I began to practice routine bilateral cataract surgery in 1996, encouraged by a 35-year-old race car driver who advised me that, if I would not do it for her, she would simply go elsewhere. Having been to other surgeons, she was aware of the risks purported to attend the surgery but was unwilling to undergo two unilateral procedures for her bilateral cataracts. Her attitude caused me to rethink the paradigms I had been taught as a resident. Was there really a good reason not to perform same-day bilateral modern phacoemulsification with in-the-bag posterior chamber IOL implantation, or were we just following the supposed wisdom of our forbearers who did not have access to technology and techniques remotely as safe and effective as those currently available?

At present, immediate sequential bilateral cataract surgery (ISBCS; the preferred term) is rapidly increasing in popularity worldwide. The government of Spain has recently recognized ISBCS to be as safe and effective as two unilateral procedures, or delayed sequential bilateral cataract surgery (DSBCS).¹ Approximately 10% of European cataract surgeons routinely perform ISBCS, with the highest rates in Finland and Sweden; in Ontario, Canada, more than 2.5% of cataract procedures are performed as ISBCS, and in the United States, 5% of American Society of Cataract and Refractive Surgery (ASCRS) members routinely perform refractive lens procedures as ISBCS.² Today, the International Society of Bilateral Cataract Surgeons (iSBCS, www.isbcs.org) has members in Canada, the United Kingdom, Australia, the United States, Spain, Sweden, Finland, Belgium, India, Korea, Portugal, Syria, Malaysia, Norway, and Switzerland, among other countries.

JUSTIFICATION

Many reasons have been cited for performing ISBCS.^3-6 After ISBCS, patients experience almost immediate visual rehabilitation, whereas DSBCS patients experience loss of true binocularity until surprisingly long after recovery from second-eye surgery.³ Additionally, fewer medical visits are required with ISBCS (40% fewer visits, according to most studies), yielding happier patients and happier family members who transport them.

ISBCS also yields efficiencies in the operating room (OR) and less hurried cataract surgery days. More ISBCS cases can be performed daily compared with DSBCS, and calmer care can be given to patients in a less harried ISBCS day.⁴ Additionally, ISBCS reduces patient fear and is preferred for patients needing general anesthesia or other special accommodations for surgery.

Surgeons who frequently practice ISBCS are usually willing to operate on an amblyopic or previously injured eye, often yielding surprisingly good results. In most cases, these eyes would be left functionally blind or cosmetically poor by surgeons who do not perform ISBCS and are unwilling to take a patient to the OR for the sake of an eye with a marginal prognosis. ISBCS also saves the medical system huge amounts of money (billions of US dollars per potential case of bilateral endophthalmitis—a mathematical risk that would also happen with DSBCS, only at different times), which, although not a reason to judge any medical procedure, is important in the current worldwide financial crunch in medicine.^5,6

OBJECTIONS TO ISBCS

Despite the benefits laid out above, a number of (loud) objections have been raised against ISBCS, giving rise to broad controversy. These objections deserve to be reviewed:

No. 1: The preferred practice documents of many countries do not recognize ISBCS as a standard form of practice. Preferred practice documents recount the current state of practice; however, they are written about 1 year before they are published and therefore cannot encompass a new procedure as accepted standard practice. For example, IOLs and, more recently, intravitreal antiangiogenic injections for retinal disorders were not accepted just before they became standards of practice.⁴

No. 2: Postoperative bilateral retinal detachment has been stated as an unacceptable risk of ISBCS. Retinal detachment generally occurs months or years after cataract surgery and most commonly occurs in an identifiable population of white males with preoperative refractions of -4.00 to -8.00 D of myopia.⁴ The timing of postoperative detachments makes it irrelevant whether the patient’s two operations occur 3 minutes or 3 months apart, and the fact that the population most at risk is identifiable enables pre- and postoperative retinal assessments for prophylactic treatment of the high-risk group, if needed.⁴

No. 3: Bilateral cystoid macular edema (CME), diabetic macular edema, and corneal decompensation (in eyes with Fuchs dystrophy) have been cited as other significant risks. The majority of surgeons who perform ISBCS agree that each of these entities is a specific relative contraindication for ISBCS.^7,8 However, of these, only CME can be unpredictable, and most ISBCS surgeons give perioperative NSAIDs to minimize that risk. In reality, having performed ISBCS on more than 7,000 eyes, I have found that bilateral significant CME sufficient to impair the patient’s normal activity has yet to occur in my practice.

