ESCRS - PP19.10 - Three-Year Post Implantation Multinational Evaluation Of A New Aspheric Hydrophobic Monofocal Intraocular Lens

Three-Year Post Implantation Multinational Evaluation Of A New Aspheric Hydrophobic Monofocal Intraocular Lens

Published 2022 - 40th Congress of the ESCRS

Reference: PP19.10 | Type: Free paper | DOI: 10.82333/s685-tw92

Authors: Miguel Angel Teus* 1 , Uday Bhatt 2 , Mayank A. Nanavaty 3 , Rachael Peterson 4 , Rudy M.M.A. Nuijts 5

1UNIVERSIDAD DE ALCALA,Madrid,Spain, 2Vision Eye Institute,Melbourne,Australia, 3Sussex eye Hospital, NHS trust,Sussex,United Kingdom, 4Alcon Research,Fort Worth, Texas,United States, 5Maastricht University ,Maastricht,Netherlands

Purpose

To report the visual acuity, refractive, and safety outcomes of the Clareon® (Alcon Vision, LLC) aspheric, hydrophobic, monofocal, intraocular lens (IOL) 3 years after implantation.

Setting

Prospective, multinational, single-arm long-term (3-year) safety and effectiveness trial

Methods

This was a prospective, multinational, single-arm trial assessing the long-term (3-year) safety and effectiveness of the Clareon IOL implanted bilaterally in adults (≥ 22 years of age) who required bilateral cataract extraction. Participants attended 12 study visits (9 post-implantation) over approximately 36 months. The primary study objectives were to demonstrate the long-term (3 year) visual acuity and adverse event (AE) outcomes of the Clareon IOL, and the one-year visual acuity and AE outcomes compared to historical safety and performance endpoint (SPE) rates as reported in EN ISO 11979-7:2014. 

Results

245 participants enrolled; 215 were implanted; 183 first and 182 second eyes were analyzed at 3 years. At 1 year, the primary effectiveness and safety endpoints were met and were greater than the SPE rates. At 3 years, mean corrected distance visual acuity (CDVA) was ‑0.032D in first and second eyes, and ≥92.3% of eyes had CDVA 20/25. Mean manifest refractive spherical equivalent was within target (emmetropia) by 1-week and maintained at 0.088D in first and 0.106D in second eyes at 3 years. All eyes had Grade 0 glistenings at 3 years. There were no unanticipated AEs. The rate of clinically significant PCO requiring Nd:YAG was 3.3% in first eyes and 6.2% in second eyes at 3 years. 

Conclusions

The 3-year visual outcomes were excellent and had stable refractive results. There were no unanticipated AEs, all IOLs had Grade 0 glistenings, and rates of PCO and Nd:YAG were very low.