A Comprehensive Retrospective Analysis of EVO/EVO+ Implantable Collamer Lens: Evaluating Refractive Outcomes in the Largest Single Center Study of ICL Patients in the United States.

PURPOSE: We evaluate visual outcomes in patients with EVO/EVO+™ (posterior chamber phakic intraocular lens with a central port) within approved United States (US) age and refractive range indications.

PATIENTS AND METHODS: This single-center retrospective study evaluated one-month, single-center postoperative data for 225 eyes meeting inclusion criteria and undergoing EVO/EVO+ implantation from April to October 2022. Data included lens size (mm), lens power (diopters of spherical and cylindrical power), preoperative best corrected visual acuity, preoperative spherical equivalent from manifest refraction, achieved postoperative uncorrected visual acuity, postoperative refraction, intraocular pressure (mmHg), and adverse events.

RESULTS: A total of 225 eyes underwent EVO/EVO+ Implantable Collamer Lens (ICL) implantation from April to October 2022, with 51.5% receiving toric lenses. The most common ICL size was 12.6mm (56.4%), followed by 13.2mm (27.5%), 12.1mm (15.1%), and 13.7mm (0.9%). Among patients with preoperative BCVA of 20/20 or better (149 eyes), 95.2% achieved postoperative UCVA of 20/20 or better, and 99.3% achieved UCVA of 20/25 or better at postoperative month one. About 75% of eyes were within a spherical equivalent target of ±0.50 D and 94% within ±1.00 D. Toric ICLs were implanted in 116 eyes (51.8%). Of these, anticipated residual cylinder >1 diopter was seen in 21 eyes (18.1%) resulting in three rotations, three explants, and three laser vision correction (LVC) enhancements. The postoperative adjustment rate (including rotations, exchanges, and LVC enhancement) was minimal (4.8%). Incidence of major adverse events was 0%.

CONCLUSION: Our study, the largest US single-center analysis of EVO/EVO+ ICL implantation, demonstrates strong early results and infrequent adverse events, supporting ICL safety and effectiveness. High predictability and favorable visual outcomes, including 20/20 or better, highlight the reliability of this technology. Despite study limitations, our findings underscore this technology's effectiveness. Future research should refine patient criteria and assess long-term outcomes in this evolving landscape.