FEMCAT trial fails to show clinical benefit of FLACS over standard phaco

Roibeard O’hEineachain

Posted: Saturday, June 6, 2020

Cédric Schweitzer MD

Femtosecond laser-assisted cataract surgery (FLACS) is neither safer nor more effective than standard ultrasound phacoemulsification and is considerably less cost-effective, according to the findings of the largest prospective randomised controlled trial conducted to date comparing the two procedures, published in the January 2020 issue of The Lancet.
“The main point to take home from this study is that FLACS is a very safe procedure because we didn’t observe any significant adverse event related to the laser procedure by itself, but on the other hand, the advantages proposed for this advanced technology does not translate into any clinical benefit for patients compared to standard phacoemulsification,” the study’s lead investigator Cédric Schweitzer MD, Bordeaux University Hospital, France, told EuroTimes in an interview.
The Femtosecond laser-assisted versus phacoemulsification Cataract surgery (FEMCAT) trial involved 1,476 eyes of 907 patients who were randomly assigned to undergo bilateral cataract surgery either with FLACS with the Catalys® system (Johnson & Johnson) or standard phacoemulsification between Oct 9, 2013, and Oct 30, 2015. Participants were masked to the surgical treatment allocation until the last follow-up visit at 12 months after surgery. Those in the phacoemulsification group underwent a sham laser procedure.
The primary clinical endpoint was the success rate of surgery, defined as a composite of four outcome criteria at a three-month postoperative visit: absence of severe perioperative complication, a best-corrected visual acuity (BCVA) of 0.0 LogMAR or better, an absolute refractive error of 0.75 D or less and 0.5 D or less change in corneal astigmatism and 20°or less change in cylinder axis.
On that basis the study’s investigators found no significant difference in the success rate of surgery between the FLACS group (41.1%) and the standard phacoemulsification (43.6%). The incremental cost-effectiveness ratio was €10,703 saved per additional patient who had treatment success with PCS compared with FLACS. At the same time there no significant differences between the two groups in terms of complications. Most of the complications in the FLACS group occurred during the phacoemulsification phase of the procedure or post-operatively.
“The cost-effective ratio of phacoemulsification surgery is one of the best in medicine, whatever the specialty. Surgeons can choose to use the femtosecond laser, but it is too costly. If the costs were similar or there were improvements in the technology that could a provide greater clinical benefit to patients, perhaps related to new intraocular lenses, as was the case with foldable IOLs and phacoemulsification, we could change the paradigm,” Dr Schweitzer said.

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