Comparing Outcomes of Femtosecond Laser-Assisted Cataract Surgery and Conventional Phacoemulsification in a Randomized Controlled Trial.
This protocol compares femtosecond laser-assisted cataract surgery (FLACS) with conventional phacoemulsification cataract surgery (CPCS) for age-related cataract using a standardized randomized trial workflow. A total of 113 patients were allocated 1:1 to FLACS (n = 56) or CPCS (n = 57), stratified by nuclear hardness, and assessed at Day 1, Week 1, Month 1, and Month 3. The protocol specifies eligibility screening, concealed allocation, harmonized perioperative care, predefined intraoperative settings, and masked outcome assessment. Primary and secondary outcomes included corrected and uncorrected distance visual acuity, refractive prediction, corneal endothelial cell density, central corneal thickness, intraoperative energy metrics, and adverse events. FLACS reduced cumulative dissipated energy and effective phaco time and showed better Day 1 visual acuity, smaller early central corneal thickening, and milder anterior chamber inflammation (all P < 0.05). At Month 1 and Month 3, between-group differences in visual acuity, refractive prediction error, absolute prediction error, endothelial cell loss, and complications were not significant (all P > 0.05). The protocol supports reproducible evaluation of early recovery advantages while showing comparable short-term safety for both procedures.