Comparison of three-dimensional surgical system versus binocular microscope for implantable Collamer lens implantation: a randomized clinical trial

To compare the efficacy, safety, visual outcomes, satisfaction, and comfort of three-dimensional (3D) heads-up visualization system-assisted and conventional microscopic implantable Collamer lens (ICL) surgery.

Patients undergoing ICL or Toric ICL (TICL) implantation were enrolled and randomized into two groups: TM group (under a conventional microscope) and 3DM group (under NGENUITY 3D visualization system). Ocular parameters were assessed preoperatively and at 1wk, 1, 3, and 6mo postoperatively. The duration of key surgical steps and the incidence of complications were recorded. Patient-reported outcomes (dry eye, visual quality, comfort) and surgeon satisfaction were assessed using standardized questionnaires.

The study included 98 eyes of 98 refractive error patients (17 males), 50 eyes in TM group (age 27.74±5.65y), and 48 eyes in 3DM group (age 29.20±4.89y). Efficacy, safety, quality of vision (QoV), dry eye symptoms, and patients’ satisfaction at 6mo were not significant across the time points of 1wk, 1, 3 and 6mo. No complication was observed in either group. The 3DM group was associated with a longer main step operation time (P=0.037) but better patient visual comfort (P<0.001). The difference in surgical fluency was not statistically significant (P=0.067). Notably, surgeons reported no delays or discomfort and rated the 3DM system significantly higher in image resolution, range of view, depth perception, color contrast, and postural comfort (all P<0.001).

For ICL surgery, the use of the NGENUITY 3D visualization system achieves comparable surgical efficacy, safety, and patient satisfaction to procedures performed under a traditional microscope, while delivering superior intraoperative visual performance and postural comfort for the surgeon. These ergonomic and visual advantages make it a promising tool for enhancing clinical practice and surgical training.