Foldable Phakic Intraocular Lens Research Articles

Long-term results in patients with iris-fixated foldable phakic intraocular lenses for myopia and astigmatism.

To evaluate the long-term results of iris-fixated foldable phakic intraocular lens (pIOL) implantation for the management of myopia and astigmatism. Centro Hospitalar Universitário do Porto, Oporto, Portugal. Prospective clinical study. Patients who underwent Artiflex Myopia or Artiflex Toric iris-fixed pIOL implantation for the treatment of myopia or astigmatism between 2003 and 2011 were included. Refractive stability, refractive predictability, safety, efficacy, and cumulative probability of success were evaluated at 5 years, 10 years, and 15 years of follow-up. 5-year, 10-year, and 15-year follow-ups were completed by 199 of 217 (91.7%), 187 of 217 (86.2%), and 43 of 45 (95.6%) eyes implanted with pIOLs, respectively. The mean spherical equivalent was -8.36 ± 2.75 diopters (D), -0.11 ± 0.31 D, -0.33 ± 0.62 D, and -0.80 ± 1.32 D preoperatively and after 5 years, 10 years, and 15 years after surgery. At 5 years, 10 years, and 15 years after surgery, 100%, 95.6%, and 81.6% were within ±1.00 D. The safety and efficacy indexes were 1.07 and 1.06 at 5 years, 1.04 and 0.99 at 10 years, and 1.05 and 1.00 at 15 years of follow-up, respectively. Kaplan-Meier analysis showed survival rates of 97% at 5 years, 73% at 10 years, and 43% at 15 years of follow-up. Long-term results demonstrated that the implantation of Artiflex pIOLs was a stable, predictable, and effective procedure at 5 years, 10 years, and 15 years of follow-up. Annual follow-up visits to evaluate endothelial cell density and anterior chamber depth decrease, to alert patients to this need in the preoperative evaluation, is recommended.

Efficacy and Safety After Toric Posterior Chamber Implantable Collamer Lens and Toric Iris-Fixated Foldable Phakic Intraocular Lens for Myopic Astigmatism.

To compare visual, refractive, and safety outcomes of toric posterior chamber Implantable Collamer Lens (T-ICL) (STAAR Surgical) and toric iris-fixated foldable phakic intraocular lens (IOL) (T-Artiflex; Ophtec BV) implantation for the correction of myopic astigmatism. This retrospective cohort study included 312 eyes of 312 patients who had phakic IOL implantation for myopic astigmatism. Two groups were defined: 205 eyes that underwent T-ICL implantation and 107 eyes that underwent T-Artiflex implantation. Safety, efficacy, and predictability outcomes were evaluated preoperatively and at 12 months postoperatively. Refractive and corneal astigmatic vector analysis were performed using the Alpins method. One year postoperatively, uncorrected distance visual acuity was 0.05 ± 0.18 (T-ICL) and 0.10 ± 0.16 (T-Artiflex) logMAR, with efficacy indexes of 1.16 ± 0.27 and 1.05 ± 0.31, respectively (P < .001). Safety indexes were 1.28 ± 0.30 and 1.21 ± 0.31, respectively (P = .04). Spherical equivalent was within ±0.50 diopters (D) of emmetropia in 165 (80.5%) and 88 (82.2%) eyes, respectively. Refractive astigmatic analysis showed an index of success of 0.28 ± 0.33 (T-ICL) and 0.31 ± 0.26 (T-Artiflex) (P = .07). Surgically induced corneal astigmatism was 0.48 ± 0.74 and 0.81 ± 0.61 D, respectively (P < .001). Mean endothelial loss was 1.11% and 2.05%, respectively (P = .42). Six (2.9%) eyes in the T-ICL group and 1 (0.9%) eye in the T-Artiflex group had phakic IOL repositioning due to significant misalignment. No vision-threatening complications occurred. Both the T-ICL and T-Artiflex groups showed high visual and refractive efficacy with a good safety profile for the correction of myopic astigmatism. T-ICL implantation demonstrated significantly better efficacy and safety indexes after 12 months. Vector analysis showed similar refractive astigmatic correction in both groups, but T-Artiflex implantation revealed higher surgically induced corneal astigmatism. [J Refract Surg. 2022;38(6):339-347.].

