A prospective randomized clinical trial of active-fluidics versus gravity-fluidics system in phacoemulsification for age-related cataract (AGSPC)

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 MESSAGES The 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.

Application of the Active-Fluidics System in Phacoemulsification: A Review

“…The effect of PKE on retinal structure and function has also been the focus of recent research. Increases in retinal thickness (RT) and retinal vessel density (VD) after PKE have been observed, and such changes are closely related to surgical injuries, IOP changes and inflammatory reactions [ 30 , 31 , 42 , 43 , 44 ]. Comparisons between the AFS and GFS on this topic may reveal some potential mechanisms.…”

“…No significant difference has been yet reported between the AFS and GFS in terms of other surgical complications. Randomized controlled studies reported no significant difference in the incidence of adverse events such as allergic conjunctivitis, ocular congestion, dry eye, and posterior vitreous detachment after PKE with each of the two fluidics systems, and none had other serious complications [ 7 , 29 , 31 ].…”

“…However, the outcomes of different studies were not entirely consistent, with reports of CDE savings from the AFS ranging from 13.5% to 40% [ 7 , 27 , 29 ]. There were also reports of no significant difference in the comparison of CDE [ 31 , 47 ]. The reason behind this is that many factors affect the surgery efficiency, including the fluidics system, surgical techniques, needle tips, the vacuum value, and so on.…”

“…The postoperative best corrected visual acuity (BCVA) is one of the most important indicators to assess the outcome of cataract surgery, which is closely related to the patient’s primary visual functions and surgical injuries. Some clinical studies demonstrated that BCVA in the early postoperative period (1 day and 1 week) was better when PKE was performed with the AFS than with the GFS [ 31 , 47 , 51 ]. This advantage did not vanish until 1 month postoperatively [ 8 , 38 , 47 ].…”

“…The maintenance of AC stability and the ability to combat surges provided by AFS can improve surgical safety and efficiency and also allows for a low target IOP to be set (40–50 mmHg). If the target IOP is closer to the physiological status, patients’ discomfort can be greatly reduced and the surgery can be better coordinated [ 9 , 15 , 31 ].…”