Artiflex foldable lens for myopia correction results of 10 years of follow-up

Abstract

The aim of this study was to evaluate the long-term efficacy and safety of the Artiflex® lens implant and to follow the evolution of the number of corneal endothelial cells over time. Design It was a retrospective study of an observational case series of patients who underwent surgery at "The INVISION Ophthalmic Hospital" (Almería, Spain) in 2007 and who were followed for 10 years. Methods Setting: Clinical practice. Study population included 53 eyes of 30 patients who underwent an Artiflex® lens implant for the correction of myopia from −4 to −14 D. Each patient included in this study had stable myopia for at least 2 years and a contraindication for corneal refractive surgery. The efficacy index was defined as the quotient between uncorrected distance visual acuity postoperative and best-corrected distance visual acuity (BCDVA) preoperative. The safety index was calculated as the quotient between BCDVA postop and BCDVA preop. Results The average efficacy and safety indices of the lenses implanted were 1.1 (SD 0.30) and 1.06 (SD 0.2) at 10 years of follow-up. In this period of time there has been a loss of 12% of the corneal endothelial cells. The postoperative complications were pigment dispersion in four eyes (7%) of four patients and decentration of phakic intraocular lens in two eyes (4%) of another two patients. Conclusions The Artiflex® foldable phakic lens could be a safe and effective long-term alternative for myopic patients in whom laser surgery was contraindicated.

Eight-year follow-up of Artiflex and Artiflex Toric phakic intraocular lens

“…Mean CDVA significantly improved from preoperative to postoperative visits for both pIOLs and remained stable during the follow-up. CDVA was 0.06 ± 0.09 log-MAR at 8 years of follow-up for Artiflex Myopia, which is in accordance with the 0.04 ± 0.02 of Monteiro et al 9 after 6 years and the 0.92 decimal (approximately 0.036 logMAR) of Castro de Luna et al 7 after 10 years. In Castro de Luna et al's 7 study, CDVA reached a maximum after 2 years and stabilized until 10 years.…”

“…CDVA was 0.06 ± 0.09 log-MAR at 8 years of follow-up for Artiflex Myopia, which is in accordance with the 0.04 ± 0.02 of Monteiro et al 9 after 6 years and the 0.92 decimal (approximately 0.036 logMAR) of Castro de Luna et al 7 after 10 years. In Castro de Luna et al's 7 study, CDVA reached a maximum after 2 years and stabilized until 10 years. Mean CDVA for Artiflex Toric was also in agreement with several studies after 6 months, 15 1 year 17,18 and 2 years with Artisan Toric (the rigid version of Artiflex).…”

“…6 Artiflex lens (Ophtec B.V., Groningen, The Netherlands) is an iris-fixated foldable pIOL that has demonstrated to be effective, safe and highly predictable for the correction of myopia and astigmatism. [7][8][9] However, as an anterior chamber IOL, potential endothelial damage due to surgical implantation and proximity to the endothelial layer makes it important to evaluate long-term endothelial cell loss. [10][11][12] The toric version of Artiflex offers the advantage of correcting myopic refractions with astigmatism, and its iris-claw fixation provides excellent stability.…”

“…Several studies 7,9,[14][15][16][17][18][19] have evaluated safety, efficacy, predictability, stability and endothelial cell loss of the spheric and/or the toric version as a group. However, there is still a lack of long-term visual data for both lenses separately.…”

Two-year results after combined phacoemulsification and iris-fixated phakic intraocular lens removal

“…The implantation of a phakic intraocular lens (pIOL) allows treatment of (high) refractive errors, with the advantage of sparing the crystalline lens. One of the most common anterior chamber pIOLs is the iris-fixated (IF) Artisan pIOL [1] and has been demonstrated to be an effective, predictable, and stable procedure for all models [1][2][3]. However, regular lifetime follow-up is needed, as increased endothelial cell density (ECD) loss remains a concern after any type of…”