At the invite-only Artiplus Experts Panel during ESCRS 2024 in Barcelona, Spain, the unveiling of one-year clinical trial outcomes for the Artiplus (Ophtec; Groningen, Netherlands) iris-fixated multifocal phakic intraocular lens sparked significant interest among the esteemed refractive surgeons in attendance.
The Artiplus lens, designed for phakic patients with presbyopia, leverages the established safety and efficacy of Ophtec’s Artiflex platform, along with patented continuous transitional focus (CTF) technology. This innovative solution aims to address the unique needs of phakic presbyopes, providing a clear alternative to conventional multifocal IOLs that often struggle with glare and halos—common issues for cataract patients. By targeting this specific population, Artiplus offers a tailored approach to vision correction, enhancing the quality of life for those seeking clarity at all distances.
With a refractive design intended to maximize far vision while reducing visual distortions, the Artiplus lens is unique in its segment. Its development has been under rigorous evaluation in a multicenter international clinical trial, involving nine sites across Europe and South Korea. The study followed 42 patients (84 eyes), all of whom received bilateral implantation of the Artiplus IOL. As the trial progresses, the current one-year results offer a glimpse into what the future holds for this novel technology.
The study design
The Artiplus lens trial was open-label, prospective and non-controlled, with a planned follow-up period of three years. Key inclusion criteria for participants included adult presbyopic patients requiring reading glasses of at least +1.0 D, a residual refractive cylinder of less than or equal to 0.75 D postoperatively, and a minimum anterior chamber depth of 2.80mm or 3.00mm based on age. These criteria ensured that the trial focused on patients most likely to benefit from the Artiplus lens.
The primary outcomes measured included corrected and uncorrected visual acuity at near, intermediate and distance, residual spherical equivalent, defocus curve, contrast sensitivity, intraocular pressure and endothelial cell count. Subjective assessments, such as patient satisfaction and quality of vision, were also integral to evaluating the lens’s real-world impact.
Prof. Dr. José Luis Güell (Spain), the lead investigator of the study, presented the interim one-year results to an attentive audience at the event. As one of the leading experts in the field, Prof. Dr. Güell offered insights into the trial’s progress, focusing on visual acuity improvements and patient feedback.
A year in review
The trial’s visual acuity results were notably encouraging. Patients in the trial started with a mean spherical equivalent error of -4.98 D ± 2.27 preoperatively, but after one year, this figure had significantly improved to -0.32 D ± 0.27. Such outcomes demonstrate the Artiplus lens’s effectiveness in delivering clear vision for both near and far distances.
Binocular uncorrected distance visual acuity (UDVA) also saw significant improvement, with mean preoperative scores at 0.85 ± 0.28 LogMAR, which improved to a mean of 0.06 ± 0.07 LogMAR at one year. The results for binocular uncorrected intermediate and near vision were similarly strong, with 0.01 ± 0.10 LogMAR and 0.01 ± 0.07 LogMAR recorded at one year, respectively.
In his presentation, Prof. Dr. Güell emphasized these findings, noting, “The visual acuity results are extraordinary. The outcomes for uncorrected distance, uncorrected intermediate and uncorrected near were certainly very good.”
Additionally, the trial’s defocus curve—a crucial measure of how well patients can focus at varying distances—revealed an unprecedented ability to provide seamless vision across all distances, a feat that sets it apart from any other IOL on the market today. “What’s remarkable is how well these eyes adapt,” Prof. Dr. Güell commented, highlighting how the innovative technology and the patients’ residual accommodation play a pivotal role in this achievement.
This exceptional performance aligns perfectly with the newly published continuous full range of vision categorization by the ESCRS Functional Vision Working Group. The defocus curve not only exemplifies the capabilities of the Artiplus but also meets the evidence-based classification that defines multifocal IOLs improving visual acuity from intermediate to near vision below 0.05 LogMAR.1
Satisfaction and safety
Beyond visual acuity, the trial also examined patient satisfaction, with results revealing high levels of contentment with the procedure. Approximately 98% of participants reported being either “quite” or “very” satisfied with their uncorrected vision. Specifically, 100% of patients were satisfied with their distance and intermediate vision, while 90% expressed satisfaction with their near vision.
