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March 04, 2021
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Surgeons address pros, cons of immediate sequential bilateral cataract surgery

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Immediate sequential bilateral cataract surgery can provide comparable outcomes and efficiencies as traditional cataract surgery, but until reimbursement rates are modified, it may not become widespread.

Immediate sequential bilateral cataract surgery (ISBCS) reduces patient visits to the operating room and has outcomes comparable to traditional delayed sequential bilateral cataract surgery, OSN Cornea/External Disease Section Editor Elizabeth Yeu, MD, said.

“I’m a huge advocate of same-day immediately sequential bilateral cataract surgery. We’ve gotten to a point where we’ve optimized safety for this procedure, and peer-reviewed evidence shows there is no increase in risk as long as you’re taking your normal precautions. From the standpoint of efficacy, especially for routine, noncomplex cataract surgeries, patients definitely enjoy the opportunity to limit their number of postoperative visits,” she said.

Elizabeth Yeu, MD
Same-day bilateral cataract surgery ‘makes sense’ in this era of social distancing, according to Elizabeth Yeu, MD.

Source: Elizabeth Yeu, MD

In the current COVID-19 climate, efforts are being made to limit patient visits to the clinic. Routine cataract surgeries require a postoperative day 1 visit, additional postoperative evaluations and a second surgery once the first eye is healed. A patient is required to make several trips to the clinic in a climate in which social distancing is encouraged, Yeu said.

“We’re already limiting patients from coming back to the clinic. We’re thinking of ways to eventually move in the direction of limiting operating room visits as well, so same-day bilateral cataract surgery makes sense,” Yeu said.

Yeu said about 1% to 5% of her monthly cataract surgeries are ISBCS procedures. Ideal candidates are those who must undergo general anesthesia, have trouble traveling, or have significant comorbidities such as being wheelchair-bound or having Parkinson’s disease, Alzheimer’s disease or other cognition-related comorbidities.

ISBCS is even appropriate in patients who have bigger cataracts or smaller pupils, as long as the first eye encounters no complications or difficulties during the procedure. If a patient is expected to fall within the 94% of patients who will be within 0.25 D to 0.5 D of predicted refractive error, ISBCS is an appropriate option, she said.

Monetary and productivity advantages

Hospitals and ASCs can realize monetary and productivity advantages when offering ISBCS. In a 2021 editorial published in Ophthalmology by Ike K. Ahmed, MD, FRCSC, and colleagues, studies in the United Kingdom and Canada showed a 32.4% reduction (P < .0001) in hospital cost when performing ISBCS compared with traditional delayed sequential bilateral cataract surgery (DSBCS).

In the era of COVID-19, extra spacing, cleaning and time between patients are required, which increase costs. Patients must also account for increased costs for travel, family and caregiver time, missed work and extra postoperative visits when undergoing DSBCS. ISBCS has greater cost efficiency, reduces personal protective equipment use and provides faster binocular recovery of vision compared with DSBCS, Ahmed and colleagues wrote.

A 2015 study published in Journal of Cataract and Refractive Surgery compared visual and economic benefits of 42 ISBCS patients and 42 DSBCS patients. Same-day patients experienced fewer visits, less time traveling for care and less time for vision recovery compared with delayed patients. However, ASC expenses were higher in the ISBCS cohort, and third-party payer cost was significantly less in the same-day cohort, according to the study.

Reimbursement barriers

Reimbursement for ISBCS is a main hindrance of widespread adoption in the U.S. The second eye is reimbursed at a rate of only 50% compared with the first eye, Yeu said.

“There needs to be an alternative payment model system. The closer that the reimbursement is to 100% of the first eye, the better, of course. Fee for service, especially at this time if we can get some kind of CMS emergency protocol through, where it would allow for even 80% for the second eye, would make sense, as costs would be offset. Such costs include anesthesia medications and disposables, like the IV. There is a time-saving component with ISBCS, but unless that 50% for the second eye is adjusted upward to some degree, there’s no way it’s going to be feasible,” she said.

The 2015 JCRS study found a net loss of $407 for the second eye of an ISBCS for an ASC due to the 50% reimbursement. The study found the only identifiable cost reduction for ISBCS for an ASC was that one set of bed sheets was used and only one IV line had to be started in cases in which IV sedation was used.

Due to the current reimbursement structure, the surgeon takes on the majority of the risk when ISBCS is performed. Third-party payers, such as private and public insurance carriers, are the main beneficiaries and see the most substantial cost reductions, Eric D. Rosenberg, DO, MSE, of SightMD, said.

