Simultaneous bilateral cataract surgery courts controversy in US but has wider use abroad

Johann A. Krüger, MD, who works in South Africa, offers SBCS to all his patients. Image: Krüger JA

As the trend for simultaneous bilateral cataract surgery grows worldwide, the technique could be the way of the future for cataract surgery, saving millions of dollars in health care funds and restoring patients’ full vision faster.

However, simultaneous bilateral cataract surgery (SBCS) is not often practiced in the United States, with cataract surgery performed as two separate, unilateral procedures being the more popular method. The risk of bilateral infection and other complications dissuades many U.S. physicians from performing SBCS.

“There’s a small chance of a big problem,” Richard J. Mackool, MD, who practices in New York, said. “We prefer not to take that small chance.”

SBCS is widely practiced in other countries, including Finland, Sweden, England, Spain and South Africa. The topic can be controversial and has many proponents and opponents across the globe.

Steven A. Arshinoff, MD, FRCSC, Charles Claoué, MD, FRCS, and John Bolger, FRCS, recently started the International Society of Bilateral Cataract Surgeons to facilitate worldwide discussion about the subject. Dr. Arshinoff, an expert in SBCS who has performed the procedure on more than 3,000 patients (6,000 eyes), said he started the society after querying fellow surgeons in Canada about performing the procedure.

To his surprise, more Canadian physicians than he anticipated said they performed the procedure. Many physicians are reluctant to discuss their experiences with SBCS because of the controversy surrounding it, Dr. Arshinoff said.

Steven A. Arshinoff

He predicted that the procedure may eventually become more popular in the United States.

“Whenever anything is better for the patient, in the end, it wins,” he said. “The level of hostility about procedural change is usually proportional to the amount of change from current practice and how threatening tangential issues are and how scary the step to the proposed change appears to be. I think it’s a compliment to bilateral cataract surgery that it has gotten so much hostile response. Intraocular lenses and phacoemulsification received similar welcomes when they were new.”

Resistance to SBCS in the U.S.

One major reason why SBCS is not widely used in the U.S., according to Dr. Arshinoff, is the fact that Medicare pays for only half of the usual fee for the second eye when performed as SBCS, as opposed to paying fully for both eyes when surgery is performed in two procedures.

Richard J. Mackool

The procedure should be used for appropriate reasons, such as offering patients the benefits of same-day surgery, according to Björn Johansson, MD, PhD.

Dr. Johansson, who practices in Sweden and has performed about 1,200 SBCS cases, said the procedure should never be performed as a means of cutting corners or increasing patient turnover.

“To perform an intraocular operation means that there is a risk for not only infection, but other vision-threatening complications as well,” he said. “To use SBCS means that we buy shorter rehabilitation time and increased quality of life, with the risk that an uncommon complication will hit both operated eyes.”

Risk of infection

Opponents of frequent use of SBCS cite the risk of bilateral infection as one of the main reasons for not performing it.

According to Dr. Arshinoff, there have been four reported cases of bilateral endophthalmitis after SBCS. The first was reported in 1978 by BenEzra in Malawi. The patient was septic and suffering from dysentery and received intracapsular cataract surgery. The bilateral infection resulted in blindness. The surgery was performed with the same instruments used for both eyes.

The next reported infection was by Ozdeck in 2005 in Turkey. In this case, the same irrigating solution was used in both eyes, and no antibiotic was given prophylactically. The patient did not go blind, but had a bilateral visual recovery of 20/50 and 20/40 at 1 month.

In 2007, a case of bilateral blindness was reported by Kashkouli in Iran. The same instruments were used for both eyes. The first eye underwent routine phaco with a foldable IOL, and the second eye had an unplanned extracapsular cataract extraction with a 6-mm PMMA IOL. The preceding day, the same surgeon had a patient suffer blinding endophthalmitis in one eye with the same Pseudomonas bacterium that infected the two eyes of the bilaterally infected patient.