No. 4: IOL power errors that may occur with the first surgery cannot be detected before the second. I have only had to exchange an IOL half a dozen times (less than one case in 1,000), almost all of which occurred before the advent of partial coherence interferometry and the introduction of the Haigis equations and the ASCRS calculator for use after refractive surgery. Furthermore, these IOL exchanges were required in extreme hyperopes or high myopes in whom the fovea was on the slope of a staphyloma. In almost all of these cases, data from one eye would not have helped for the other.⁴ Simply put, adjustments to correct IOL power errors in the first eye for the second-eye surgery are not a significant problem in bilateral cataract surgery.⁹

No. 5: Bilateral toxic anterior segment syndrome (TASS) has been cited as a possible risk. TASS usually occurs when something in the surgical protocol has changed, such as the source of balanced saline solution or the type of gloves used by the OR staff. However, TASS has not been reported with ISBCS to date. In our recent study of almost 100,000 ISBCS cases, there were no reports of TASS.10 Article 7E of the iSBCS General Principles for Excellence in ISBCS 2009 (See Principles for Excellence in ISBCS) specifically states that “nothing should be changed with respect to suppliers or devices used in surgery without a thorough review by the entire surgical team to assure the safety of proposed changes.”

No. 6: The largest issue with respect to ISBCS has been the potential of simultaneous bilateral endophthalmitis(SBE). I speak about ISBCS at ophthalmic conferences all over the world; at nearly every meeting, someone opposed to ISBCS has gotten up and stated that he or she would never perform ISBCS because, if even one patient suffered SBE, the catastrophe would be unbearable for both the patient and the doctor. I recall speaking at the New England Ophthalmological Society as the guest of honor in December 2001. To my great surprise, during my lecture on ISBCS, in the front row was seated a team of Boston litigation lawyers who had been invited to attend and comment on my presentation. The audience expected the lawyers to vilify me and ISBCS, but the comments from a representative of the legal team were encouraging. In short, the lawyers recognized that, as with any surgical procedure, ISBCS carries significant risk of morbidity not limited to vision loss. They acknowledged that, in the setting of properly documented informed consent, including the risks of the planned surgery, ISBCS was not out of line with other new procedures being performed in the Boston area.

AVAILABLE EVIDENCE

Following the lawyers’ rationale, ISBCS should be judged on the available evidence and not fear of complications. In fact, ISBCS surgeons are among the most accomplished cataract surgeons with low complication rates. We commonly adopt extra precautions, such as those suggested in the General Principles for Excellence in ISBCS 2009, and we frequently perform our most difficult cases (which may be expected to have a higher infection rate) as DSBCS.

I participated in the most complete study of infection after ISBCS.10 In 95,606 eyes undergoing ISBCS, the infection rate was 1:5,759 for all cases, 1:1,987 for cases not receiving intracameral antibiotic prophylaxis (IC), and 1:14,352 for cases receiving IC with cefuroxime, vancomycin, or moxifloxacin. These infection rates are dramatically lower that the infection rate reported in the IC cefuroxime arm of the European Society of Cataract and Refractive Surgeons (ESCRS) study of endophthalmitis (1:1,621) and lower than the weighted average of all the IC cephalosporin studies reported from Europe in the past decade, which includes 535,948 cases with an IC infection rate of 1:1,977.⁹

These numbers present an achievable goal for all cataract surgeons. All of the infections in our study¹⁰ were unilateral, and no cases of SBE occurred. In the literature, four cases of SBE have been reported between 1978 and 2008. In every case, there was a significant lapse in sterile protocol, and the iSBCS general principles were not followed.¹¹ Members of iSBCS strongly recommend that surgeons new to ISBCS follow these recommendations.

