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

Abstract

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.

Plain language summary

This research study aimed to investigate the outcomes of the EVO/EVO+ Implantable Collamer Lens (ICL), a potential alternative to laser vision correction procedures for people with refractive errors such as myopia, with and without astigmatism. One of the goals was to study how effective and safe the EVO ICL is by analyzing a large group of patients (225 eyes, 113 patients) who had undergone implantation of these lenses at a single practice in the US.

We examined postoperative vision, complication rates, and percentage of patients that required a secondary procedure for a visual enhancement. One hundred percent of patients whose vision was correctable to 20/20 in either eye preoperatively achieved 20/20 vision or better without correction at one month postoperatively. Among eyes that were correctable to 20/20 preoperatively, 95% achieved 20/20 or better without correction postoperatively and 99% of eyes achieved 20/25 or better.

EVO ICL offers great visual outcomes and is an effective treatment option for the treatment of myopia with and without astigmatism. This procedure has a low risk for complications, indicating its safety. By providing this comprehensive evaluation, we hope to give people considering incorporating the EVO ICL surgery into their practice a better understanding of the safety and effectiveness of the procedure. Ultimately, our study aims to improve patient outcomes and enhance the overall quality of care in the field of refractive surgery.

Keywords:

• refractive surgery
• visual outcomes
• postoperative complications
• myopia
• astigmatism

Acknowledgments

The authors would like to acknowledge the doctors and staff at Parkhurst NuVision including Anthony Vanrachack, OD, Alexandra Wiechmann, OD, Thomas Nettleton, OD, Darcy Seaton, OD, FAAO, Lily Arendt, OD, Amanda Groenhuyzen, OD, Noelle Abraham, OD, and Tyson Gibbons, OD, for the unwavering dedication and exemplary care provided in this clinical practice.

Disclosure

G. Parkhurst is a consultant for Alcon Laboratories, Inc.; Johnson & Johnson Vision; Carl Zeiss Meditec; LensAR; Novartis Pharmaceuticals Corporation; and STAAR Surgical. He has received research support from Alcon Laboratories, Inc.; Johnson and Johnson Vision; LensAR; STAAR Surgical; Glaukos; Novartis; Ocular Therapeutix; Sight Sciences; and Sun Pharmaceutical Industries.

B. Mueller is a consultant for Alcon Laboratories, Inc.; Johnson & Johnson Vision; and STAAR Surgical. He has received research support from Alcon Laboratories, Inc. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was supported by an unrestricted research grant from STAAR Surgical. The views expressed in this article are solely those of the authors.