Abstract
BACKGROUND: To figure out the efficacy, effects, safety and patient's subjective perceptions of phacoemulsification with the active-fluidics system (AFS). PATIENTS AND METHODS: This was a prospective, randomized, double-masked, controlled clinical study. Age-related cataract patients were recruited and randomly assigned to the AFS group and gravity-fluidics system (GFS) group in a ratio of 1:1 to have phacoemulsification. Participants were followed up at one day, one week, one month and three months postoperatively (Chinese Clinical Trial Registry, ChiCTR2100044409). RESULTS: The overall included participants were 107 finally. The total aspiration time of the AFS group was significantly less than that of the GFS group (p = .020), while no significant difference existed in cumulative dissipated energy and estimated fluid usage between the two groups. The best corrected visual acuity was significantly better in the AFS group at one day and one week postoperatively (p = .002, p = .038 respectively). The recovery of central corneal thickening and macular superficial vasculature increase was earlier in the AFS group. The central retinal thickness was significantly higher in the GFS group at one month and three months postoperatively (p = .029, p = .016 respectively). The incidence of corneal adverse events was higher in GFS group (p = .035). No serious adverse events occurred in either group. Pain scores and the scores of Cat-PROM5 questionnaire of the AFS group were significantly lower than that of the GFS group (p = .011, p = .002 respectively). CONCLUSION: AFS improves the efficiency, effects, safety and patients' subjective perceptions of phacoemulsification compared with GFS. It is worthwhile to promote its application in cataract surgery.KEY MESSAGESThe active-fluidics system automatically detects and maintains stable intraocular pressure at the set value.The active-fluidics system improves the efficiency, effects, safety and patients' subjective perceptions in phacoemulsification.