Long-term efficacy and safety results after iris-fixated foldable phakic intraocular lens for myopia and astigmatism: 6-year follow-up.

To evaluate the long-term efficacy and safety of iris-fixated foldable phakic intraocular lenses (pIOLs) for the management of myopia and astigmatism after 6-year follow-up. Ophthalmology Department, Hospital Braga, Portugal. Retrospective cohort study. Patients included underwent iris-fixated foldable Artiflex pIOL implantation between January 2010 and December 2013. Follow-up evaluations were performed 6 months postoperatively and every 12 months until 72 months. Preoperative and follow-up data on uncorrected and corrected distance visual acuity (CDVA), manifest refraction, endothelial cell density (ECD), and anterior chamber depth (ACD) were analyzed. A total of 177 eyes of 98 patients with a mean age of 32.33 ± 7.13 years were analyzed. There was a statistically significant improvement in CDVA from 0.09 ± 0.02 logMAR preoperatively to 0.04 ± 0.02 logMAR (P < .0001) at 6 years postoperatively. The spherical equivalent demonstrated a statistically significant improvement from -9.50 ± 2.93 diopters (D) to -0.41 ± 0.45 D at 6 years. At 72 months, the efficacy and safety indexes were 0.94 and 1.15, respectively. A mean loss of 31.77 cells/mm2 (1.19%) was observed each year until the sixth year. The overall mean ECD loss after correction for the physiological loss was 3.02% after 6 years. No correlations were observed between the mean ECD loss and the preoperative ACD. The Artiflex pIOL was a safe, effective, and a stable option to correct myopia. A mean ECD loss of 3.02% was observed over 6 years. No pIOL was explanted due to corneal decompensation.

An angle-supported foldable phakic intraocular lens for correction of myopia: A five-year follow-up

Abstract Objective To evaluate the efficacy and safety of an angle-supported foldable phakic intraocular lens (pIOL) for the correction of moderate to high myopia after 5 years follow-up. Methods Prospective and retrospective, observational, longitudinal, non-randomised consecutive series of cases conducted on a total of 100 eyes of 67 patients with moderate to high myopia implanted with an Acrysof Cachet pIOL (Alcon Laboratories Inc.) with the aim of minimizing the refractive error. The ages ranged between 18 and 60 years. Uncorrected distance visual acuity (UDVA), manifest refraction, corrected distance visual acuity (CDVA), endothelial cells density, pIOL position, intraocular pressure, and complications were recorded preoperatively and during the 5 year follow-up. Results Five years after implantation, the mean manifest spherical equivalent refraction reduced significantly from −11.62 ± 3.35 dioptres (D) to −0.33 ± 0.85 D. UDVA was 20/20 or better in 5 of 25 cases (20%), and 20/40 or better in 22 cases (88%). CDVA was 20/20 or better in 17 cases (68%), and 20/32 or better in 23 cases (92%) of eyes. The residual refractive error was within ±0.50 D of emmetropia in 12 cases (48%), and within ±1.00 D in 19 cases (76%). Mean endothelial cell loss at 5 years was 11.8% central, and 13.7% peripheral. Mean endothelium-pIOL distance was 2.11 ± 0.18 mm, and mean pIOL-crystalline distance was 0.88 ± 0.20 mm. Conclusions This angle supported pIOL provided a favorable refractive correction and predictability, as well as acceptable safety in patients with moderate to high myopia. Although endothelial cell density decreased over 5 years, the results are within the range reported in previous studies with other pIOLs.

