Same-day bilateral cataract surgery gains ground, but obstacles remain

Immediately sequential bilateral cataract surgery, or ISBCS, has been at the center of a lively debate in ophthalmology for many years. Although more widely accepted today and growing as a practice in countries that value its potential to substantially reduce health care and social costs, concerns about safety and suboptimal outcomes have not been entirely dispelled. Compensation is another key issue: Treating the second eye on the same day is not reimbursed or only partially reimbursed in several countries.

Steve A. Arshinoff, MD, FRCSC, of York Finch Eye Associates, Toronto, and Björn Johansson, MD, PhD, of Linköping University Hospital, Sweden, are co-presidents of the International Society of Bilateral Cataract Surgeons (iSBCS). Founded in 2008 to promote education, mutual cooperation and progress in performing bilateral surgery, the society has a growing membership in 23 countries worldwide.

“Members of the society are doctors who perform ISBCS or are interested in the concept, want to learn more and have a backup because this approach is controversial. In some countries, it is not rare to be attacked fiercely by colleagues. However, we regularly present our results at international meetings, hold courses and have seen the interest in this concept grow in the past few years,” Johansson said.

Sweden is one of the countries in Europe where the bilateral approach has significantly increased over the past 10 years. According to the national cataract register, which collects data on 96% of cataract extractions in the country, it was used in 3% to 4% of procedures in 2000 and is now up to 9%.

“In my clinic, it has stabilized at approximately 25% to 30%,” Johansson said.

ISBCS is well established in Finland, where it is performed in 50% of cases, and in the Canary Islands, which has reached the highest rate worldwide at 80%.

According to the 2013 survey of the European Society of Cataract and Refractive Surgeons, approximately 9% of European surgeons offer the simultaneous bilateral option to their patients. Similar rates are reported by surveys among members of the International Society of Refractive Surgery and the American Society of Cataract and Refractive Surgery.

Advantages of ISBCS approach

Advocates of ISBCS emphasize the advantages for the patient in terms of faster visual rehabilitation, less emotional stress and fewer hospital visits.

“With bilateral surgery, we minimize the occurrence of anisometropia, especially in highly myopic or hyperopic patients, and also avoid stereopsis dysfunction,” Andrzej Grzybowski, MD, PhD, an iSBCS member and professor at the University of Warmia and Mazury in Olsztyn, Poland, said.

“Our brains see by summation of the images from two eyes. When you treat only one eye, you affect the patient’s perception beyond Snellen acuity. But by treating both eyes on the same day, patients are really pleased with how much better they see immediately, restoring binocularity, normal stereopsis, color vision and other visual parameters. There is a huge ‘wow factor’ in ISBCS,” Arshinoff, an OSN U.S. Edition Cataract Surgery Section Member, said.

“Most patients prefer to put up only once with the inconveniences and emotional stress of having surgery,” Johansson said. “And when general anesthesia is needed, it is better to be exposed to it once rather than twice.”

The bilateral approach is also more cost-effective, Grzybowski said. It cuts down on the direct costs of preoperative preparation, postoperative care and administrative tasks, as well as the indirect costs of temporary disability, missed work for younger active patients and reliance on the support of others for older patients.

“If we look back in history when LASIK was first introduced, the interval between the two eyes was 6 months, then it was shortened to 3 months and eventually to 1 week. It shows that first we have doubts, but then the procedure proves safe and we shorten the time. I believe that lens surgery will follow a similar progression,” he said.

Concerns about bilateral complications

In a letter to the editor that appeared in American Journal of Ophthalmology in August 2014, Andrew P. Schachat, MD, vice chairman for clinical affairs at Cole Eye Institute, Cleveland Clinic, USA, expressed concerns about same-day surgery. He commented on an article by Li and colleagues who, in consideration of the growing financial burden of cataract and low risk of endophthalmitis, advocated widespread introduction of bilateral surgery.

“I am not sure I want to explain to the unfortunate bilaterally blind patient my risk/benefit and cost/convenience thinking that leads to the collaborative decision to undertake bilateral simultaneous surgery,” Schachat wrote.

“For me, the theoretical risk and anxiety of managing bilateral simultaneous endophthalmitis is worrisome,” he said in an interview with OSN.

According to Oliver Findl, MD, chair and associate professor of ophthalmology at Hanusch Hospital in Vienna, Austria, even more worrisome is the potential risk of having toxic anterior segment syndrome (TASS) in both eyes.

“When a [TASS] outbreak occurs on one day and in the same operating theater, typically several eyes are affected. It can be very severe, and you can end up blind as a consequence of severe glaucoma, corneal decompensation, uveitis or toxicity to the retina. I never had an outbreak yet in my institution, but the chance can never be excluded. Sources are many: It can be the irrigating solution, the surgical instruments, residuals from the cleaning process, the viscoelastic, even the IOL and IOL cartridge,” he said.

