EyeWorld Asia-Pacific March 2013 Issue

21 EWAP CATARACT/IOL March 2013 hydrophilic IOL implantation. The DSAEK procedure was performed with intracameral injections of air in October 2010. “Two months later, the patient complained of ‘foggy’ vision,” Dr. Werner and co-investigators reported. “Opacification of the anterior surface of the IOL within the pupillary area was observed. As Nd:YAG laser disruption of the opacification was not successful, surgeons exchanged the IOL in October 2011.” Implications The easiest way to prevent this problem is to avoid hydrophilic acrylic lenses in patients where cataract surgery is needed concurrently or prior to DSEK or DSAEK. Surgeons should instead use hydrophobic lenses in those patients. “For the moment, surgeons should consider avoiding hydrophilic acrylic IOLs when procedures using intracameral air or gas are anticipated, particularly in DSEK or DSAEK,” Dr. Werner said. Generally speaking, surgeons in Europe use hydrophilic lenses more often, said Dr. Mamalis. However, even surgeons in the U.S. may have their personal preferences for the material, Dr. Lee said. In Dr. Lee’s office, some surgeons favor the use of hydrophilic acrylic lenses in routine cataract cases, and they work great in most cases—except for in two patients in whom the hydrophilic acrylic IOLs had to be explanted after endothelial keratoplasty procedures due to severe opacification and vision decline. In both cases the DSAEK was performed for advanced Fuchs’ dystrophy following prior cataract surgery. The IOL explantation occurred with the first year after the DSAEK procedures. IOL explantation under an endothelial graft carries a high risk for potential endothelial graft damage. “If a patient is going to have combined DSAEK and cataract removal, or if it is a patient with Fuchs’ dystrophy and you see moderate to advanced guttata, avoid hydrophilic acrylic lenses in those cases,” Dr. Lee said. “This is another thing to think about when you see patients with Fuchs’ dystrophy to avoid a potential serious complication.” However, this area requires further research, Dr. Werner believes. “Further investigation in this phenomenon is necessary to ascertain if the localized calcification is a result of direct contact between the IOL surface and the exogenous gas and air, of a metabolic change in the anterior chamber due to the presence of the exogenous gas and air, or the result of an exacerbated inflammatory reaction after multiple surgical procedures,” said Dr. Werner. EWAP Editors’ note: The physicians have no financial interests related to this article. Contact information Lee: 404-351-2220, lee0003@aol.com Mamalis: 801-581-6586, nick.mamalis@hsc.utah.edu Werner: 801-581-8136, liliana.werner@hsc.utah.edu A new - from page 19 TECNIS ® Monofocal Intraocular Lens (IOL) Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should ZHLJK WKH SRWHQWLDO ULVN EHQHÀW UDWLR SULRU WR LPSODQWLQJ D OHQV Precautions 'R QRW UHVWHULOL]H RU DXWRFODYH 8VH RQO\ VWHULOH irrigating solutions such as balanced salt solution or sterile normal VDOLQH 'R QRW VWRUH LQ GLUHFW VXQOLJKW RU LQ WHPSHUDWXUHV RYHU ƒ& Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece lens was PDFXODU HGHPD ZKLFK RFFXUUHG DW D UDWH RI 2WKHU UHSRUWHG UHDFWLRQV RFFXUULQJ LQ OHVV WKDQ RI SDWLHQWV ZHUH VHFRQGDU\ surgical intervention (pars plana vitrectomy with membrane peel) DQG OHQV H[FKDQJH GXH WR WRUQ OHQV KDSWLF TECNIS ® Multifocal 1-Piece Intraocular Lens (IOL) Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling