A randomised controlled trial comparing femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery: 12-month results.

Aims: To report 12-month outcomes of randomised controlled trial comparing conventional phacoemulsification surgery (CPS) with femtosecond laser-assisted cataract surgery (FLACS).

Methods: This was a single-centre, prospective single-masked randomised case-controlled trial. Four hundred patients were randomised to CPS or FLACS with the LenSx platform (Alcon Laboratories Inc.). Visual acuity, refraction, central corneal thickness, endothelial cell loss (ECL), adverse events and quality of life outcomes, using EuroQOL 5-dimensions (EQ-5D-3 L) and cataract surgery patient-reported outcome measures (PROMs) questionnaires (Cat-PROM5), were recorded.

Results: Two hundred and thirty four patients (58.5%) attended 12-month follow-up (116 FLACS, 118 CPS). Mean LogMAR unaided distance visual acuity) (±SD) was 0.12 (0.18) with FLACS and 0.13 (0.19) with CPS (p=0.68; 95% Confidence Interval [CI]-0.06,0.04). Mean spherical equivalent (SE) refraction was -0.1±0.6 diopters (D) with FLACS and -0.2±0.6 D with CPS (p=0.44; 95% CI -0.09, 0.21). Mean corrected distance visual acuity (±SD) was -0.01 (0.1) with FLACS and 0(0.1) with CPS (p=0.45; 95% CI -0.04,0.02). Two patients per group underwent YAG laser capsulotomy for posterior capsular opacification (p=1). Mean ECL (per mm±SD) was 301±320 with FLACS and 228±303 with CPS (p=0.07; 95% CI -7.26, 153.26). Mean Cat-PROM scores (±SD) were -5.5 (2.6) with FLACS and -5.8 (2.5) with CPS (p=0.3; 95% CI 0.31,1.01). EQ5-3DL mean index score (±SD) was 0.92 (0.13) with FLACS and 0.89 (0.14) with CPS (p=0.1; 95% CI -0.1, 0.01). Vector analysis comparing manual limbal relaxing incisions (LRIs) and intrastromal femtosecond laser-assisted astigmatic keratotomies (iFAKs) showed a greater correction index (p=0.02; 95% CI 0.06 to 0.60) and smaller difference vector (p=0.046; 95% CI -0.54, -0.01) with iFAK.

Conclusions: There were no differences in vision, refraction, adverse postoperative events or PROMs between FLACS and CPS groups at 12 months. iFAKs may provide more effective astigmatic correction compared to LRIs, 12 months postoperatively.