Purpose: 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 receivedfemtosecond 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.
RCT Entities:
Purpose: 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.