Long term efficacy and safety profiles of iris-fixated foldable anterior chamber phakic intraocular lens implantation in eyes with ≥ 10-year follow-up

Papa-Vettorazzi, Renato; Moura-Coelho, Nuno; Manero, Felicidad; Cruz-Rodriguez, José B; Elíes, Daniel; Güell, José L.

doi:10.1097/j.jcrs.0000000000000937

Cited by 6 publications

(25 citation statements)

References 17 publications

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“…Finally, corneal endothelial cell changes were also evaluated, with an ECD loss of 2.01% at 4 weeks after surgery that increased to 9.11% at the end of the follow-up (13 years). This ECD loss is consistent with those reported in other long-term series evaluating the performance of the same pIOL [1,2]. Papa-Vetorazzi et al [2] found in a sample of eyes implanted with the Arti ex pIOL and followed for more than 10 years a mean ECD loss of 12.2 ± 12.5%.…”

Section: Discussionsupporting

confidence: 88%

“…Concerning IOP, there was a non-signi cant trend to its increase in the initial postoperative period (4 weeks postoperatively), and a signi cant reduction afterwards from the 4-week to 1-year postoperative visit. Similarly, no signi cant increases in IOP have been also reported in other long-term series evaluating the outcomes of the Arti ex pIOL [1,2]. This is consistent with the maintenance of a wide anterior chamber after surgery and a minimal reduction of ACD.…”

Section: Discussionsupporting

confidence: 84%

“…These studies are critical to de ne the safety of these intraocular implants as some pIOL models have been associated to some complications in the long term that should have been considered prior to their recommendation [18]. Speci cally, concerning the foldable iris-xated pIOL evaluated in the current study, some previous studies have been conducted con rming that the integrity of corneal endothelium is preserved and that complications are minimal [1][2][3]8]. The aim of the current study was to analyse retrospectively the clinical outcomes obtained during a 13-year follow-up period with the Arti ex pIOL in our centre, evaluating the e cacy and stability of the refractive correction achieved as well as the safety pro le of the pIOL (endothelial cell changes, potential shortening of the anterior chamber, IOP changes and complications).…”

Section: Discussionmentioning

confidence: 91%

“…Iris-xated phakic intraocular lenses (pIOLs) have been available for over 25 years, with extensive research reporting the safety and e cacy of these implants for the correction of myopia [1][2][3][4][5][6]. Initially, this type of pIOL was made of rigid material which supposed the need for a large corneal incision for its implantation, with the potential of induction of some unpredictable astigmatic changes with such incision [7].…”

Section: Introductionmentioning

confidence: 99%

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Long-term safety and efficacy of a foldable iris-fixated phakic intraocular lens for the correction of myopia

Royo

Jiménez

Piñero

2023

Preprint

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Purpose: To analyze and report the 13-year follow-up outcomes in terms of efficacy and safety of eyes implanted with the spherical version of a foldable iris-fixated phakic intraocular lens (pIOL) for the correction of myopia. Methods: A retrospective analysis of the results of 56 eyes of 32 patients (age, 19-45 years) who underwent implantation of the spherical model of the Artiflex pIOL (Ophtec B.V., Groningen, The Netherlands) for the correction of myopia. Visual, refractive, biometric, intraocular pressure (IOP) and corneal endothelial changes were evaluated during a 13-year follow-up. Results: At 4 weeks postoperatively, a significant reduction of manifest sphere and spherical equivalent (SE), with a significant improvement of uncorrected distance visual acuity (UDVA) associated (all p<0.001) were found. No significant changes were found during the rest of follow-up in sphere (p≥0.072). The percentage of eyes with SE within ±1.00 D was over 83% during the whole follow-up. A non-significant trend to IOP increase was observed at 4 weeks postoperatively (p=0.530), with a significant reduction at 1 year after (p=0.039) and no significant changes during the rest of follow-up (p=0.180). There was an initial significant reduction of anterior chamber depth (p<0.001), with no significant changes during the following 9 years of follow-up (p=0.118). Mean endothelial cell loss changed from 2.01% at 4 weeks after surgery to 9.11% at the end of the follow-up. No complications were reported during the follow-up. Conclusions: Myopia correction with the Artiflex pIOL is an effective and safe procedure in the long term.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 91%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Long-term safety and efficacy of a foldable iris-fixated phakic intraocular lens for the correction of myopia

