Research in context
Evidence before this study
Before the FEMCAT trial, evidence showed that femtosecond laser technology applied to cataract surgery provided more precise and reproducible ocular tissue incisions than the current manual phacoemulsification technique and reduced the amount of ultrasound energy delivered within the eye. However, few clinical trials have suggested that the precise incisions and phacofragmentation provided by the femtosecond laser and associated real-time imaging technology could improve postoperative visual and refractive outcomes, or decrease the rate of complications associated with cataract surgery, compared with the current reference standard of ultrasound phacoemulsification. Thus, despite its higher investment costs, the health benefit of the innovative and advanced laser technology for patients remained inconclusive. We searched PubMed, Embase, Scopus, Cochrane Central Register of Controlled Trials, Web of Science, and ClinicalTrials.gov for studies published in English up to Dec 5, 2012, using a combination of the terms “cataract surgery”, “femtosecond laser”, “phacoemulsification”, “laser-assisted cataract surgery”, and “cost-effectiveness”. We found no adequately powered randomised clinical trial assessing the clinical benefit of femtosecond laser cataract surgery (FLACS) for patients. Although the FEMCAT trial was underway, we updated our searches for studies published up to July 30, 2019, and identified a Cochrane meta-analysis that could not determine the equivalence or superiority of FLACS because of a very low certainty of available evidence and unclear risk of bias in included studies. A recent single-centre randomised clinical trial found no significant difference between the two surgical techniques for visual or refractive outcomes, but the trial was not adequately powered for the analysis of safety outcomes and did not provide any cost-effectiveness analysis.
Added value of this study
The FEMCAT trial is the first large-scale, independent, randomised clinical trial comparing the innovative FLACS procedure with phacoemulsification cataract surgery (PCS) as the standard of care in two parallel patient groups of similar size. Additionally, the FEMCAT trial is the first to provide a cost-effectiveness analysis with an incremental cost-effectiveness ratio. Our trial shows, in its large sample including a range of cataract severity grades, that FLACS is not superior to the current practice of PCS and does not provide any additional clinical benefit for patients. FLACS was also more expensive and less effective in our cost-effectiveness analysis. Although the femtosecond laser procedure was not associated with severe adverse events in our trial, the technology did not improve the rate of the most frequent complications that threaten sight, and postoperative visual and refractive outcomes were not different between the two surgical procedures.
Implications of all the available evidence
The FEMCAT trial was designed to analyse all clinically significant outcomes related to cataract surgery, which is one of the most common operations in health care, and to minimise the risk of bias observed in previously published trials comparing the two surgical techniques. By showing that FLACS is not superior to PCS and is not a cost-effective strategy for the French health-care system, the results of our trial provide robust and useful information for patients in terms of personal health benefits, and for health-care providers and decision makers in considering the implementation of this new and costly technology in routine practice. Further development and studies to improve the femtosecond laser technology are needed, so that it can provide meaningful visual and health benefits for patients and reduce the increasing burden of cataract surgery by achieving a sustainable cost for health-care systems.