Eyeworld

JUN 2012

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

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June 2012 EW NEWS & OPINION 19 "In my experience, once enough fibrosis sets in to Z the lens, it is going to be challenging to excise the lens without risk to the eye and capsule. For all my cases of Z syndrome, YAG plus corneal excimer refractive surgery has rehabilitated the patients to a functional level with adequate uncorrected distance visual acuity and a few with slight myopia." Dr. Khodabakhsh said, "This is a much tougher case than case 1. This patient has a very long eye and is at risk for developing posterior seg- ment complications with significant lens manipulation. After 1 year, I tend to be much more conservative in this type of patient. Both eyes have a fan-shaped striae pattern with dense PCO. There is dense fibrosis of the capsule to the optics. I continued on page 20 (TRYPAN BLUE OPHTHALMIC SOLUTION)VISIONBLUE TM Figure 7. Posterior slit beam no longer in Z configuration after YAG to PC BRIEF SUMMARY OF PRESCRIBING INFORMATION Indications and Usage VisionBlueTM 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. Figure 8. Case 2 day 1 slit lamp photo post-IOL exchange. Note remnant of superior plate left behind and relative clarity of posterior capsule compared to pre-op (Figure 3) 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. Figure 9. Case 3 after YAG to break the "bridge" under the nasal hinge connecting the two previous YAG treatments herniation given the gap between the optic and the posterior capsule with nothing to tamponade the likely highly syneretic vitreous in this high myope and prevent it from herniating forward. I felt that vitre- ous in the anterior chamber would complicate further surgery that might be needed and increase the patient's risk of RD. Not all surgeons on the panel shared these concerns. Source (all): Steven G. Safran, M.D. Dr. Weinstock commented, "When I see this, my goal is to safely return the patient to functional vi- sion (hopefully without glasses) in the least traumatic or risky way pos- sible. This almost always means starting with YAG capsulotomy. The only time I would ever do surgical intervention first with attempted reposition or lens exchange is if it was seen in the first few weeks post- op. 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 is indicated for use as an aid in ophthalmic surgery by staining the anterior

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