Royo

Jiménez

Piñero

2023

Preprint

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“…In our series, the percentage of eyes that lost more than 1.6% of EC density yearly (upper limit of normality obtained from the study by Bourne et al) was 19.7% (15/76). 1 However, of those 15 eyes, 11 had an endothelial cell count (ECC) of more than 2000 cells/mm 2 and none have lost more than 25% of their EC density at the final follow-up. Four eyes of 3 patients (5.2%) had less than 2000 cells/mm 2 and have lost more than 25% of their ECC at the final followup, and this is similar to the 5-year results reported by Jonker et al in their Artiflex study (4.3% -4.4%).…”

mentioning

confidence: 99%

Comment on: 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

Tello

Galvis²,

Berrospi³

et al. 2022

J Cataract Refract Surg

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years) was 12.2% ± 12.5%. The postoperative ECL not related to surgical trauma (calculated from 12 months after the procedure to the last follow-up visit) was 8.8% ± 11.9%, and the authors indicated that the calculated mean rate was 1.0% cell loss per year.We consider it important to clarify some additional details about ECL. What percentage of eyes lost more than 1.6% of endothelial density yearly (upper limit of normality obtained from the mean plus 2 standard deviations of the classic study by Bourne et al.)? In the box and whisker plot shown in the supplementary material, it can be seen that a number of eyes reached final endothelial densities of less than 2000 cells/ mm 2 and, in fact, some densities dropped to a value close to 1600 cells/mm 2 , which is in proximity to the explantation criterion defined by the French Agency for the Safety of Medical Devices (1500 cells/mm 2 ). It would be very interesting to know what percentage of eyes were below 2000 cells/mm 2 , the age of these patients, and the postoperative follow-up time. It would also be important to know if any of the eyes lost ≥25% of preoperative endothelial density, which is the limit recommended by the American Academy of Ophthalmology to consider explanting a pIOL.Several studies have recently been published showing significant long-term ECL with iris-claw pIOLs (Artisan and Artiflex). In 67 eyes with the Artisan iris-claw pIOL for myopic errors with a mean follow-up of 9.6 ± 3.0 years, we found that 29.9% of them lost ≥25% of preoperative endothelial cell density at the last follow-up visit, that 60.8% lost a percentage of endothelial cells greater than the expected physiological loss (>1.6% per year), and that 7.5% had an endothelial density of less than 1500 cells/mm 2 . 2 Indeed, in a newer publication, we reported that we had to explant 5 Artisan pIOLs (6.3% of the group) because of late ECL (mean follow-up time 11.9 ± 3.5 years). 3 In 2018, Jonker et al., with Artiflex and Artiflex toric pIOLs, reported a total chronic ECL from 6 months to 5 years postoperatively of 10.5% in the spherical group and 10.2% in the toric group. After 5 years, 4.4% and 4.3% of eyes, respectively, had ≥25% loss of endothelial cells and 3.0% of eyes in the Artiflex pIOL group had a cell density of less than 1500 cells/mm. 2,4 The issue of chronic corneal endothelial loss, knowing that in humans, these cells have almost completely inhibited the in vivo mitosis, is critical, especially in these patients who are implanted with these pIOLs at an early age and have many decades of life ahead of them. 5

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Long-term safety and efficacy of a foldable iris-fixated phakic intraocular lens for the correction of myopia

Royo,

Jiménez,

Piñero

2023

Int Ophthalmol

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Purpose To analyze and report the long-term outcomes in terms of efficacy and safety of eyes implanted with the spherical version of a foldable iris-fixated phakic intraocular lens (pIOL) for the correction of myopia. Methods Retrospective analysis of the results of 56 eyes of 32 patients (age, 19–45 years) who underwent implantation of the spherical model of the Artiflex pIOL (Ophtec B.V., Groningen, The Netherlands) for the correction of myopia. Visual, refractive, biometric, intraocular pressure (IOP) and corneal endothelial changes were evaluated during a long-term follow-up: 2, 7, 10 and 12 years for more than 50, 30, 20 and 10 eyes, respectively. Results At 4 weeks postoperatively, a significant reduction of manifest sphere and spherical equivalent (SE), with a significant improvement of uncorrected distance visual acuity were found (all p < 0.001). No significant changes were found during the rest of follow-up in sphere (p ≥ 0.072). The percentage of eyes with SE within ± 1.00 D was over 83% during the whole follow-up. A non-significant trend to IOP increase was observed at 4 weeks postoperatively (p = 0.530), with a significant reduction at 1 year after (p = 0.039) and no significant changes during the rest of follow-up (p = 0.180). There was a significant reduction of anterior chamber depth at 4 weeks after surgery (p < 0.001), with no significant changes during the following 9 years of follow-up (p = 0.118). However, an additional significant decrease of this parameter was observed between 10 and 13 years after surgery (p = 0.027). Mean endothelial cell loss changed from 2.01 ± 4.49% at 4 weeks after surgery to 9.11 ± 2.24% at the end of the follow-up. No complications were reported during the follow-up. Conclusions Myopia correction with the Artiflex pIOL is an effective and safe procedure in the long term.

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Long term efficacy and safety profiles of iris-fixated foldable anterior chamber phakic intraocular lens implantation in eyes with ≥ 10-year follow-up

Abstract: To evaluate the long-term efficacy, safety, predictability, and stability of a foldable anterior chamber phakic intraocular lens (pIOL) (Artiflex) implantation in eyes with more than 10 years of follow-up.

Cited by 6 publications

References 17 publications

Long-term safety and efficacy of a foldable iris-fixated phakic intraocular lens for the correction of myopia

Long-term safety and efficacy of a foldable iris-fixated phakic intraocular lens for the correction of myopia

Comment on: 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

Long-term safety and efficacy of a foldable iris-fixated phakic intraocular lens for the correction of myopia

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