Poster ID P7 Arshinoff Steve A Simultaneous Bilateral

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 Worldwide status of simultaneous bilateral cataract surgery (SBCS) in 2009 Steve A. Arshinoff MD FRCSC * Eye Associates, Humber River Regional Hospital, University of Toronto, Ontario, Canada. Mc. Master University, Hamilton, Ontario, Canada. ASCRS – 2009 Sa Francisco, CA, USA Introduction: Personal Background with SBCS (SAA): Simultaneous bilateral cataract surgery (SBCS) offers potentially excellent advantages of rapid recovery, convenience, and economic savings for the patient and the health care system. Global acceptance of SBCS varies dramatically , but is increasing. This poster examines the current global status of SBCS. v Financial Disclosure : The author acknowledge no financial interest in anything discussed herein. v v v I am probably the world’s foremost advocate of SBCS, having operated on in excess of 3, 000 completely elective SBCS patients since 1996, and published the results of the first 1020 consecutive patients. 1 In the >6, 000 eyes completed, not a single eye suffered a deleterious effect because of the simultaneous bilaterality of their surgery. I have never had a single patient express dissatisfaction with having chosen to undergo SBCS. Many of my patients, who had chosen to undergo unilateral cataract surgery (UCS) x 2, were sorry they did not choose SBCS, when they sat in the office waiting room on POD 1 with SBCS patients. Arshinoff Steve A, Strube YNJ, Yagev R. Simultaneous Bilateral Cataract Surgery. J. Cataract Refract Surg. July 2003. 29: 7; 1281 -1291. 1 1

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 2 Purpose & Method Purpose: Method: To review available literature and surgeon experiences with SBCS, from around the world, and assemble the information in a manner that might clarify the, prevalence, acceptance & issues surrounding SBCS. A literature review was conducted online (Pub. Med), along with preferred practice documents from different countries. Reviews of our own experience & that of members of the International Society of Bilateral Cataract Surgeons (i. SBCS) raised by the literature review were conducted. SBCS, or ISCS (Immediately Sequential Cataract Surgery), is not to be embarked upon lightly. It is the obsessive, meticulous, sequential performance of 2 independent, separate & sterile cataract procedures on the same patient, in order to gain the benefits of immediate bilateral visual recovery, usually including normal stereopsis. SBCS requires motivated staff, eager to do better, and access to current technology, as well as ongoing reassessment of performance standards.

Poster ID # P-7 n Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 Background: Problems collecting SBCS data Collegial Hostility, Oh, it’s a custom from the old country. Why didn’t you say so? similar to what occurred with the Oh, it’s a custom from the old country? ! Why didn’t you say so! advent of the first IOLs & phacoemulsification, prevents SBCS surgeons from coming forward to present data. n Establishment There has been a general failure in Ophthalmology to consider SBCS, or even to permit open discussion at most academic meetings. n 3 However, different jurisdictions offer varying opportunities to discover what is being done by surgeons. SBCS surgeon

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 Who Performs SBCS? SBCS in Ontario (ON), Canada The Government of Ontario collects data on all aspects of government-controlled health care, including which patients were billed for cataract surgery in both eyes on the same day. Ontario SBCS % Cataracts in Ontario 1. 80% 1. 60% ON SBCS YEAR AUTHOR All ON AUTHOR / ON % ON Cats % of Cats (Apr 1 - Mar 31) 1. 40% # EYES S B C S EYES UNDERGOING CATARACT (CAT) SURGERY in Ontario (ON) 1. 20% 1. 00% 0. 80% 0. 60% 2003 -4 498 1016 49. 02% 99825 1. 02% 0. 40% 2004 -5 488 1346 36. 26% 108480 1. 24% 0. 20% 2005 -6 682 1862 36. 63% 126384 1. 47% 0. 00% 2006 -7 556 1642 33. 86% 139387 1. 18% 2007 -8 538 2196 24. 50% 139101 1. 58% 2003 -4 2004 -5 2005 -6 2006 -7 2007 -8 Year Conclusion: SBCS is increasing in frequency Ontario. - Absolute numbers have increased >100% over 5 years (1016 2196) - Percent of total cataract cases has increased 56% over 5 years (1. 02% 1. 58%) - Preliminary data suggests that the other Canadian provinces are similar. 4