The most recent case, in 2008, was reported in the United Kingdom by Puvanachandra. The patient had excellent visual recovery after the infection. Complete details about this patient are not yet clear enough to ascertain whether complete sterile and separate conditions were followed, Dr. Arshinoff said.

There have been no reported cases of toxic anterior segment syndrome with SBCS.

Dr. Arshinoff collected infection data on more than 55,000 SBCS eyes by 10 physicians, including his own cases. There were 12 cases of unilateral endophthalmitis for an incidence of one in 4,580 cases (0.022%), he said, with no incidence of bilateral endophthalmitis.

This unilateral infection rate among experienced SBCS surgeons was one-third the 0.07% incidence in the intracameral cefuroxime-treated arm of the European Society of Cataract and Refractive Surgeons endophthalmitis study, Dr. Arshinoff noted.

Reducing infection

Although there is a risk of infection with SBCS, physicians can successfully manage that risk, Dr. Arshinoff said. He said there are three essential qualities that a surgeon must have to perform SBCS: a low surgical complication rate of 1% or less, reliable staff and access to current technology.

“You can’t be doing bilateral surgery if you have a 5% complication rate in unilateral eyes. Your office would be packed full of people with complications,” Dr. Arshinoff said. “You have to be able to do surgery with very few complications. If you look at ophthalmology for the last 20 years, it’s been a slow process of us looking at one problem after the next and finding ways to prevent them.”

The key to safe SBCS is to treat the procedure as two separate surgeries performed 5 minutes apart, according to Dr. Bolger, who practices in England. He has performed SBCS on more than 6,500 eyes in the last 13 years, with two cases of endophthalmitis, both of which were unilateral infections.

“I treat each eye as if it is two different patients. Everything is completely changed,” he said. “All the equipment, all the gowns, gloves, infusions, everything. It’s as though it’s two different patients – you have Joe Smith 1 and Joe Smith 2. Nothing from the first eye is used on the second eye.”

Patients are also given two separate postoperative topical drops to avoid cross-contamination. Dr. Bolger said his patients understand they should not switch bottles between eyes.

Proponents of SBCS said that endophthalmitis can occur even in unilateral cases. But with unilateral surgeries, patients must travel to the office more frequently for operations and postoperative visits than for SBCS, so this could potentially increase their risk factors in other ways. Dr. Claoué has performed more than 1,000 SBCS cases in the last 10 years in England and said balancing risk factors is important.

“For example, if 500,000 people have bilateral sequential cataract surgery, there will be about 1,000 unilateral cases of endophthalmitis,” Dr. Claoué said. “If they had simultaneous bilateral cataract surgery, you would see 998 cases of unilateral endophthalmitis and one case of simultaneous bilateral endophthalmitis. However, because of the extra miles traveled, about three of the first group would die in road traffic accidents. So which is ‘better?’”

Other risks

While the risk of infection appears to be the most cited complication in the literature, other risks should also be considered, according to Dr. Johansson. He said cystoid macular edema and corneal decompensation should be considered before performing SBCS.

“Preoperative selection of suitable cases and, more important, detection of cases unsuitable for SBCS needs to be carried out with great care and excellent quality,” he said. “Although we do have a structured checklist which can be used by any ophthalmologist when deciding about SBCS, in clinical practice our experienced surgeons are responsible for these decisions to ensure maximum safety.”

The risk of refractive errors from performing surgery on both eyes on the same day, instead of providing patients a chance to adjust to the first IOL implantation, is another issue with the procedure, Dr. Mackool said.

“In my experience, the greatest safety reason is you don’t get to see what their refractive result is in the first eye and how the patient likes that refractive result,” he said.

Dr. Mackool said he has encountered many patients who have requested a different lens in the second eye after experiencing vision in the first. Modifications in the second eye with information gleaned from postop visual adaptation is not possible with simultaneous surgery.

