EUNetHTA: Rapid assessment of femtosecond laser-assisted cataract surgery (FLACS) for the treatment of age-related cataract

Femtosecond lasers have been used to perform several stages of phacoemulsification cataract surgery since 2009. Laser-generated pulses of highly focused infrared light perform the cutting by creating localized cavitation bubbles within tissues, a process termed photo-disruption. The ultrashort duration of each pulse minimizes damage to adjacent tissue. During cataract surgery, these lasers are used to create incisions, perform capsulorhexis and fragment the lens. The surgeon plans and decides the target location; then the system delivers the focus of the laser beam to Femtosecond Laser-Assisted Surgery (FLACS) for the age-related cataract to produce the desired incision. The procedure is then completed using conventional phacoemulsification equipment and techniques. The femtosecond laser was initially introduced to create corneal flaps for laser in situ keratomileusis (LASIK). It is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

FLACS systems claim to provide several advantages to the surgeon, such as the performance of very precise circular and adjustable diameter capsulotomies, precise lens nucleus fragmentation, the creation of multi-planar self-sealing incisions with better wound architecture, the exact placement of limbal relaxing incisions and the reduction of phacoemulsification time. MTRC wrote about the plan of this project in March (see here).

Thus, the authors’ aim was to compare the effectiveness and safety of FLACS compared to the standard cataract surgery.

The authors have performed a systematic review of the literature according to the Cochrane Handbook methodology. Only the publications published in the period January 2016 – December 2017 were considered. The following websites were searched: CENTRAL, Embase, Medline, Scopus, Cochrane Database of Systematic Reviews (CDSR), Centre for Reviews and Dissemination (CRD) Databases, but also various clinical trial websites to identify ongoing studies. Eventually, the authors used 21 RCTs (out of which 15 were meta-analyses) for developing the report. These publications provide a sample of 1633 patients (2118 eyes).

Effectiveness

The outcomes assessed were Corrected Distance Visual Acuity (CDVA), Uncorrected Distance Visual Acuity (UDVA), at 1 month and 6 months after the intervention. Regarding CDVA at 1 month after surgery, all but one study (6/7), which favoured FLACS, did not demonstrate the statistically significant difference between the FLACS and the conventional intervention. The same can be deduced for CDVA at 6 months after the intervention (3/4 studies). Regarding UDVA at 1 month after surgery, 3/4 studies found no statistically significant differences between FLACS and standard intervention, while only one favoured FLACS. The conclusion is the same when considering UDVA at 6 months. One study endorsed FLACS in terms of refractive outcomes, while one study showed no significant differences. No studies assessed the quality of life, but one Austrian study showed that 57% of patients would rather recommend the traditional surgery, compared to FLACS.

Safety

No differences in the included studies were identified regarding the intraoperative and postoperative complications.

The authors have noted that the quality of the studies included is rather poor. The authors’ conclusion is that there is insufficient evidence to determine whether FLACS leads to any improvement compared to standard cataract surgery in terms of effectiveness, safety or organization of care.

See the full report in English here.

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