A Pilot Study: Short-Term Safety Evaluation Of Evo-Icl Implantation Using A Viscoelastic-Free Technique Under Natural Pupil State

To evaluate the short-term safety and clinical outcomes of EVO-ICL implantation using a viscoelastic-free technique under natural pupil conditions.

 Fudan University Eye and ENT Hospital (Shanghai, China)

This prospective, consecutive case series included 42 eyes of 21 patients (9 male, mean age 27.5±5.3 years) undergoing EVO-ICL implantation for myopia between October 2024 and January 2025. Preoperative measurements included mean spherical equivalent (-8.25±2.45D), astigmatism (-0.85±0.65D), anterior chamber depth  (3.16±0.21mm), and endothelial cell density (ECD) (2731±276 cells/mm²). Primary outcome were surgical duration, anterior chamber reaction, intraocular pressure changes, ECD variations at 1, 8, and 24 h postoperatively, and corneal densitometry (Pentacam). Secondary endpoints included patient satisfaction (Quality of Vision questionnaire). Data were analyzed using SPSS 26.0, with p<0.05 considered significant.

At 24 hours postoperatively, the efficacy index (postoperative UDVA/preoperative CDVA) was 1.08±0.20, and the safety index (postoperative CDVA/preoperative CDVA) was 1.22±0.25. Mean total surgical time was significantly reduced to 3.5±0.7 minutes, with anterior chamber manipulation limited to 1.3±0.5 minutes. At the 24-hour follow-up, all eyes maintained normal intraocular pressure, exhibited minimal anterior chamber reaction, showed no significant increase in corneal densitometry compared to preoperative measurements (P>0.05), demonstrated normal pupillary light reflex, and had endothelial cell density loss rates <5%. Patient visual satisfaction scores reached 9.2±0.8 (on a 10-point scale).

 EVO-ICL implantation using a viscoelastic-free technique under natural pupil conditions demonstrates excellent safety and clinical feasibility, characterized by rapid visual recovery and high patient satisfaction.