Abstract
PurposeTo report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).DesignMulticenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).ParticipantsSeven hundred eighty-five patients with age-related cataract.MethodsThis trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.Main Outcome MeasuresWe enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was −0.01 logMAR (−0.05 to 0.03), and mean corrected distance visual acuity difference was −0.01 logMAR (95% confidence interval [CI], −0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.ConclusionsFemtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.
Highlights
353 (90%) of 392 participants allocated to Femtosecond laser-assisted cataract surgery (FLACS) and 317 (81%) of 393 participants allocated to phacoemulsification (ultrasound) cataract surgery (PCS) attended their follow-up visit at 3 months
Analysis of toric intraocular lens (IOL) use by arm showed 22 toric lenses were used in the FLACS arm (369 monofocal, 1 data missing), and 19 toric lenses were used in the PCS arm (370 monofocal, 4 data missing)
We found no significant difference between groups for unaided distance visual acuity (UDVA) or any of the prespecified secondary outcomes
Summary
We aimed to recruit at least 808 patients (404 per arm)
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