“These payers are the ones netting the most amount of savings by doing same-day cataract surgery, even with the decreasing number of primary care visits and one less surgery,” Rosenberg said.

For ISBCS to be more economically viable for surgeons, third-party payers need to enact changes to the reimbursement infrastructure. The procedure needs to be “merely equivocal” for surgeons to use it more for patients who may benefit, he said.

Potentially devastating complications

A separate concern for ISBCS is the risk for bilateral endophthalmitis, a rare but devastating complication, Healio/OSN Section Editor Uday Devgan, MD, said.

Uday Devgan, MD
Uday Devgan

The risk is small, but the complication is the “ultimate nightmare” for a patient and surgeon. It is not much of an issue for traditional delayed cataract surgery, he said.

However, rates of bilateral endophthalmitis in ISBCS are low, as shown in a 2011 Journal of Cataract and Refractive Surgery study. The cohort study evaluated incidence of endophthalmitis after ISBCS and found no bilateral simultaneous endophthalmitis occurrences in 95,606 cases collected.

The overall rate of postoperative endophthalmitis after ISBCS was one in 5,759, but overall infection rates were significantly reduced to one in 14,532 cases when intracameral antibiotics were used, according to the study.

Common sense precautions can drastically reduce infection and complication rates during ISBCS. Treating each eye as a separate patient with new instruments, new drapings and new medications is routine during ISBCS, Devgan said.

“Even when you take all precautions, there is a risk for patients to develop bilateral endophthalmitis after surgery. It is a risk you’re going to take, but it is very tiny,” Devgan said.

The risk for complications during ISBCS can be reduced if surgeons follow the “general principles of excellence” set forth by the International Society of Bilateral Cataract Surgeons, Healio/OSN Board Member Jason P. Brinton, MD, said.

Brinton said his practice has offered ISBCS to eligible patients since 2014. Reimbursement has never been an issue because all of his procedures are on a cash-pay basis.

Jason P. Brinton, MD
Jason P. Brinton

“As with LASIK, our St. Louis refractive lens exchange patients usually prefer to have their eyes corrected on the same day. It’s more convenient for the patient, their family, their workplace and their driver, and it provides faster visual recovery. For the majority of our patients who are healthy and whose only issue is refractive error, ISBCS is our standard, go-to approach,” he said.

Principles for excellence

Brinton, a member of the international society who helped develop the guidelines, said they hold bilateral cataract surgeons to a higher standard due to the risk for bilateral endophthalmitis or toxic anterior segment syndrome (TASS).

Patients with a history of eye pathology or systemic conditions that increase the chances of a complicated postoperative course are not ideal candidates for ISBCS. For example, in patients with diabetes or an autoimmune condition, delaying the second eye surgery is usually recommended.

“As far as we know, worldwide, as long as bilateral IOL surgery standards have been followed, there have been no cases of bilateral endophthalmitis or TASS. When questionable cases have arisen, investigations have subsequently shown that guidelines were not followed. Maybe they didn’t use separate sterile setups or used the same intracameral medication for both eyes. From a probability standpoint, following proper precautions lowers the risk of a bilateral complication from the sum of the unilateral risks to the product of the unilateral risks, which is significantly lower,” he said.

The guidelines for ISBCS developed by the committee said patients should be indicated for cataract or refractive lens surgery in both eyes. Relevant ocular or periocular disease should be managed before surgery to ensure success.

Only surgeons who can competently perform ISBCS should undertake the procedure, and patients should provide informed consent for ISBCS, according to the guidelines.

All surgical parameters should be listed for both eyes to minimize risk at the beginning of each case. IOL power errors can be minimized by having operating room personnel familiar with the calculation methods, and all personnel should confirm the IOL choice.

Separation of all materials for the first and second eye surgeries is mandatory to minimize the risk for postoperative bilateral simultaneous endophthalmitis. The entire operating room must be redone for the second eye, everyone must re-sterilize, and all new lots of materials must be brought in to ensure safety, Thomas A. Oetting, MS, MD, ophthalmology residency program director for the department of ophthalmology and visual sciences at the University of Iowa, said.

“You need to be confident that the surgery you’re performing is absolutely as safe as possible. To prepare for bilateral cataract surgery, we needed to revise a few of our procedures to stay within the guidelines,” he said.