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 5 US & Europe: Performing & Discussing SBCS ESCRS Members Performing SBCS 6. 4% 6. 6% (ASCRS = ± 0) 7. 2% 7. 8% Probably because of financial penalties for performing SBCS, very few American surgeons (ASCRS members) routinely perform SBCS. Despite the percent of ESCRS members performing SBCS gradually increasing, academic societies are often unwilling to permit courses on SBCS at meetings. We (Charles Claoue, Steve Arshinoff, John Bolger, Sulevi Kaipiainen, Richard Packard & Johann Kruger) YEAR Source: ESCRS annual surveys conducted by David Leaming, MD, 2004 -2007 (www. leamingsurveys. com) have submitted proposals for SBCS courses at the last 5 ASCRS & ESCRS meetings, with the following results: SBCS Courses 2005 2006 2007 2008 2009 ASCRS rejected accepted rejected ESCRS rejected accepted

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 Why not do SBCS: The 3 big fears with SBCS 1. Post operative retinal detachment (R/D) • 2. 3. In almost all cases, R/D occurs sufficiently late that the second eye would have already had surgery, whether SBCS or UCS (unilateral). IOL power errors in 1 st eye, correctable for 2 nd eye ? • Errors are very rare using partial coherence interferometry, new Haigis L equation, and ASCRS post refractive surgery calculator. • *Jabbour : No benefit to inter-procedural recalculation of IOL power. Bilateral post operative endophthalmitis (POE) & TASS (Toxic Anterior Segment Syndrome). • Only remaining significant concerns. *Jabbour J, Irwig L, Macaskill P, et al. Intraocular lens power in bilateral cataract surgery: Whether adjusting for error of predicted refraction in first eye improves prediction in the second eye. JCRS 2006; 32: 2091 -2097. 6

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 Fears of SBCS: 3. Bilateral Endophthalmitis There have been 4 reported cases to date: 1. * Ben. Ezra 1978 Malawi bilateral blindness Patient had septicemia & dysentery Both eyes operated with same instruments – ICCE. 2. ** Ozdek 2005 Turkey bilateral visual recovery 70 yo healthy male, same irrigating fluids, new drape, flashed same instruments, no antibiotic prophylaxis. BCVA recovered to 20/50, 20/40, after 1 month. 3. *** Kashkouli 2007 Iran bilateral blindness 67 yo male SBCS same instruments bilateral Pseudomonas 1 eye phaco/foldable IOL, 2 nd = unplanned ECCE & 6 mm PMMA IOL. Same doctor, preceding day, 1 SBCS patient blinding infection with the same Pseudomonas bacteria – 1 eye. (PDF protected from copying) 4. ****Puvanachandra 2008 UK bilateral visual recovery to 6/9 ou. 81 yo female. 3 piece acrylic IOLs with intracameral cefuroxime, postop Tobradex ® QID Different equipment used from the same autoclave sterilization cycle without indicators. 4 days post op bilateral Staph. epidermidis endophthalmitis – same strain in both eyes. There have been no reported cases of bilateral endophthalmitis after SBCS when complete sterile separation of the 2 procedures has been followed, and no reported cases of TASS post SBCS. * Benezra D, Chirambo MC. Bilateral versus unilateral cataract extraction: advantages and complications. Br J Ophthalmol 1978; 62: 770– 3. ** Ozdek SLC, Onaran Z, Gurelik G, et al. Bilateral Endophthalmitis after simultaneous bilateral cataract surgery. JCRS 2005; 31: 1261 -62. *** Kashkouli MB, Salimi S, Aghaee H, et al. Bilateral Pseudomonas aeruginosa endophthalmitis following bilateral simultaneous cataract surgery. Indian J Ophth. 2007; 55: 374 -5. ****Puvanachandra N, Humphry RC. Bilateral endophthalmitis after bilateral sequential phacoemulsification. JCRS 2008; 34: 1036 -7. 7

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 8 Post SBCS Endophthalmitis: ASCRS & ESCRS SBCS Course Speakers’ Cases Post op Endophthalmitis Eyes Unilateral Bilateral Steve Arshinoff Toronto, Canada >6, 000 0 0 Charles Claoué London, England ~1, 000 0 0 Richard Packard London, England 750 0 0 John Bolger London, England >6, 600 3 0 Sulevi Kaipiainen Joensuu, Finland >12, 000 2 0 Johann Kruger Cape Town, South Africa ~7, 000+ 5 0 ~33, 000+ 10 0 Overall incidence = 10/33, 000 = 1/3, 300 = 0. 03 % unilateral, 0. 00 % bilateral * (Cefuroxime arm - ESCRS study = 1/1, 400 = 0. 07 %) The incidence of post operative endophthalmitis among these experienced SBCS surgeons is half that of the intracameral cefuroxime treated arm of the ESCRS study, and none were bilateral infections. * ESCRS Endophthalmitis Study Group. Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. JCRS 2007; 33: 978 -988.