Anterior Chamber Foldable Phakic Intra Ocular Lens Safety and Efficacy

Purpose: Correction of myopia by implantation of intra ocular lens is a growing surgery. In this study I am trying to assess the visual outcome stability and safety of eyes undergoing Anterior chamber foldable phakic lens implantation (Artiflex) (Ophtec BV, Groningen, The Netherlands) or (veriflex) (AMO,Santa Ana,CA) for myopia unsuitable for LASIK and detection of early and late complications along three years follow up period. Methods: A retrospective analysis of 25 eyes of 16 patients underwent Anterior chamber foldable phakic IOL (Artiflex) or (Veriflex) implantation for correction of myopia all patients were unsuitable for LASIK all patients underwent surgery with one surgeon in same circumstances. Uncorrected visual acuity, corrected visual acuity (BCVA), higher-order aberrations, patient satisfaction, central endothelial cell count, and PIOL position centration and incarcerated iris tissue were determined along follow up period. Results: At the end of the 36 months of follow up period 14 of the 25 eyes (56 %) achieved BCVA better than that measured pre-operatively and 10 of the 25 eyes (40%) matched their pre-operative BCVA. One eye (4 %) attained a final BCVA worse than pre-operatively, due to recurrent uveitis. One patient (4%) need another surgery to fixate the lens due to slippage of incarcerated iris tissue with impending displacement. Conclusions: This study suggests that Anterior chamber foldable phakic IOL (iris claw lens insertion) Artiflex or Veriflex is beneficial in myopia, unsuitable for LASIK, matching or exceeding preoperative BCVA in the overwhelming majority of the cases. With no major complications however long standing follow up is needed to avoid major complications.

Lente intraocular fáquica plegable acrílica de apoyo angular para la corrección de miopía: seguimiento de 5 años

ObjectiveTo evaluate the efficacy and safety of an angle-supported foldable phakic intraocular lens (pIOL) for the correction of moderate to high myopia after 5 years follow-up. MethodsProspective and retrospective, observational, longitudinal, non-randomised consecutive series of cases conducted on a total of 100 eyes of 67 patients with moderate to high myopia implanted with an Acrysof Cachet pIOL (Alcon Laboratories Inc.) with the aim of minimising the refractive error. The ages ranged between 18 to 60years. Uncorrected distance visual acuity (UDVA), manifest refraction, corrected distance visual acuity (CDVA), endothelial cells density, pIOL position, intraocular pressure, and complications were recorded preoperatively and during the 5 year follow-up. ResultsFive years after implantation, the mean manifest spherical equivalent refraction reduced significantly from −11.62±3.35 dioptres (D) to −0.33±0.85D. UDVA was 20/20 or better in 5 of 25 cases (20%), and 20/40 or better in 22 cases (88%). CDVA was 20/20 or better in 17 cases (68%), and 20/32 or better in 23 cases (92%) of eyes. The residual refractive error was within ±0.50D of emmetropia in 12 cases (48%), and within ±1.00D in 19 cases (76%). Mean endothelial cell loss at 5 years was 11.8% central, and 13.7% peripheral. Mean endothelium-pIOL distance was 2.11±0.18mm, and mean pIOL-crystalline distance was 0.88±0.20mm. ConclusionsThis angle supported pIOL provided a favourable refractive correction and predictability, as well as acceptable safety in patients with moderate to high myopia. Although endothelial cell density decreased over 5years, the results are within the range reported in previous studies with other pIOLs.

Anterior Chamber Foldable Phakic Intra Ocular Lens Safety and Efficacy

Purpose: Correction of myopia by implantation of intra ocular lens is a growing surgery. In this study I am trying to assess the visual outcome stability and safety of eyes undergoing Anterior chamber foldable phakic lens implantation (Artiflex) (Ophtec BV, Groningen, The Netherlands) or (veriflex) (AMO,Santa Ana,CA) for myopia unsuitable for LASIK and detection of early and late complications along three years follow up period. Methods: A retrospective analysis of 25 eyes of 16 patients underwent Anterior chamber foldable phakic IOL (Artiflex) or (Veriflex) implantation for correction of myopia all patients were unsuitable for LASIK all patients underwent surgery with one surgeon in same circumstances. Uncorrected visual acuity, corrected visual acuity (BCVA), higher-order aberrations, patient satisfaction, central endothelial cell count, and PIOL position centration and incarcerated iris tissue were determined along follow up period. Results: At the end of the 36 months of follow up period 14 of the 25 eyes (56 %) achieved BCVA better than that measured pre-operatively and 10 of the 25 eyes (40%) matched their pre-operative BCVA. One eye (4 %) attained a final BCVA worse than pre-operatively, due to recurrent uveitis. One patient (4%) need another surgery to fixate the lens due to slippage of incarcerated iris tissue with impending displacement. Conclusions: This study suggests that Anterior chamber foldable phakic IOL (iris claw lens insertion) Artiflex or Veriflex is beneficial in myopia, unsuitable for LASIK, matching or exceeding preoperative BCVA in the overwhelming majority of the cases. With no major complications however long standing follow up is needed to avoid major complications.

