Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT

Area of Science:

• Ophthalmology
• Surgical Innovation
• Health Economics

Background:

• Cataract surgery is a prevalent surgical procedure.
• Femtosecond laser-assisted cataract surgery (FLACS) offers automation for key surgical steps.

Purpose of the Study:

• To compare the efficacy and safety of FLACS against phacoemulsification cataract surgery (PCS).
• To evaluate visual acuity, refractive outcomes, and patient-reported measures post-surgery.

Main Methods:

• A multicentre, outcome-masked, randomised controlled non-inferiority trial involving 785 patients.
• Patients were randomised to either FLACS (n=392) or PCS (n=393).
• Primary outcome was uncorrected distance visual acuity at 3 months; secondary outcomes included corrected acuity, safety, and patient-reported measures at 3 and 12 months.

Main Results:

• No significant difference in uncorrected or corrected distance visual acuity was found between FLACS and PCS at 3 or 12 months.
• Two posterior capsule tears occurred in the PCS group; no significant differences in safety or patient-reported outcomes were noted.
• While a statistically significant difference favored FLACS in binocular corrected distance visual acuity, it was not deemed clinically significant. FLACS was associated with higher costs and was not cost-effective.

Conclusions:

• FLACS is non-inferior to PCS regarding visual outcomes at 3 months.
• No significant differences in patient-reported health and safety outcomes were observed at 12 months.
• FLACS is not considered cost-effective compared to PCS.