Abstract
INTRODUCTION: To compare surgical outcomes of 2.2 mm clear corneal incision (CCI) between a three-dimensional (3D) visualization system and traditional binocular microscope (BM) for phacoemulsification and intraocular lens implantation surgery. METHODS: In this randomized controlled clinical study, 60 eyes with age-related cataracts were divided into two groups receiving cataract surgery using either a 3D vision system (n = 30 eyes) (3D group) or a binocular microscope (n = 30 eyes) (BM group). We recorded and statistically analyzed surgical parameters and pre- and postoperative ocular parameters. Primary outcomes included the change in endothelial cell density (ECD) and CCI architecture, and secondary outcomes comprised other ocular parameters and surgical parameters. All procedures complied with the tenets of the Declaration of Helsinki. RESULTS: Of the 60 eyes randomly assigned between January 5, 2021, and May 9, 2021, 55 (26 eyes in the 3D group and 29 eyes in the BM group) were analyzed. The ECD loss rate was 8.1% in the 3D group and 12.3% in the BM group, but the difference was not statistically significant. Local detachment of Descemet's membrane was seen in 50% (13 eyes, 3D group) and 51.6% (15 eyes, BM group), wound gaping at the endothelial side in 15.4% (four eyes, 3D group) and 10.3% (four eyes, BM group), gaping at the epithelial side in 11.5% (three eyes, 3D group) and 6.9% (two eyes, BM group), and misalignment of the incision in 3.4% (one eye, BM group) 1 day after surgery. These abnormalities improved with time. There was no difference between the 3D group and BM group in terms of other ocular parameters or surgical parameters before and after surgery. CONCLUSIONS: Using the 3D surgical system for phacoemulsification and IOL implantation surgery seems to result in similar ECD and CCI conditions as using a conventional binocular microscope. TRIAL REGISTRATION: The protocol was registered on ClinicalTrials.gov (NCT04839250).