Higher-order aberrations after iris-fixated foldable phakic intraocular lens implantation and wavefront-guided photorefractive keratectomy for the correction of myopia

To compare higher-order aberrations (HOAs) after foldable phakic intraocular lens (pIOL) implantation and wavefront-guided photorefractive keratectomy (PRK) for the correction of myopia. Department of Ophthalmology, Medisch Centrum Haaglanden, Den Haag, The Netherlands. Comparative case series. This retrospective comparative case series comprised eyes that had implantation of an Artiflex foldable pIOL or wavefront-guided PRK. Preoperative and postoperative refractive data, pupil diameter, endothelial cell density, and higher-order aberrations (HOAs) were measured and compared. The median follow-up was 13 months in the pIOL group and 10 months in the PRK group. The mean spherical equivalent (SE) in the pIOL group was -5.50 diopters (D) ± 1.05 (SD) (range -3.25 to -7.13 D) preoperatively and -0.26 ± 0.28 D (range -0.88 to 0.38 D) postoperatively and the mean in the PRK group, -5.72 ± 0.88 D (range -4.25 to -7.50 D) and -0.03 ± 0.42 D (range -0.75 to 1.00 D), respectively. The postoperative SE was within ±0.50 D in 86.4% of eyes and 85.2% of eyes, respectively. Postoperatively, the significant changes in the pIOL group and the PRK group, respectively, were as follows: total HOAs, 0.03 μm and 0.26 μm (P = .001); trefoil-y, 0.09 μm and -0.04 μm (P = .004); spherical aberration, -0.05 μm and 0.21 μm (P = .002). Foldable pIOL implantation increased total HOAs and spherical aberration less than wavefront-guided PRK to correct low to moderate myopia, suggesting foldable pIOL implantation maintains the cornea's prolate shape better.

Comparison of wavefront-guided photorefractive keratectomy and foldable iris-fixated phakic intraocular lens implantation for low to moderate myopia

To compare and evaluate the visual and refractive outcomes of myopic wavefront-guided photorefractive keratectomy (PRK) and foldable phakic intraocular lens (pIOL) implantation for myopia. Department of Ophthalmology, Haaglanden Medical Center, The Hague, The Netherlands. Comparative case series. The differences in visual acuity and residual refractive outcomes after wavefront-guided PRK and Artiflex foldable pIOL implantation were compared in eyes with low to moderate myopia (spherical error -4.0 to -7.0 diopters [D]; maximum cylinder 2.25 D). One-year follow-up results are presented. At 1 year postoperatively, the mean decimal Snellen uncorrected distance visual acuity was 1.05 ± 0.21 (SD) in the PRK group (60 eyes) and 1.04 ± 0.21 in the pIOL group (33 eyes) and the mean corrected distance visual acuity (CDVA), 1.21 ± 0.18 and 1.24 ± 0.13, respectively. In the PRK group, 21.7% of eyes lost 1 to 3 lines of CDVA and 11.7% of eyes gained 1 or 2 lines. In the pIOL group, no eye lost lines of CDVA and 42% gained 1 or 2 lines. At 1 year, 80.0% of eyes in the PRK group and 90.9% of eyes in the pIOL group were within ± 0.50 D of the spherical equivalent. There were no statistically significant differences in safety and efficacy between the pIOL group and the PRK group at 1 year. However, the percentage of eyes that gained lines of CDVA was significantly higher in the pIOL group.