It is recommended that after injection all excess VisionBlueTM the eye by thorough irrigation of the anterior chamber. be immediately removed from Carcinogenesis, mutagenesis, impairment of fertility: Trypan blue is carcinogenic in rats. Wister/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total dose approximately 1,250,000-fold the maximum recommended human dose of 0.06 mg per injection in a 60 kg person, assuming total absorption). Trypan blue was mutagenic in the Ames test and caused DNA strand breaks in vitro. Pregnancy: Teratogenic Effects: Pregnancy Category C: Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/ kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. These doses are approximately 50,000- and 25,000-fold the maximum recommended human dose of 0.06 mg per injection based in a 60 kg person, assuming that the whole dose is completely absorbed. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality, and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 50,000-fold maximum recommended human dose of 0.06 mg per injection, assuming total absorption). There are no adequate and well-controlled studies in pregnant women. Trypan blue should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. Nursing mothers: 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 trypan blue is administered to a nursing woman. Pediatric use: The safety and effectiveness of trypan blue have been established in pediatric patients. Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients. Geriatric use: No overall differences in safety and effectiveness have been observed between elderly and younger patients. Adverse Reactions Adverse reactions reported following use of VisionBlueTM include discoloration of high water content hydrogen intraocular lenses (see Contraindications) and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week. Rx ONLY Revised: July 2005 Manufactured by: © Dutch Ophthalmic Research Center International b.v. Scheijdelveweg 2, 3214 VN Zuidland The Netherlands Distributed in the United States by: Dutch Ophthalmic USA 10 Continental Drive, Bldg 1 Exeter, NH 03833, U.S.A. Phone: 800-75-DUTCH or 603-778-6929 U.S. PAT. 6,367,480; 6,720,314 TM (TRYPAN BLUE OPHTHALMIC SOLUTION) BRIEF SUMMARY OF PRESCRIBING INFORMATION Indications and Usage VisionBlueTM is indicated for use as an aid in ophthalmic surgery by staining the anterior Glistenings and visual quality with two hydrophobic intraocular lenses Anish Dhital, M.R.C.Ophth., David J. Spalton, M.D., James F. Boyce, Ph.D. Glistenings are water vacuoles found within intraocular lens polymers. They are particularly common in some types of hydrophobic acrylic IOLs. Their effect on vision is controversial, but light scatter and contrast sensitivity are the factors most likely to be affected. We presented 1-year data from a prospective intra-individual study comparing two hydrophobic IOLs. The Xact IOL (Advanced Vision Sci- ence, Goleta, Calif.) is composed of a novel hydrophobic polymer with a high water content (4%), also used in the new enVista IOL (Bausch + Lomb, Rochester, N.Y.). This polymer has excellent optical char- acteristics and has been noted to be glistenings-free. The control IOL was the Acrysof SA60AT (Alcon, Fort Worth, Texas). A method of obtaining stan- dardized images of glistenings was developed. Custom software to objectively count glistenings from these images was developed with Dr. Boyce. Glistenings were graded using this objective system and clinically. Other measures included visual acuity, contrast sensitivity, PSF, and Strehl ratio. The Xact IOL was confirmed to be glistenings-free, whereas the control IOL had a 32% incidence of glistenings at 1 year. There were no significant differences in mean vision quality measures between the two groups at this time point. One patient noticed subjectively worse vision in the eye with glistenings, which corresponded to a slight drop in mesopic contrast sensitivity. Finally, the incidence of glistenings was unexpectedly found to be higher in Black and Asian patients. Intraoperative wavefront aberrometry for improved IOL power estimation: results of more than 4,500 cases Tsontcho Ianchulev, M.D., Kenneth J. Hoffer, M.D., Sonia H. Yoo, M.D. Dr. Ianchulev, inventor of the tech- nology for intraoperative refractive biometry, presented the clinical re- sults of more than 4,000 cases with the ORange device and the latest data from the next generation ORA wavefront aberrometry system by WaveTec Vision (Aliso Viejo, Calif.). Intraoperative aberrometry is an in- frared laser aberrometry system that attaches to any ophthalmic micro- scope and allows real-time refractive biometry of the eye during cataract surgery. It provides aphakic and astigmatic measurements to aid ac- curacy of IOL power calculation, LRI correction, and toric lens axis opti- mization. While ORange showed a slight trend for improved IOL power predictive accuracy over conven- tional pre-op biometry (78% vs. 75% within 0.5 D), the ORA device was clearly superior with more than 81% of eyes achieving refractive success within 0.5 D. More importantly, this accuracy is maintained for post- LASIK cases, where conventional methods have been challenged. EW

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