Other physicians say that clinical experience and research have shown that adaptation and deviation from refractive targets is not a problem with SBCS. Furthermore, recent work by Jabbour showed that there is no advantage to revisiting IOL calculations between first and second eye surgeries, Dr. Arshinoff said.

Still, if results do not meet patients’ expectations, or if bilateral infections occur, physicians could be opening themselves up to potential “medical and legal adventures,” Dr. Mackool said.

Dr. Claoué noted that anisometropia is usually predictable after first eye unilateral surgery and that the ensuing visual symptoms can be avoided with SBCS.

Some types of lens surgery are not suited to SBCS, according to Jack A. Singer, MD, who practices in Vermont and has performed SBCS on special cases.

“With the growth of premium lens surgery, I think the future of SBCS in the States will be very limited. Premium lens surgery requires precise IOL power prediction and refinement of IOL power for the second eye based on the outcome of the first eye,” he said.

Dr. Arshinoff, however, said he has observed that multifocal IOL patients are among the happiest SBCS patients and rarely have problems with adaptation to their new vision.

Benefits

While there are risks to SBCS, there are also benefits, according to proponents of the procedure. Dr. Johansson said that patients properly selected for the procedure experience both logistical and visual benefits. For elderly patients, there is the convenience of less travel time for multiple office visits and a reduction in the total time on postop medications. For younger patients, office visits and recovery require less time off from school or work.

All patients benefit from having bilateral vision restored at the same time. Patients who undergo SBCS also benefit from reduced anisometropia and risk of injury associated with separate unilateral operations because of inadequate stereoscopic vision. In a study by Mats Lundström, MD, and colleagues, randomly assigned patients received either same-day bilateral surgery or two surgeries performed 2 months apart.

They found that patients who had surgery in one eye had significantly more problems performing daily activities and worse binocular contrast sensitivity than patients who had bilateral cataract surgery on the same day.

Dr. Arshinoff also reported the same patient satisfaction with SBCS.

Cost savings is another benefit of SBCS. In another study by Lundström and colleagues in 2008, separate unilateral surgery was 14% more expensive than simultaneous bilateral surgery.

“The value for the patient depends on the expected survival time. Longer delay between first- and second-eye surgery and shorter survival time after surgery means higher value for the patient to have [SBCS],” Dr. Lundström said.

Dr. Arshinoff said physicians should heed the cost savings that SBCS provides and be willing to learn the procedure now, before governments learn of the cost savings of simultaneous surgery and require its use.

SBCS study

On the island of Gran Canaria, Spain, a novel approach to SBCS has been undertaken: Four physicians in four clinics have performed SBCS on all patients they see who are candidates for the procedure — so far, 20,000 eyes.

David Pérez Silguero, MD, and three physicians have performed the surgeries. Dr. Pérez Silguero said the group is performing a prospective, randomized clinical study of SBCS on 3,200 eyes to show their results; 1,600 eyes have undergone bilateral surgery and 1,600 eyes have undergone unilateral surgery.

The study, which has not yet been published, demonstrates excellent results for bilateral surgery, Dr. Pérez Silguero said. There have been no cases of bilateral infection.

He said the objective is to show that SBCS is another safe and effective option in the cataract surgeon’s armamentarium. He joined the International Society of Bilateral Cataract Surgeons with the same idea in mind.

“We need to join ourselves internationally, first, to put together the world’s experience and to show the ophthalmological community that what we are doing has been supported by all developed countries and is based on the scientific evidences of thousands of cases,” Dr. Pérez Silguero said.

Reimbursement

In Finland, the rate of SBCS varies widely, but there are some large and mid-size clinics that perform 40% to 60% of cataract cases as SBCS. In 2007, 11.2% of all cataract patients were operated bilaterally. Sulevi Kaipiainen, MD, explained that with public tax-run medical care, which accounts for 85% of all medical care in the country, patients pay a nominal, all-inclusive fee per visit. For SBCS, they have their second eye operation free of additional charge.