In his clinic, same-day bilateral cataract surgery is only performed in patients who require general anesthesia, and a strict, dedicated protocol is applied.

“Before we operate on the second eye, everything is cleaned again, a new eye drape is applied, and everyone changes gowns and gloves. We have to ensure that from one eye to the other eye no product is used from the same lot and even the same company. An electronic system tells us where the tray was washed, and we never use trays that were washed in the same machine or had undergone the same sterilization procedure. Pre-packed instruments must be from either a different lot or a different manufacturer, and the same applies to irrigating solution and viscoelastic. Cefuroxime is administered in one eye and not in the other eye, just in case the formulation may be incorrect,” Findl explained.

“Such a stringent and logistically challenging protocol is fine for one or two patients a week, but if we did it on a regular basis, it would be a logistical nightmare,” he said. “It would cost at least as much time as to change from one patient to another, and it would be neither time saving nor cheaper.”

A low risk

Arshinoff was the lead author of a 2011 article in the Journal of Cataract and Refractive Surgery that found that the incidence of postoperative endophthalmitis after immediate sequential bilateral cataract surgery in a survey of ISBCS members “was extremely low,” he said.

More impressive, “the risk of having a bilateral infection in a bilateral simultaneous procedure, even if one assumes increased risk by a threefold linkage factor, was about one in 100 million,” Arshinoff said. “And postoperative endophthalmitis rates are continuing to decline globally with the acceptance of intracameral antibiotic prophylaxis.”

Grzybowski said that only four cases of bilateral endophthalmitis have been published since 1952, all before the release of the ISBCS safety protocol and none after its release.

“There is no evidence of a higher risk of endophthalmitis in bilateral than separate surgery. We have data of more than 100,000 bilateral procedures worldwide and not a single case of endophthalmitis has occurred,” he said.

According to Johansson, safety concerns are understandable.

“This concept should not be undertaken lightly because you can never be certain about postoperative complications. Although the most discussed complication is endophthalmitis, which has been described in both eyes after bilateral surgery, you must pay attention to complications such as postop corneal edema and cystoid macular edema,” he said.

Power adjustment and visual outcomes

An argument in favor of delayed surgery in the second eye is that it allows adjustment of the IOL power based on the results of the first eye, leading to better accuracy and overall visual outcomes.

Findl said that no matter how good a surgeon is with biometry and IOL power calculation, deviations from target refraction occur, as shown by numerous studies.

“In spite of our best efforts, there are patients whose refractive outcome is not as good as we would like it to be. So when the patient comes for second eye surgery, we can adapt the lens power accordingly to try to get closer to our goal,” Findl said.

“This is something I don’t want to lose. I don’t want to lose the possibility to make the second eye better,” he said.

According to Grzybowski, accurate patient selection overcomes potentially suboptimal outcomes

“I would never recommend ISBCS to patients with atypical eyes, shorter or longer, when there is suspicion that biometry might not be accurate and we can expect refractive surprises. In these cases, better do separate surgery. But the risk of refractive error is low and usually within ±1 D at the most in 90% of the cases,” he said.

Reimbursement issues

Reimbursement policies for ISBCS vary substantially between and within countries and may have a significant impact on the acceptance of the procedure.

“It’s hard to believe, but it’s a fact: There is no reimbursement for the second eye in some countries,” Johansson said, including Israel, Japan and Poland.

In the U.S., the second eye is paid at 50% if performed on the same day, and in Canada, between 50% and 80%, depending on the province.

“It is very common in many jurisdictions for surgeons to schedule the second eye on the first day that the payer will allow full payment,” Arshinoff said. This time frame can vary from 1 day to 1 or 2 months.

“This is a reason why the same-day procedure is more often performed on a private basis and why it is more common as refractive lens exchange. Significantly, also in the ASCRS survey, numbers were much higher for RLE than cataract. Fear of complications and suboptimal outcomes seems to become less of a concern when money issues are not involved,” Grzybowski said.

According to Findl, however, financial issues may not weigh a great deal on the choice.

