Clinical Study On Customized Orientational Implantation Of Evo Icl For Myopia

To evaluate the safety, efficacy, vault, and rotational stability of customized orientational implantation of EVO ICL for myopia.

Eye and ENT Hospital of Fudan University, China.

Cohort study. The study included 86 eyes of 86 patients (16 males, mean age, 27.0 ± 5.0 years and mean SE, -7.85±2.06 D) who underwent customized orientational implantation of EVO ICL and 56 eyes of 56 patients (9 males, mean age, 27.0 ± 4.5 years and mean SE, -8.39±1.87 D) who underwent horizontal implantation. In the group of customized orientation, the ICL was chosen in a specific size and orientation (horizontal or vertical) based on white-to-white, anterior chamber depth, as well as horizontal and vertical sulcus-to-sulcus. Refractive and ICL vault statuses were observed 6 months after surgery. Rotational stability was assessed in TICL eyes implanted in customized orientation using digital anterior segment photographs. 

At 6 months, the safety index was 1.35 ± 0.15 in the group of customized orientation (GC) and 1.22 ± 0.16 in the group of horizontal orientation (GH) (P<0.001). Neither lens opacity nor a significant change in endothelial cell density was found. The efficacy index was 1.23 ± 0.19 in GC and 1.17 ± 0.18 in GH (P=0.09). All eyes achieved an uncorrected distance visual acuity of 0.10 logMAR or better. Ideal vault (250–750μm) was achieved in 88% of eyes in GC and 80% in GH (P=0.33); 1% of eyes in GC and 11% in GH had a vault over 750μm (P=0.03). Spherical equivalent in 95% of eyes in GC and 91% in GH was within ±0.5D. No significant difference in axis misalignment was observed between vertically and horizontally implanted TICL in GC (P=0.89).

Customized orientational implantation of EVO ICL provided good efficacy, safety, predictability, and rotational stability in correcting myopia and reduced the incidence of excessive vault.