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Day AC, Burr JM, Bennett K, Bunce C, Doré CJ, Rubin GS, Nanavaty MA, Balaggan KS, Wilkins MR, FACT group. Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial. Ophthalmology. 2020;127:1012-1019. PMID 32386810

One-paragraph summary

FACT randomised 785 patients with age-related cataract at three UK NHS hospitals between May 2015 and September 2017 to femtosecond laser-assisted cataract surgery (FLACS, n = 392) or standard phacoemulsification (PCS, n = 393), stratified by site, surgeon and one-or-both-eyes eligibility, with postoperative assessment masked to allocation and a non-inferiority margin of 0.1 logMAR. At three months the difference in unaided distance visual acuity was −0.01 logMAR (95% CI −0.05 to 0.03) and in corrected distance acuity −0.01 logMAR (−0.05 to 0.02). Seventy-one percent of eyes in both arms were within ±0.5 D of refractive target and 93% (FLACS) versus 92% (PCS) within ±1.0 D. There were two posterior capsule tears in the PCS arm and none in the FLACS arm, and no significant difference in any secondary outcome. The trial registration is ISRCTN77602616; the full health-technology assessment including 12-month and economic outcomes was published separately (Day 2021, PMID 33511963).

Key findings

  • Unaided distance acuity at 3 months: difference −0.01 logMAR (95% CI −0.05 to 0.03), non-inferior.
  • Corrected distance acuity: −0.01 logMAR (−0.05 to 0.02).
  • Refractive accuracy identical: 71% within ±0.5 D in both arms.
  • Posterior capsule tears: 2 (PCS) vs 0 (FLACS) — too few to interpret.
  • No significant difference in any patient-reported or safety secondary outcome.

Limitations

  • Three-month primary endpoint; late outcomes such as posterior capsule opacification are not addressed.
  • Powered for acuity, not for rare intraoperative complications — which is precisely where the laser's advocates locate the benefit.
  • Routine age-related cataract only; the cases in which FLACS is now argued to help (hard nuclei, white cataract, shallow chamber, posterior polar cataract) were not the trial population (Chen 2026, PMID 41679368).
  • Non-inferiority design cannot demonstrate superiority of PCS, only the absence of FLACS superiority above the margin.

Why it matters

FACT and the French FEMCAT trial (Schweitzer 2020, PMID 31954466), published within months of each other, closed the routine-case question from two directions: FACT showed non-inferiority on the patient-facing endpoint, FEMCAT failed to show superiority on a composite success endpoint (41.1% vs 43.6%; adjusted OR 0.85, 95% CI 0.64–1.12) with an incremental €10,703 saved per additional success using conventional phacoemulsification. The Cochrane review of 42 RCTs and 7,298 eyes subsequently found low-certainty evidence of about four fewer posterior capsule tears per 1,000 operations and a clinically unimportant one-letter acuity advantage, while noting that 16 of 42 trials reported financial links with the laser manufacturer and 13 paired-eye studies were analysed ignoring pairing (Narayan 2023, PMID 37369549). NICE's position — use FLACS only within a randomised trial collecting resource-use data — follows directly (NICE NG77 recommendation 1.6.1, accessed 2026-08-31).

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