In private medical care, social security reimbursement is double after double surgery, he said.

At Dr. Kaipiainen’s hospital in Joensuu, Finland, SBCS has been a routine procedure since 1996. He and colleagues have operated on about 12,500 eyes with SBCS. In Dr. Kaipiainen’s own practice, nearly 70% of his cataract surgeries are simultaneous bilateral procedures.

He and his colleagues have strict criteria for eligible SBCS candidates. Only patients who are not at major statistical risk of severe postop complications receive SBCS. Patients who have extreme myopia, lattice degeneration of the retina, Fuchs’ endothelial dystrophy or chronic skin disease involving the eyelids are contraindicated for the procedure, Dr. Kaipiainen said. In addition, SBCS is not completed if there are problems with the surgery in the first eye.

Dr. Kaipiainen and his colleagues have encountered two unilateral endophthalmitis cases after SBCS but no bilateral infections.

Other health care systems do not reimburse fully for the second eyes in SBCS. According to Dr. Arshinoff, who conducted a study on financial differences of SBCS coverage around the world, health care systems in Japan and Israel offer no coverage for the second eye surgery when performed simultaneously. U.S. physicians only receive half of the reimbursement for the second eye.

I. Howard Fine

This coverage unfairly penalizes U.S. physicians who perform SBCS, especially if simultaneous surgery is warranted, such as in patients who require general anesthesia or must travel, I. Howard Fine, MD, said.

Dr. Fine, who has performed three simultaneous bilateral cases in more than 40 years of surgical experience in the United States, said the reduced cost to the health system that SBCS offers — including fewer office visits for a simultaneous procedure and reduced administration costs — renders the procedure more cost-effective and thus reimbursable.

“It requires the same skill, it has the same risks, it has the same malpractice exposure, and it requires the same personnel and preop evaluations,” he said.

Future of procedure

Some clinicians say the surgery might one day be accepted as common practice for eligible candidates everywhere in the world. That day might not be far off, especially in light of the recent global economic situation and the procedure’s cost-effectiveness.

Other physicians, however, do not see SBCS as becoming the standard way that cataract surgery is performed in the U.S.

“I don’t think it’s going to happen,” Dr. Mackool said. “This is not to disparage those non-U.S. physicians who feel that, yes, there are risks, but they’re small, and the benefit to our patients who travel from many miles away, and problems with medical health care financing is such, that we want to do it this other way. Those are concerns, but because of the safety and efficacy measures … it would seem to me prudent to do them one eye at a time, whenever possible, and in the U.S., it’s possible.”

Dr. Fine noted how LASIK was once performed as a unilateral procedure because of the potential risk of infection and refractive error, but it is now more commonly performed as a bilateral procedure.

“Anything that represents saving health care resources, facilitating the delivery of health care and convenience to patients and for surgeons is going to be something that ultimately catches on,” Dr. Fine said. “When the Medicare tidal wave of baby boomers hits, health care facilities and delivery systems are going to be tightly squeezed to be able to maintain access to care.” – by Erin L. Boyle

In what situations should simultaneous bilateral cataract surgery not be performed?

References:

• Arshinoff SA, Chen SH. Simultaneous bilateral cataract surgery: Financial differences among nations and jurisdictions. J Cataract Refract Surg. 2006;32(8):1355-1360.
• Benezra D, Chirambo MC. Bilateral versus unilateral cataract extraction: advantages and complications. Br J Ophthalmol. 1978;62(11):770-773.
• Endophthalmitis Study Group, European Society of Cataract & Refractive Surgeons. Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. J Cataract Refract Surg. 2007;33(6):978-988.
• Johansson BA, Lundh BL. Bilateral same day phacoemulsification: 220 cases retrospectively reviewed. Br J Ophthalmol. 2003;87(3):285-290.
• Kashkouli MB, Salimi S, Aghaee H, Naseripour M. Bilateral Pseudomonas aeruginosa endoph-thalmitis following bilateral simultaneous cataract surgery. Indian J Ophthalmol. 2007;55(5):374-375.
• Kontkanen M, Kaipiainen S. Simultaneous bilateral cataract extraction: a positive view. J Cataract Refract Surg. 2002;28(11):2060-2061.
• Lundström M, Albrecht S, Nilsson M, Aström B. Benefit to patients of bilateral same-day cataract extraction: Randomized clinical study. J Cataract Refract Surg. 2006;32(5):826-830.
• Lundström M, Albrecht S, Roos P. Immediate versus delayed sequential bilateral cataract surgery: an analysis of costs and patient value [published online ahead of print Sept. 11, 2008]. Acta Ophthalmol. doi: 10.1111/j.1755-3768.2008.01343.x.
• Lundström M, Stenevi U, Thorburn W. Quality of life after first- and second-eye cataract surgery: five-year data collected by the Swedish National Cataract Register. J Cataract Refract Surg. 2001;27(10):1553-1559.
• Ozdek SC, Onaran Z, Gürelik G, Konuk O, Tekin s,en A, Hasanreisog(lu B. Bilateral endophthalmitis after simultaneous bilateral cataract surgery. J Cataract Refract Surg. 2005;31(6):1261-1262.
• Puvanachandra N, Humphry RC. Bilateral endophthalmitis after bilateral sequential phacoemulsification. J Cataract Refract Surg. 2008;34(6):1036-1037.

• Steven A. Arshinoff, MD, FRCSC, can be reached at 2115 Finch Ave. W. #316, Toronto, ON, Canada M3N 2V6; 416-745-6969; fax: 416 745-6724; e-mail: ifix2is@sympatico.ca.
• John Bolger, FRCS, can be reached at Spire Hospital, Ambrose Lane, Sharpenden, Hertz, England AL5 4BP; e-mail: eyeLead@aol.com.
• Charles Claoué, MD, FRCS, can be reached at D.B.C.G., Docklands Business Centre, 10-16 Tiller Road, London, England E14 8PX; 020-8852-8522; fax: 020-7345-5084; e-mail: eyes@dbcg.co.uk.
• I. Howard Fine, MD, can be reached at Drs. Fine, Hoffman & Packer, LLC, at 1550 Oak St., Suite 5, Eugene, OR, 97401; 541-687-2110; fax: 541-484-3883; e-mail: hfine@finemd.com.
• Björn Johansson, MD, PhD, can be reached at the Department of Ophthalmology, Linköping University Hospital, SE-581 85 Linköping, Sweden; 46-13-223068; e-mail: Bjorn.Johansson@lio.se.
• Sulevi Kaipiainen, MD, can be reached at Mattilantie 6, 80260 Joensuu, Finland; 358-400-170958; e-mail: sulevi.kaipiainen@pkssk.fi.
• Mats Lundström, MD, can be reached at Eyenet Sweden, Department of Ophthalmology, Blekinge Hospital, Karlskrona, SE-371 85 Blekinge Sweden; 46-455-735135; fax: 46-455-20133; e-mail: mats.lundstrom@ltblekinge.se.
• Richard J. Mackool, MD, can be reached at Mackool Eye Institute, 31-27 41st St., Astoria, NY 11103; 718-728-3400; fax: 718-728-4882; e-mail: mackooleye@aol.com.
• David Pérez Silguero, MD, can be reached at C/Obispo Rabadán, Nº 18, 5º-9, 35003, Las Palmas de Gran Canaria; Canary Islands Spain; e-mail: dpsilguero@msn.com.
• Jack A. Singer, MD, can be reached at 45 S. Main St., Randolph, VT 05060; 802-728-9993; fax: 802-705-1002; e-mail: jack@singereye.com.
• For more information about the International Society of Bilateral Cataract Surgeons, go to www.isbcs.org.