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 Enhancements instituted by author, SAA, to reduce risks of SBCS 1. 9 Intracameral antibiotics (Vigamox (moxifloxacin) 100 µg/0. 1 cc BSS) - Post op antibiotics 6 x/day x 3 d, then QID x 7 days (Vigamox). No patches. 2. Separation of R & L OR tables. -Strict avoidance of cross contamination. -Always do L eye first (far from R table). - Nothing goes from R L or L R. 3. Phaco machine screen faces surgeon Second table remains untouched by nurse, until 1 st eye is finished and she has changed her gloves. Pt data: R&L IOLs & cylinders Second table is far from surgical field. List criteria (IOL type, power & astig. ) for R & L eyes on board in OR, visible to all. 4. “Everyone who touches the IOL must make sure it is correct. ” - Staff taught to review IOL calculations, & to recite them, as IOL is passed. 5. Different OVDs for R & L eye, & everything as different as possible. 6. Avoid changing scrub nurse in the middle of one eye’s surgery.

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 10 The cost of UCS compared to SBCS n At the Annual ESCRS meeting, 2008, Berlin: • Tiina Leivo, Helsinki University Eye Hospital, Finland • Risk of Bilateral Simultaneous Endophthalmitis (BSE) ≤ 1/1, 000 (& it may be much lower ? 1: 10, 000 ? ): • Savings of SBCS is estimated at € 1, 600 per patient. - Including social and administrative costs (not incl. doctors’ fees), n The additional cost to prevent 1 case of BSE, by avoiding SBCS is: € 739 M / case $ 1 B USD (Remember, mathematically, this same individual would still experience unilateral endophthalmitis x 2 separately) n Conclusion: There are better ways to spend $1 B USD, in health care, than by performing elective UCS, instead of SBCS.

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 Worldwide evolution and acceptance of n SBCS is: “The obsessive, meticulous, sequential performance of 2 independent, separate & sterile cataract procedures on the same patient, in order to gain the benefits of immediate bilateral visual enhancement. ” n SBCS restores binocular vision, as nature gave it to us, not monocular acuity. We should begin to think of ourselves as capable of restoring “normal sight. ” n Progressive interest. SBCS is common in: Finland, Great Britain, Spain, Turkey, Sweden, Poland, Canada, Austria, China, Iran, South Africa. n Many jurisdictions financially penalize doctors for SBCS leading to reluctance to perform SBCS*. n USA, Israel, Japan. Finland: many hospitals perform more than 50% of all cataract surgeries as SBCS (Sulevi Kaipiainen MD - personal communication). *Arshinoff SA, Chen SH. Simultaneous bilateral cataract surgery: Financial differences among nations and jurisdictions. J Cataract Refract Surg 2006; 32: 1355– 1360. 11

Poster ID # P-7 Arshinoff Steve A. Simultaneous Bilateral Cataract Surgery: 2009 12 International Society of Bilateral Cataract Surgeons n Founding members SURGEON www. i. SBCS. org LOCATION #SBCS EYES PERFORMED Steve Arshinoff Toronto, ON, Canada > 6, 000 Charles Claoué London, England, UK ~ 1, 000 Richard Packard London, England, UK John Bolger London, England, UK > 6, 600 Sulevi Kaipiainen Joensu, Finland >12, 000 Johann Kruger Cape Town, South Africa David Pérez Silguero + group Gran Canaria, Spain 750 + 28, 000 TOTAL SBCS EYES n 7, 000 + 61, 000 i. SBCS was founded because we believe that as cataract surgery moves to refractive lens exchange in 55 year olds, for multifocal or accomodating IOLs, we will all do predominantly SBCS is becoming rapidly more common around the world, and an open, honest, forum for information exchange is needed to make the transition informed and safe. Please join us, and take part in this exciting transition. Steve Arshinoff MD FRCSC ifix 2 is@sympatico. ca ifix 2 is@i. SBCS. org