Three-Dimensional Heads-up Cataract Surgery Using Femtosecond Laser: Efficiency, Efficacy, Safety, and Medical Education—A Randomized Clinical Trial

Abstract

To compare the efficiency, efficacy, and safety, as well as the educational value, of heads-up (three-dimensional visualization system-assisted) and traditional microscopic cataract surgery.Methods: This randomized noninferiority trial enrolled 242 eyes of 201 patients who received femtosecond laser-assisted cataract surgery. The questionnaire study enrolled 26 medical interns and 39 medical students. Patients received surgery under either a three-dimensional visualization system (3D group, 117 eyes) or traditional microscope (TM group, 125 eyes) after random allocation. The primary outcome was surgical time. The noninferiority margin of surgical time was 60 seconds. Secondary outcomes included ultrasound power, phacoemulsification time, visual acuity, intraocular pressure, endothelial cell density, central corneal thickness, complications, and observer satisfaction scores for surgical procedures.Results: Surgical time was 462.03 ± 80.36 seconds in the 3D group and 452.13 ± 76.63 seconds in the TM group (difference 9.90 seconds; 95% CI, -9.98 to 29.78; P = 0.365). Visual acuity and other perioperative parameters were comparable between the 3D group and the TM group (all P > 0.05). Incidences of both intraoperative and postoperative complications were low and not statistically different between groups (all P > 0.05). Across all observers, 3D surgery was superior to TM surgery for improving the degree of satisfaction (all P < 0.001). Conclusions:The surgical efficiency of heads-up cataract surgery is not inferior to traditional microscopic surgery. Both methods achieved similar efficacy and safety outcomes. Moreover, heads-up cataract surgery showed a significant advantage in medical education.Translational Relevance: Our findings show that heads-up cataract surgery has comparable efficiency, efficacy, and safety, as well as superior medical educational value, to TM surgery, which lays the foundation for promoting and popularizing this technology.

Three-Dimensional Heads-Up vs. Standard Operating Microscope for Cataract Surgery: A Systematic Review and Meta-Analysis

“…Finally, a total of 11 studies of 11 articles (8842 eyes) met the inclusion and exclusion criteria and were included in the systematic review and meta-analysis. Notably, nine studies were included in the meta-analysis of postoperative BCVA [ 4 , 5 , 6 , 8 , 9 , 10 , 11 , 12 , 14 ] and mean surgical time duration [ 4 , 5 , 7 , 8 , 9 , 11 , 12 , 13 , 14 ], and only five studies were included in the meta-analysis of the incidence rate of intraoperative complications [ 5 , 7 , 9 , 13 , 14 ].…”

“…The 3D HUVS offers better ergonomics (the surgeon does not need to bend the neck to look into the microscope eyepieces) and better visualization (high-resolution surgical field visualization with better magnification). Furthermore, 3D imaging is beneficial for teaching, as everyone in the operating room can see the same high-resolution view that the surgeon observes on the screen [ 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 ]. However, some studies reported different 3D HUVS drawbacks, such as a possible longer surgical time, a challenging learning curve, and a higher surgical workload [ 9 , 11 ].…”

Active-fluidics versus gravity-fluidics system in phacoemulsification for age-related cataract (AGSPC): study protocol for a prospective, randomised, double-blind, controlled clinical trial

“…2 28 Actually, researches on cataract surgery have not ceased in the past decades in the pursuit of better results. [29][30][31] Therefore, studies are in emergent need to verify whether updates in the surgical systems do lead to better outcomes. The Open access active-fluidics system has been put into use for many years, but it is not yet widespread.…”

“…The vision loss caused by cataract is a huge burden on society and families; fortunately, it is curable 2 28. Actually, researches on cataract surgery have not ceased in the past decades in the pursuit of better results 29–31. Therefore, studies are in emergent need to verify whether updates in the surgical systems do lead to better outcomes.…”

Comparison of Three-Dimensional Surgical System Versus Binocular Microscope for Clear Corneal Incision in Cataract Surgery

“…Three previously published articles have described no difference in the total surgical time between the 3D system and BM [ 3 , 17 , 23 ]. However, one study reported that the duration of cataract surgery was 5 min shorter with the use of the 3D surgical system [ 24 ].…”