“Reimbursement may be an issue in some health systems, but in my country, there is only a small deduction for the second eye. This is not one of my arguments,” he said. – by Michela Cimberle and Bob Kronemyer

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• Seguridad, efectividad y coste-efectividad de la cirugía de cataratas bilateral y simultánea frente a la cirugía bilateral de cataratas en dos tiempos. aunets.isciii.es/ficherosproductos/sinproyecto/534_SESCS-2006_05.pdf. Accessed Jan. 7, 2015.
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• For more information:
• Steve A. Arshinoff, MD, FRCSC, can be reached at York Finch Eye Associates, 2115 Finch Ave. W, No. 316, Toronto, ON, Canada M3N 2V6; email: ifix2is@gmail.com.
• Oliver Findl, MD, can be reached at Department of Ophthalmology, Hanusch Hospital, Vienna, Austria; email: oliver@findl.at.
• Andrzej Grzybowski, MD, PhD, can be reached at Department of Ophthalmology, ul. Szwajcarska 3, 61-285 Poznan, Poland; email: ae.grzybowski@gmail.com.
• Björn Johansson, MD, PhD, can be reached at Department of Ophthalmology, Linköping University Hospital, SE- 581 85 Linköping, Sweden; email: bjorn.johansson@regionostergotland.se.
• Andrew P. Schachat, MD, can be reached at Cole Eye Institute, i-30, 9500 Euclid Ave., Cleveland, OH 44195, USA; email: schacha@ccf.org.

Disclosures: Arshinoff, Findl and Grzybowski report no relevant financial disclosures. Johansson reports he is a paid consultant for Alcon, Abbott Medical Optics, Bausch + Lomb and Théa. Schachat reports he is a paid consultant to AnGes MG, Bausch + Lomb and Allergan.

Is immediately sequential bilateral cataract surgery a feasible approach in pediatric patients?

Fast re-education of vision is crucial in children

I routinely do immediately sequential surgery in my pediatric patients. I use special transparent shields they cannot take off to protect the eyes from rubbing and trauma and to prevent postoperative infection. I also use the bag-in-the-lens technique and IOL, which prevent secondary cataract and make rehabilitation quick and uneventful. Fast re-education of vision is crucial in children after surgery.

The argument in favor of operating the eyes separately is that you can better adjust the IOL power of the second eye after you have seen the outcomes of the first eye. But I do not think this is necessarily correct. Biometry is done in both eyes, and when there are differences in the development of one eye as compared with the other, the IOL power is calculated accordingly to compensate for possible aniseikonia. This condition is, however, rare in bilateral cataract in children and more related to unilateral developmental cataract. A different corneal curvature of more than 3 D and a difference in axial length of more than 1 mm is quite rare in cases of bilateral cataract.

I no longer implant an IOL that is more than 30 D because lenses that are too thick produce a high amount of aberrations, mainly spherical aberration. I trust the eye will grow and compensate the residual refractive error. In the meantime, the child is corrected with contact lenses or spectacles. After a few years, we can usually throw them away and parents are happy. Even if the child loses his or her contact lenses frequently, the eye is pseudophakic, not fully corrected but corrected enough for the child to keep useful vision. A deficiency of +3 D to +5 D is not a big deal for children. In these cases, spectacles are prescribed as soon as possible.

I am aware that this approach is no more than a well-motivated opinion. There is no multicenter study comparing the results of separate vs. simultaneous surgery. Consequently, there are multiple approaches, none of which are validated. We can only evaluate our results in the long term and case by case.

Marie-José Tassignon, MD, PhD, is an OSN Europe Edition Associate Editor. Disclosure: Tassignon reports she has a proprietary interest in the BIL (Morcher) and is a consultant to Morcher, Théa and Ellex Medical Lasers.

An interval between eyes can be advantageous with fewer risks

I do not say I never operate the two eyes simultaneously in children. There is a place for this approach in specific cases, such as when a patient is high risk for general anesthesia and in cases of severe malformation with systemic problems. In all other cases, I prefer to operate the two eyes on separate days. I wait 1 or 2 weeks at the most in between eyes, depending on age and visual development. In an infant older than 2 months, you have to be quick, and 1 week is enough. But if a child is amblyopic, a longer interval may allow the lazy eye to gain more visual acuity. I always operate on the nondominant eye first and take advantage of the interval before the other eye is operated to provide the extra stimulation that will rebalance vision. The interval between the two eyes also allows us to adjust the IOL power. This is particularly important in children because accurate calculation is more difficult than in adult eyes.

Of course, a major argument against same-day bilateral surgery is the risk of infection such as endophthalmitis. Bilateral infection carries the risk of bilateral visual impairment or even blindness. No matter how careful we are with changing the instruments and everything else in between procedures, bacteria can be anywhere in the operating room.

Another important point, which will be stated in the soon-to-be-released guidelines of an international group of pediatric surgeons, is that two shorter-acting doses of general anesthesia are better than a longer one and carry less risk of short- and long-term side effects.

Dominique Brémond-Gignac, MD, PhD, is an OSN Europe Edition Board Member. Disclosure: Brémond-Gignac reports no relevant financial disclosures.