JAN 2013

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

Issue link: https://digital.eyeworld.org/i/104833

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January 2013 Important Safety Information–HEALON EndoCoat OVD ® INDICATIONS: HEALON EndoCoat OVD is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including: cataract surgery with an intraocular lens, cataract surgery without an intraocular lens, secondary intraocular lens implantation. HEALON EndoCoat OVD maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation. ® ® In the journal … January 2013 Prophylaxis for post-operative endophthalmitis Neal H. Shorstein, M.D., Kevin L. Winthrop, M.D., Lisa J. Herrinton, Ph.D. The aim here was to consider the impact of changing antibiotic practice patterns on post-cataract endophthalmitis rates for the period between 2007 and 2011. The first critical time period considered was 2007 when the practice was to administer antibiotic drops post-operatively without intracameral injection. For the 2008 and 2009 time period, the practice was to augment a topical drop regimen with intracameral cefuroxime where possible. In the most recent 2010 and 2011 period, the pattern was for practitioners to administer an intracameral injection of cefuroxime, moxifloxacin, or vancomycin, with adjunctive topical antibiotic use left to the surgeon's discretion. For the 2007 time period, the mean endophthalmitis rate per 1,000 was determined to be 3.13. In the period from 2008 to 2009, this rate was at 1.43. Finally, in the period from 2010 to 2011, this was down to just 0.14. In instances when there was no posterior chamber rupture involved, the endophthalmitis rate for those strictly receiving an intracameral injection without topical antibiotics was just 0.49 per 1,000. Investigators concluded that the decline in the rate of post-operative endophthalmitis corresponded with the adoption of the practice of using intracameral antibiotic injection. They also found that use of intracameral injection alone resulted in a low endophthalmitis rate. IOP during laser-assisted cataract surgery using a fluid-filled interface Tim Schultz, M.D., Ina Conrad-Hengerer, M.D., Fritz H. Hengerer, M.D., H. Burkhard Dick, M.D. In this prospective clinical trial, investigators used a tonometer with a fluid-filled interface to measure IOP during femtosecond laser-assisted cataract surgery. Investigators found that the mean pre-operative IOP was 15.6 mm Hg. Mean IOP climbed to 25.9 mm Hg when the suction ring and vacuum was applied. The mean IOP then fell to 19.1 mm Hg when the suction ring was removed. Investigators found that by the one-hour post-surgical mark, when compared to pre-op values, IOP was not significantly different. They determined that with the fluid-filled interface there was a slight increase in IOP. However, this did not approach that found in the literature with flat and curved applanating contact interfaces, where substantially higher IOP rates were reported. Laboratory science: femtosecond laser capsulotomy stability Gerd U. Auffarth, M.D., Kasu Prasad Reddy, M.D., Roland Ritter, M.Sc., Mike P. Holzer, M.D., Tanja M. Rabsilber, M.D. In this study, performed using pig eyes, investigators measured and compared manual capsulotomies to those made with the femtosecond laser-assisted technique. They found that for capsulotomies made with the laser-assisted approach, the maximum amount of force recorded immediately before tissue ruptured was 113 millinewtons (mN) compared with just 22 mN when a manual procedure was used. They concluded that the anterior capsule opening was stronger when the capsulotomy was made with a femtosecond laser-assisted approach than with a standard manual technique. Updated continued from page 3 bursement pathways for the FS laser with Medicare beneficiaries. On Nov. 16, 2012, CMS issued additional guidance on when surgeons may bill consenting patients for use of the femtosecond laser at the time of cataract surgery. What is new is that patients receiving a toric or presbyopia-correcting IOL can be billed for the imaging component of the FS laser procedure, which the surgeon feels