Feedback from participants underscored the lens’s ability to deliver on its promises. In particular, 92% of patients reported never or only occasionally noticing glare, while 93% said they experienced minimal halos. These figures suggest that the Artiplus lens is achieving its goal of minimizing the visual disturbances often associated with multifocal lenses.
The occurrence of adverse events was minimal, with most issues resolving without long-term impact. A few cases of dry eye (2), increased intraocular pressure (2), and mild inflammatory deposits on the IOL (3) were noted, but these were asymptomatic or resolved without complications. One case of optic neuritis was recorded, though it was classified as unrelated to the device and later resolved. Overall, these findings indicated a strong safety profile for the Artiplus lens, with minimal complications observed during the first year.
Endothelial cell count (ECC) loss is a crucial metric for evaluating the long-term safety of IOLs, and the data for Artiplus, which was built on the trusted Artiflex platform, reflects this commitment to safety with a mean ECC loss of just -0.30% at six months. Prof. Dr. Güell emphasized that numerous studies support the long-term safety of the Artiflex platform, showing that when guidelines are adhered to, concerns about endothelial cell loss are minimal. Moreover, comparisons with both posterior and iris-fixated phakic IOL studies reveal similar ECC loss profiles, reinforcing the reliability of Artiplus in preserving endothelial health.2,3,4,5
The road ahead
As the Artiplus trial moves into its second year, the ophthalmology community remains keen to see how these outcomes will evolve over time. With the interim results already demonstrating a high degree of success in terms of visual acuity, patient satisfaction and safety, there is considerable optimism surrounding the lens’s potential for wider adoption.
The Artiplus lens, with its innovative approach to presbyopia correction in phakic patients, offers a glimpse into the future of eye care—one that prioritizes both functional vision and patient experience. It has the potential to reshape the landscape of presbyopia correction by providing a superior alternative to clear lens extraction (CLE), which carries risks such as retinal detachment and early cataract formation. As more data emerges, this lens could redefine the standards for presbyopia treatment, offering a stable and effective solution for those looking to enhance their visual quality without compromising their long-term eye health.
In terms of regulatory progress, Artiplus has already secured approval in Argentina and South Korea, where the first commercial units have been sold. Ophtec is now awaiting the CE green light from a European notified body. With CE approval on the horizon, patients and surgeons alike anticipate the availability of Artiplus across European markets.
Editor’s Note: Reporting for this story took place during the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from 6-10 September in Barcelona, Spain. A version of this article was first published in CAKE magazine Issue 24.
References
- Ribeiro F, Dick BH, Kohnen T, et al. Evidence-based functional classification of simultaneous vision intraocular lenses: Seeking a global consensus by the ESCRS Functional Vision Working Group. Journal of Cataract & Refractive Surgery. 2024;50(8):794-798.
- Jonker SMR, Berendschot TTJM, Ronden AE, et al. Five-year endothelial cell loss after implantation with Artiflex myopia and Artiflex toric phakic intraocular lenses. Am J Ophthalmol. 2018 Oct;194:110-119.
- Monteiro T, Correia FF, Franqueira N, et al. Long-term efficacy and safety results after iris-fixated foldable phakic intraocular lens for myopia and astigmatism: 6-year follow-up. J Cataract Refract Surg. 2021 Feb 1;47(2):211-220.
- Papa-Vettorazzi MR, Moura-Coelho N, Manero F, et al. Long-term efficacy and safety profiles of iris-fixated foldable anterior chamber phakic intraocular lens implantation in eyes with more than 10 years of follow-up. J Cataract Refract Surg. 2022 Sep 1;48(9):987-992.
- Papa-Vettorazzi MR, Güell JL, Cruz-Rodriguez JB, et al. Long-term efficacy and safety profiles after posterior chamber phakic intraocular lens implantation in eyes with more than 10 years of follow-up. J Cataract Refract Surg. 2022 Jul 1;48(7):813-818.
