FEB 2014

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

Issue link: https://digital.eyeworld.org/i/274531

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Page 26 of 114

Important Product Information for the CENTURION® Vision System Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert® IOL Injector Handpiece does not perform as expected. Indication: The CENTURION® Vision system is indicated for emulsifcation, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualifed AcrySof® intraocular lenses into the eye following cataract removal. The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with the AcrySof® lenses SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifcally indicated for use with this inserter, as indicated in the approved labeling of those lenses. Warnings: Appropriate use of CENTURION® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low fow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufciently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in signifcant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage. Good clinical practice dictates the testing for adequate irrigation and aspiration fow prior to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation. The consumables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may afect system performance and create potential hazards. AEs/Complications: Inadvertent actuation of Prime or Tune while a handpiece is in the eye can create a hazardous condition that may result in patient injury. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip. ATTENTION: Refer to the Directions for Use and Operator's Manual for a complete listing of indications, warnings, cautions and notes. © 2014 Novartis 1/14 MIX14058JAD because it's influenced so much by cataract changes and might not be available or reliable when the vision is quite poor," Dr. Hoffer said. "On top of that, its influence is mini- mal." He said he tends to play down t he corneal diameter as well because of lack of significance. Important factors in the H-5 formula include axial length meas- ure, K reading, preoperative anterior chamber depth, and lens thickness. In this formula, the patient's meas- urements are made ratios by the measurements for race and gender. A study of the formula Dr. Hoffer has conducted a small ret- r ospective study in private practice looking at 90 eyes (courtesy of H. John Shammas, MD), breaking them down by race and gender. The study consisted of 51% males and 56% Caucasian patients vs. Latino. With an ME of zero, the MedAE of prediction was 0.36 D±0.34 with a range of –1.47 to +1.11 D. At this time, he said only the H-5 formula has been examined with this study, and he has not yet compared it to other formulas because the series was too small. " I believe that there may be a benefit in using the data provided by the patient's gender and race, and this can easily be incorporated into the IOLMaster [Carl Zeiss Meditec, Jena, Germany], LenStar [Haag- Streit, Köniz, Switzerland], the Aladdin [Topcon Europe, the Netherlands], and any other optical biometer, topographer, or ultra- sound instruments," he said. This would simply require adding specific race and gender information into the formulas and it would be calculated. "This is a very small number of e yes in the study we did, and we didn't compare it to all the other formulas yet; the H-5 formula needs to be evaluated on a much larger series," Dr. Hoffer said. F ollow-up study The study he is currently working on to test his formula is a large interna- tional multiracial and gender study, which will look at the Hoffer H-5 formula in comparison to all other t hird and fourth generation formu- las. Initially Dr. Hoffer believed that he would need around 1,000 eyes in this study, but he has already col- lected a lot of data and received tremendous support from a number of other doctors from around the world that he has reached out to. Already, data for 1,500 eyes has been c ollected, he said. There are 14 col- laborators working with Dr. Hoffer, and a number of others may become involved in the study from countries like Spain, Singapore, India, Italy, Saudi Arabia, the U.K., Iran, Australia, China, Korea, Sweden, and Japan. Where to go from here Dr. Hoffer explained that the reason these factors have not been addressed before is because the Holladay 2 formula has never been published, but he said that the gen- der and race specific measurements in his new formula make sense. The o nly way to use the formula before, he said, was through the Holladay IOL Consultant. By incidentally photographing the exact formula while at Dr. Holladay's course in 1996, Dr. Hoffer was able to recog- nize this potential improvement in its design. " By logic alone, it would make sense that instead of using an average AL, K, ACD, LT for all eyes (Holladay used averages for Western eyes), the use of the average values of race and gender for the individual patient should be more accurate," Dr. Hoffer said. "Many people are saying that g ender may be more of an issue than race," he said. Gender and race will both be taken into account as stud- ies on his formula move forward. EW Contact information Hoffer: KHofferMD@aol.com EW NEWS & OPINION 24 February 2014 The Hoffer continued from page 22 S lide presented by Jack T. Holladay, MD, at his 1996 course showing the structure of the Holladay 2 formula Source: Kenneth J. Hoffer, MD 13-25 News_EW February 2014-DL2-ALT-OIS-ad_Layout 1 1/30/14 10:07 AM Page 24

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