is necessary for the implanta- tion of these refractive IOLs. Apart from astigmatic keratotomy, which is non-covered, patients receiving monofocal IOLs may not be billed for using the FS laser for imaging or the cataract steps. The ASCRS/AAO FS laser billing guidelines were updated with this new information and are reprinted on page 3. EW CONTRAINDICATIONS: At present, there are no contraindications to the use of HEALON EndoCoat OVD when used as recommended. ® WARNINGS: The HEALON EndoCoat OVD Delivery system is not designed or intended to be attached to instruments other than the one provided with the product. Failure to follow the "Directions for Use" may result in cannula detachment. Mixing of quaternary ammonium salts, such as benzalkonium chloride, with sodium hyaluronate results in the formation of a precipitate. The eye should not be irrigated with any solution containing benzalkonium chloride if HEALON EndoCoat OVD is to be used during surgery. ® ® PRECAUTIONS: CAUTION: Injection of viscoelastics creates pressure in the syringe. To prevent expulsion of the cannula into the eye, ensure that the cannula is securely attached to the fitting on the syringe. Use of the cannula guard is recommended. CAUTION: The cannula should be fastened securely to the syringe; however, over tightening may cause the hub to weaken and possibly detach from the syringe. Extrusion of a test droplet is recommended prior to entering the eye, and excessive force on the plunger should be avoided. CAUTION: Do not reuse the cannula. This could release particulate matter. Product and cannula are for single use only. Re-use may cause eye inflammation. CAUTION: The potential for early and short-term postoperative intraocular pressure (IOP) spikes exists with dispersive OVDs, which potentially require more time and care to remove from the eye. Therefore, it is recommended that HEALON EndoCoat OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early postoperative IOP spikes. Observe the usual precautions taken during anterior segment surgery. Pre-existing glaucoma, the surgery itself, or retained viscoelastic (particularly in patients with compromised trabecular meshwork) can cause increased intraocular pressure after the procedure (1). ® The following precautions should be carefully considered: s 4HE INTRAOCULAR PRESSURE OF POSTOPERATIVE PATIENTS SHOULD BE CAREFULLY MONITORED particularly in the early postoperative period. s $O NOT USE EXCESSIVE AMOUNTS OF HEALON EndoCoat OVD. s 2EMOVE HEALON EndoCoat OVD completely from the anterior chamber at the end of the procedure. s #ORRECTIVE THERAPY SHOULD BE INITIATED IF THE POSTOPERATIVE INTRAOCULAR PRESSURE rises above safe levels. s &OR INTRAOCULAR USE ONLY s 3TORE AT ª# ª& s 0ROTECT FROM FREEZING s 0ROTECT FROM LIGHT s 5SE ONLY IF SOLUTION IS CLEAR s !VOID TRAPPING AIR BUBBLES s #ONTENTS ARE STERILE WHEN THE PACKAGE IS SEALED AND UNDAMAGED s 5SE ASEPTIC TECHNIQUE s $O NOT USE IN CASES OF KNOWN HYPERSENSITIVITY TO ANY OF THE INGREDIENTS IN THIS PRODUCT s 3EE PRODUCT EXPIRATION DATE ® ® HEALON EndoCoat OVD does not require refrigeration. If refrigerated, HEALON EndoCoat OVD should be allowed to attain room temperature prior to use. There have been isolated reports of diffuse particulates or haziness appearing after injection of viscoelastics into the eye. While such reports are infrequent and seldom associated with any effects on ocular tissue, the physician should be aware of this occurrence. If observed, the viscoelastic should be removed by irrigation and/or aspiration. HEALON EndoCoat OVD is derived from microbial fermentation by a purified proprietary process. Although precautions have been taken to make this device protein-free, it may contain trace amounts of protein. The physician should be aware of the potential allergic risks such as postoperative inflammation that can occur with injection of biological materials. ® ® ® 1. Miller D, Stegmann R. The use of Healon in intraocular lens implantation. Int Ophthalmol Clin. 1982;22(2):177-181. ® Contact information Chang: dceye@earthlink.net 2012.05.11-CT5257

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