The US View on EUREQUO

In the February issue of The Ophthalmologist, we interviewed Peter Barry, past president and current board member of the ESCRS, about the European Registry of Quality Outcomes in Cataract and Refractive Surgery (EUREQUO) database (1). Established in 2006, EUREQUO allowed clinics all over Europe to enter their cataract and refractive surgery data into a registry, anonymously, so that they could compare their surgical outcomes with those of their national and European peers. During his presidency, Peter decided to use the EUREQUO dataset to compare the outcomes of patients who received femtosecond laser-assisted cataract surgery (FLACS) with the outcomes of patients who underwent traditional manual capsulorhexis and phacoemulsification. What did his search find? There was no real difference in surgical outcomes between the two methods.

But EUREQUO is very much a European registry – do the findings translate to other countries that have seen substantial uptake of the femtosecond laser, like the US? We asked two expert cataract surgeons from across the pond, David Chang and Mitchell Jackson, to share their thoughts.

Can you describe a typical day in your practice?

David Chang: I perform 200 cataract surgeries per month. Alternating between two rooms, I’ll perform 30–32 cases per day. I schedule the most time-consuming and complicated cases at the end of the day.

Mitchell Jackson: I perform 100-125 cataract surgeries per month. I schedule the most difficult cases at the end of the day, or on a separate day of just a few complex cases only.

What’s your standard procedure for cataract removal/ IOL placement?

DC: I perform manual phaco exclusively. We have never had a femtosecond laser at our surgery center because we wanted to first be convinced that the benefits would justify the substantial costs that would need to be passed on to our patients.

MJ: I perform 100–125 cases per month, the vast majority of which (89–92 percent) are FLACS, and are all done in same room with femto in the OR. This maximizes our efficiency, and we average 25–30 cases/day. We also use the intraoperative aberrometer in the same room in up to around 56–63 percent of cases.

What particular advantages do your methods convey?

DC: I am very comfortable with manual continuous curvilinear capsulorhexes and with phaco chop, regardless of the case complexity. In the US, we are not allowed to charge Medicare patients out of pocket for any technology or instrumentation used to perform cataract surgery. We are allowed to charge Medicare patients for astigmatic keratotomy and for the OCT imaging component of the technology, “if the surgeon believes that this imaging will improve the refractive outcome.” I use Alcon’s ORA intraoperative wavefront aberrometry for refractive cataract cases, which includes toric and multifocal IOLs, LRIs, and post-LASIK eyes. I use the Zeiss Callisto eye system to mark the astigmatic axis intraoperatively. Although they add time, these two complementary technologies improve my refractive outcomes for these cases. However, I do not believe that femtosecond laser imaging or capsulotomy would have any further refractive benefit. I cannot justify using and charging my patients for this as a means of improving refractive outcomes.

MJ: CMS rulings allow for charging Medicare patients for the astigmatism management and OCT digital imaging component of FLACS. But the real benefits from FLACS come from precise capsulotomy, which has been proven and published to yield more accurate effective lens position (ELP) postoperatively, and customized capsulotomies based on pupil or optical axis (the latter being my preference when using multifocal IOL implants). Further, Burkhard Dick has many publications showing that using femtosecond laser to pre-fragment the nucleus significantly reduces effective phaco time. My own data (presented at ASCRS 2015 and at ACES SEE 2016) shows significant reductions in EPT FLACS with LENSAR and Stellaris phaco microburst technology combined. I find ORA intraoperative aberrometry system useful for aphakic IOL power determination, especially in post laser vision correction patients (LASIK, PRK) and for pseudophakic axis placement in toric IOL cases.

Are there any situations where you feel femtosecond lasers might be a better choice for capsulotomy, or is your preference for manual tools universal?

DC: I understand the preferences of some surgeons to use the femtosecond laser with certain complicated eyes, such as white cataracts. However, these cases are uncommon and we are not able to legally pass the substantial per-case charges on to our American Medicare patients. In addition, the infrequency of these cases would not justify the significant economic and workflow costs of having and maintaining a femtosecond laser.

What are your views on the EUREQUO study design and results?

DC: The advantage of this study is that it compares very large numbers of patients over an extended postoperative period. There was no industry sponsorship and no reporting bias, because the results were going to be presented regardless of what was found.

An acknowledged weakness of any registry-based study is the lack of prospective randomization. Because of this, the investigators made a diligent effort to match the two study populations – including age, preoperative acuity, and co-morbidities. It was certainly notable that the femtosecond laser patient population had statistically higher postoperative complication rates. Because of the study design limitations, this doesn’t conclusively prove that femto is inferior or riskier than phaco. However, it clearly dispels marketing claims by some American surgeons that laser cataract surgery is a major advance or superior to the non-laser methods. Such public advertising has unjustifiably left many non-femto cataract patients feeling short-changed. The EUREQUO study provides some of the strongest evidence to date that such broad claims of superiority are misleading and wrong.

If you look at the FLACS surgeon group in the EUREQUO study, you’ll see that they are all top cataract surgeons within their respective countries. It is the European femto surgeon “all-star” team! I would have expected this elite group of experienced surgeons to have superior collective outcomes compared against the broad universe of community ophthalmologists from the registry. I was impressed that even when armed with this cutting edge technology, the top femto surgeons in Europe and Australia did no better – and by some parameters worse – than the registry surgeons using manual phaco. To me, this was a striking finding.

MJ: This study is registry-based and lacks prospective randomization, and in my opinion is not a valid enough study to make a claim that FLACS is inferior or riskier than manual phaco alone. In my hands, in over 1,000 FLACS cases, EPT was statistically reduced, astigmatism was managed with excellent visual outcomes of up to 1.5 D cylinder preoperatively, using iris registration on the Cassini topography linked via Streamline to LENSAR. Corneal edema was less on postoperative day one (enhancing a patient’s “wow” factor and likelihood to refer more patients), and I did not have as high a postoperative complication rate as the EUROQUO study claims. I believe a true comparative prospective study needs to be performed matching age, technology used, and co-morbidities in a large series in the United States.

What do you say to patients who specifically request the femtosecond laser?

DC: I explain that the preponderance of studies has been unable to show any benefit. Otherwise, we would have it and would let our patients decide if they wanted to pay the extra costs.

MJ: Basically, I would agree with them. Luckily, I would not need any extra chair time preoperatively to convince the patient of the need for FLACS.

What improvements would you like to see made to femtosecond laser technology?

DC: There are several exciting technologies such as CAPSULaser and Zepto that automate the capsulotomy step without click fees. I am a consultant and investigator for Mynosys on their Zepto device, which is a disposable instrument that uses nanopulse technology to achieve a perfect capsulotomy without cautery. Zepto would be used in the normal surgical sequence and may be able to automate creation of a precise diameter capsulotomy without the high costs and workflow inefficiency of the femtosecond laser – making it available to most cataract patients.

MJ: I want to downplay the misconception by most non FLACS surgeons that there are workflow inefficiencies using femtosecond laser technology. Sure, it could be faster, but having the LENSAR in the OR, we are able to perform 25–30 cases per day without any real workflow issues after the one-day learning curve that was needed to incorporate femtosecond technology into our practice. With the use of Streamline iris registration for astigmatic management, there is no need for marking (which saves time), and with the lens fragmentation, EPT is reduced (which saves time). And in more complex cases, such as prior trauma, dense nuclear cataracts, and pseudoexfoliation cases, fragmentation makes phaco less risky in terms of EPT and vitreous loss (which saves more time). In reality, femtosecond laser technology has made my surgery days more workflow efficient.