Oetting said ISBCS is the preferred surgical procedure at the Iowa City VA Health Care System due to the reduction of patient visits and travel. To prepare for ISBCS, Oetting changed surgical protocols to include the use of intracameral antibiotics and sealant instead of sutures.

The society recommended any complication with the first eye surgery must be resolved before proceeding with the second eye. In addition, safety and patient benefits must be confirmed before moving on. Finally, patients should not patch and should receive postoperative drops six times a day for the first 4 days beginning 1 hour postoperatively, then four times a day until the drops are gone.

Safety reduces complication risk

If the guidelines are followed, the risk for developing bilateral endophthalmitis and TASS are minimal. Data have been presented showing patients are more at risk of dying driving back to the hospital for a postoperative visit than they are of developing bilateral endophthalmitis, Oetting said.

A 2010 letter published in Eye (London) calculated the road accident risk for patients undergoing traditional cataract surgery compared with ISBCS. The authors calculated each ISBCS patient must undergo four clinical appointments compared with six clinical appointments for traditional cataract patients. Data show the average round trip per hospital appointment is 56 miles, leading to a total of 224 miles traveled per ISBCS patient compared with 336 miles per traditional cataract patient.

Data show 1.48 road fatalities per 1 million miles of road traveled. The authors wrote this would lead to a total of 1.66 deaths on the road per 500,000 patients undergoing ISBCS compared with 2.49 deaths for the same number of traditional cataract patients. This increased to 2.9 deaths if these traditional patients have a second assessment between surgery.

More studies needed

While risk for endophthalmitis and TASS is low, more expansive studies showing safety and efficacy should be published to make the procedure more appealing for surgeons, Rosenberg said.

Large-scale studies showing bilateral endophthalmitis and TASS risk are difficult to organize and conduct due to their required size. Several studies have been published comparing visual acuity between the two procedures, but often the traditional cataract surgery is not completed in real time, with the second eye being operated on 2 to 3 months later, Rosenberg said.

Surgeons need to clearly explain to patients about what they can expect after ISBCS and what their postoperative vision can and cannot do. Even with a clear explanation, patients will not be able to understand how a lens affects their vision until after a surgery, which can be a risk with ISBCS, Rosenberg said.

“I can sit there in clinic and explain to a patient about what they can expect until I’m blue in the face and about what these lenses can and cannot do. But the ultimate downside to this is they don’t get to experience the effect on their vision until after their surgery. If a patient is not satisfied with their vision after ISBCS, you may find yourself going back and doing a bilateral IOL exchange,” Rosenberg said.

Technology improves ISBCS

But as technology improves, the traditional course of modifying the second eye based on the results of the first eye is no longer gospel, Oetting said.

Most surgeons do not do this currently, as the refraction from the first eye is rarely set before the second is operated on. Intraoperative aberrometry with the ORA system (Alcon) can provide real-time readings to help the surgeon make a best choice for IOL power and astigmatism correction, Oetting said.

The expanded use of Light Adjustable Lenses (RxSight) could also make ISBCS more commonplace. A bilateral Light Adjustable Lens requires less time for a patient to protect their eyes during the period where they are setting. The second eye does not have to be adjusted based on the results of the first eye, he said.

“Light Adjustable Lenses may be the technology that really pushes people to adopt immediately sequential bilateral cataract surgery,” Oetting said.

There are other hurdles outside of reimbursement that need to be addressed for wider adoption of ISBCS. Better IOL formulas and diagnostic technologies have made this a potentially preferable approach for eligible patients, Yeu said.

Postoperative and perioperative medicines may need to be adjusted if ISBCS becomes more widespread. It is more difficult to complete one eye and keep everything separate and sterile with postoperative drops.

“Completing two eyes will be even more challenging. I do suspect that the more modern approaches to perioperative medicine, whether it’s an intracameral or intracanalicular approach where we can minimize topical drops, will be extremely important,” Yeu said.

ISBCS is a good approach to the changing climate of cataract surgery and ophthalmic care. Even as vaccinations become more widespread and COVID-19 lessens, there will always be a level of social distancing recommended in clinical settings. Reducing clinic visits and operating room trips will be necessary.

“I don’t believe we’ll go back exactly to the way it was. I think social distancing patients within the clinical settings will be a must for a while, and there will always be a need to limit the amount of people in a building. Immediately sequential bilateral cataract surgery can make this happen,” Yeu said.

Click here to read the Point/Counter to this Cover Story.