RISK FOR SBE

Using the following formula, SBE Risk = (unilateral surgery risk)² x linkage factor, where the unilateral surgery risk is equivalent to the infection rate in our study (1:14,352), I calculated the approximate risk for SBE when the iSBCS general principles are followed and IC antibiotics are used. The linkage factor represents the extra risk for the second eye in a bilateral case when the first eye was infected. In reviewing the literature and in the experience of iSBCS members, I do not believe the linkage factor would exceed 3. Therefore, the risk for SBE in ISBCS can be assigned a best estimate of approximately 1:70 million.

Choosing an intracameral antibiotic is a challenge, as cefuroxime, vancomycin, and moxifloxacin have all been shown to be effective, but none is significantly superior to another.¹⁰ As we found in our study, there are a number of reasons to prefer moxifloxacin. Moxifloxacin and vancomycin have broader spectra of activity against common endophthalmitis pathogens and less reported resistance than cefuroxime. Unlike the others, moxifloxacin demonstrates dose-dependent rather than timedependent kinetics in bacterial killing, and antinuclear rather than anticell-wall efficacy. It has a low risk of allergy (especially compared with the cephalosporins) and is the simplest to prepare, making dilution errors unlikely. Importantly, in the unfortunate but ultimately inevitable periodic event of failure, moxifloxacin is most likely to yield a resistant strain of Staphylococcus, which will probably be sensitive to the usual antiendophthalmitis drugs of choice, vancomycin and ceftazidime, which act by mechanisms different from those of moxifloxacin. It is microbiologically more logical to use an agent for prophylaxis that is unrelated chemically and by mechanism of action to the current endophthalmitis drugs of choice, vancomycin and ceftazidime, reserving them for rare failures, than to use our agents of last resort, vancomycin or cefuroxime (chemically and microbiologically similar to ceftazidime) as primary prophylactic agents. Finally, even dilute moxifloxacin has a faint yellow color, making administration of the wrong syringe from the nurse’s table unlikely.²

CONCLUSION

There is no evidence that ISBCS is unsafe. The history of the world has shown that life tends toward ever-increasing complexity, as long as the summation of simpler units merging into a more complex unity shows ultimate benefit.¹² Our history in ophthalmology of incorporation of IOL implantation into cataract surgical procedures is a typical example of this.

ISBCS has not been shown to have any demonstrable downside. It does, however, provide many benefits for the patient, for the patient’s caregivers, and for society, as it saves huge amounts of money that can be spent for more cataract procedures or other health needs. The only incontrovertible downside is that, in many jurisdictions, surgeons are paid less for the second eye than for the first, essentially penalizing them for performing ISBCS. No matter how you look at this, it is an incredibly foolish policy. We have a safe procedure, with many benefits for the patient, and we discourage it by penalizing the surgeon who performs it. It would simply be a lot smarter to reward surgeons for ISBCS, thus sharing a small amount of the savings society reaps with the individual who is responsible for those savings. It is not surprising that penalized surgeons are reluctant to perform ISBCS. Therein lies the real root of the controversy and argument about ISBCS.

Steve A. Arshinoff, MD, FRCSC, practices with York Finch Eye Associates, Toronto, Ontario, Canada, and is affiliated with Humber River Regional Hospital, Toronto, Ontario, Canada; University of Toronto, Toronto, Ontario, Canada; and McMaster University, Hamilton, Ontario, Canada. Dr. Arshinoff states that he is a paid consultant to Alcon Laboratories, Inc., and Carl Zeiss Meditec. He may be reached at tel: +1 416 745 6969; fax: +1 416 745 6724; e-mail: ifix2is@sympatico.ca.

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