VKRXOG ZHLJK WKH SRWHQWLDO ULVN EHQHÀW UDWLR SULRU WR LPSODQWLQJ D OHQV 6RPH YLVXDO HIIHFWV DVVRFLDWHG ZLWK PXOWLIRFDO ,2/V PD\ EH expected because of the superposition of focused and unfocused LPDJHV 7KHVH PD\ LQFOXGH D SHUFHSWLRQ RI KDORV JODUH DURXQG OLJKWV XQGHU QLJKWWLPH FRQGLWLRQV ,W LV H[SHFWHG WKDW LQ D VPDOO percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly LQ ORZ LOOXPLQDWLRQ FRQGLWLRQV 2Q UDUH RFFDVLRQV WKHVH YLVXDO HIIHFWV PD\ EH VLJQLÀFDQW HQRXJK WKDW WKH SDWLHQW ZLOO UHTXHVW UHPRYDO RI WKH PXOWLIRFDO ,2/ 8QGHU ORZ FRQWUDVW FRQGLWLRQV contrast sensitivity is reduced with a multifocal lens compared ZLWK D PRQRIRFDO OHQV 7KHUHIRUH SDWLHQWV ZLWK PXOWLIRFDO OHQVHV should exercise caution when driving at night or in poor-visibility FRQGLWLRQV 3DWLHQWV ZLWK D SUHGLFWHG SRVWRSHUDWLYH DVWLJPDWLVP ! ' PD\ QRW EH VXLWDEOH FDQGLGDWHV IRU PXOWLIRFDO ,2/ LPSODQWDWLRQ VLQFH WKH\ PD\ QRW IXOO\ EHQHÀW IURP D PXOWLIRFDO ,2/ LQ WHUPV RI SRWHQWLDO VSHFWDFOH LQGHSHQGHQFH &DUH VKRXOG be taken to achieve centration, as lens decentration may result in patients experiencing visual disturbances, particularly in patients ZLWK ODUJH SXSLOV XQGHU PHVRSLF FRQGLWLRQV Precautions: The central one millimeter area of the lens creates a far image focus; therefore, patients with abnormally small pupils (~1mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is XQFOHDU ZKHWKHU VXFK SDWLHQWV ZLOO GHULYH DQ\ QHDU YLVLRQ EHQHÀW Autorefractors may not provide optimal postoperative refraction of PXOWLIRFDO SDWLHQWV PDQXDO UHIUDFWLRQ LV VWURQJO\ UHFRPPHQGHG ,Q contact lens wearers, surgeons should establish corneal stability ZLWKRXW FRQWDFW OHQVHV SULRU WR GHWHUPLQLQJ ,2/ SRZHU &DUH should be taken when performing wavefront measurements, as two different wavefronts are produced (one will be in focus [either far or near], and the other will be out of focus); therefore, incorrect LQWHUSUHWDWLRQ RI WKH ZDYHIURQW PHDVXUHPHQWV LV SRVVLEOH 7KH ORQJ WHUP HIIHFWV RI ,2/ LPSODQWDWLRQ KDYH QRW EHHQ GHWHUPLQHG therefore, implant patients should be monitored postoperatively RQ D UHJXODU EDVLV 6HFRQGDU\ JODXFRPD KDV EHHQ UHSRUWHG occasionally in patients with controlled glaucoma who received OHQV LPSODQWV 7KH LQWUDRFXODU SUHVVXUH RI LPSODQW SDWLHQWV ZLWK JODXFRPD VKRXOG EH FDUHIXOO\ PRQLWRUHG SRVWRSHUDWLYHO\ 'R QRW UHVWHULOL]H RU DXWRFODYH 8VH RQO\ VWHULOH LUULJDWLQJ VROXWLRQV VXFK DV EDODQFHG VDOW VROXWLRQ RU VWHULOH QRUPDO VDOLQH 'R QRW VWRUH LQ GLUHFW VXQOLJKW RU LQ WHPSHUDWXUHV RYHU ƒ& (PPHWURSLD VKRXOG EH targeted, as this lens is designed for optimum visual performance ZKHQ HPPHWURSLD LV DFKLHYHG Adverse Events: The most frequently reported adverse event that occurred during the clinical WULDO RI WKH 7(&1,6 ® 0XOWLIRFDO ,2/ ZDV VXUJLFDO UHLQWHUYHQWLRQ ZKLFK RFFXUUHG DW D UDWH RI OHQV UHODWHG QRQ OHQV UHODWHG 6XUJLFDO UHLQWHUYHQWLRQ LQFOXGHG OHQV H[FKDQJH retinal repair, iris prolapse/wound repair, trabeculectomy, lens UHSRVLWLRQLQJ DQG OHQV UHPRYDO GXH WR SDWLHQW GLVVDWLVIDFWLRQ The second most frequent adverse event was macular edema, ZKLFK RFFXUUHG DW D UDWH RI 2WKHU UHSRUWHG UHDFWLRQV ZHUH K\SRS\RQ DQG HQGRSKWKDOPLWLV HDFK RFFXUULQJ DW D UDWH RI Caution: Federal law restricts these devices to sale by or on the RUGHU RI D SK\VLFLDQ 'R QRW XVH WKH OHQV LI WKH SDFNDJH KDV EHHQ GDPDJHG 7KH VWHULOLW\ RI WKH OHQV PD\ KDYH EHHQ FRPSURPLVHG Attention: Reference the Directions for Use labeling for a FRPSOHWH OLVWLQJ RI LQGLFDWLRQV ZDUQLQJV DQG SUHFDXWLRQV Important Safety Information &7