Angle-supported Phakic Intraocular Lens Research Articles

Five Years Follow-Up of Acrysof Cachet® Angle-Supported Phakic Intraocular Lens Implantation for Myopia Correction.

Purpose The Acrysof Cachet® angle-supported phakic intraocular lens (pIOL) (Alcon Laboratories, Inc., Fort Worth, TX) is designed to correct high refractive errors in human eyes. The aim of this study was to evaluate the outcome of AcrySof Cachet® angle-supported pIOL implantation with particular regard to efficacy and safety of the implant over a 60-month follow-up period. Design Retrospective consecutive clinical case study. Methods Prior to pIOL implantation, patients had a complete ophthalmologic examination including objective and subjective refraction, uncorrected visual acuity (UCVA) and corrected distance visual acuity (CDVA), endothelial cells density (ECD), slit lamp photography, optical coherence tomography (OCT), Scheimpflug digital videokeratoscopy, optical biometry, slit lamp examination, intraocular pressure (IOP) measurement, and pupillometry. Postoperatively, patients received yearly a complete eye examination. Results Thirty-one eyes of 16 patients were included in this study. The mean age was 36.2 ± 8.1 years. UCVA (logMAR) improved from 1.33 ± 0.20 before surgery to 0.08 ± 0.14 one year after surgery and was 0.20 ± 0.20 five years after surgery. CDVA (logMAR) improved from 0.10 ± 0.10 before surgery to 0.05 ± 0.13 one year after surgery and was 0.04 ± 0.14 five years postoperatively. The mean percentage of endothelial cells loss (ECL) was 11.51% over the first year and 15.95% five years after surgery. There were no intraoperative complications in any of the eyes. Conclusions Our results up to five years after implantation of the AcrySof Cachet® angle-supported pIOL demonstrated very good outcomes in all above shown measurements, including CDVA, UCVA, and ECD. However, since major endothelial cell loss may occur in some patients with this type of pIOL, regular follow-up visits are required.

Long-term safety follow-up of an anterior chamber angle-supported phakic intraocular lens

To report adverse device effects and annualized endothelial cell loss rate for up to 10years after implantation of the Acrysof L-series Cachet phakic intraocular lens (pIOL). Clinical centers in the United States, European Union, and Canada. Nonrandomized clinical trial. After implantation of the pIOL, the endothelial cell density (ECD) at follow-up evaluations was compared with the 6-month postoperative baseline. Adverse device effects were assessed. This study assessed 638 patients (1087 eyes) from previous clinical trials. The mean central ECD change from baseline was -9.6%±8.3% (SD) (-1.7% annualized; 623 eyes) and -11.0%±9.9% (-1.7% annualized; 703 eyes) at 6years and 7years, respectively. The mean peripheral ECD change from baseline was -10.8%±8.7% (-2.0% annualized; 615 eyes) and -11.9%±10.0% (-1.8% annualized; 680 eyes), respectively. Endothelial cell loss greater than 30% from the preoperative baseline at any time after implantation affected 8.0% of all eyes. An ECD of 1500cells/mm2 or less at any time after implantation affected 2.7% of all eyes. The most common adverse device effects were peripheral iris adhesions (57 eyes [5.2%]), corneal endothelial cell loss (42 eyes [3.9%]), and pIOL explantation (37 eyes [3.4%]). Long-term evaluation of the pIOL showed a persistent ECD decrease in some eyes that was numerically larger than the annual rate expected with aging. Endothelial cell loss resulted in explantation in 3.1% of all eyes with the pIOL. Patients had no permanent vision loss. The manufacturer recommends that patients continue to be monitored and their corneal endothelium evaluated semiannually.

Оценка параметров переднего отрезка глаза методом оптической когерентной томографии у пациентов с высокой миопией, корригированной факичной интраокулярной линзой

Purpose . To assess anatomic topographic parameters of the anterior chamber of the eye in patients with high myopia corrected with the angle-supported phakic intraocular lens (PIOL) of the Cachet design using the anterior segment optical coherence tomography (AS-OCT). Material and methods . Seventeen highly myopic patients (31 eyes) corrected with angle-supported PIOL Cachet (Alcon) were examined in the period from September 2010 to December 2013. Mean age of the patients was 25.8±4.6 years. Mean spherical equivalent was -12.38±3.64D. All patients underwent comprehensive preand post-operative examinations, including the AS-OCT (Visante OCT, Carl Zeiss Meditec AG). Preoperatively the horizontal and vertical anterior chamber diameters (Angle-toAngle, ATA) were measured and the anterior chamber depth (from corneal epithelium and endothelium) using the AS-OCT. Also 3-12 months postoperatively the following parameters were assessed: «PIOL – corneal endothelium» (central), «PIOL – natural lens» (central) and «PIOL edge – corneal endothelium» (temporal and nasal). Results . The mean preoperative horizontal and vertical anterior chamber diameters were 12.07±0.38mm and 12.46±0.44mm, respectively (P<001). The mean preoperative anterior chamber depth values from corneal epithelium and corneal endothelium were 3.88±0.31mm and 3.36±0.33mm, respectively. Mean distance «PIOL – corneal endothelium» was 2.19±0.19mm, «PIOL – natural lens» – 0.92±0.15mm, temporal «PIOL edge – corneal endothelium» – 1.55±0.18mm and nasal «PIOL edge – corneal endothelium» – 1.53±0.18mm. In 10 of 31 eyes (6 of 16 patients) it was found that both the nasal and the temporal «PIOL edge – corneal endothelium» parameters were below 1.5mm. Using the step method of linear discriminant analysis a formula (reliable with P<0.005) and a simplified algorithm were calculated to predict the risk of a «dangerous» Cachet PIOL position in the anterior chamber of the eye. Based on our own clinical material a priori sensitivity and specificity of this formula were 100% and 95%, respectively. Conclusion . The current study showed that the existing patient selection criteria for the Cachet PIOL do not provide its safe position in some cases. The new prediction formula and algorithm allow timely identifying patients at risk early to enhance the efficiency and safety of this high myopia correction method.

Asymptomatic haptic migration of phakic anterior chamber intraocular lens through the peripheral iridectomy

ObjectiveCase series of haptic migration in patients with angle-supported phakic anterior chamber intraocular lens (PAC-IOL: Phakic6H) through the superior peripheral iridectomy (PI). MethodsCharts of 23 patients (35 eyes) with at least 6 months’ postoperative follow-up were retrospectively reviewed. Evaluation included preoperative and postoperative cycloplegic and manifest refractions, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), slit-lamp examination, fundoscopy, corneal topography, and biometry. ResultsMean UCVA was 1.67 ± 0.30 (1.17–2.00) for all 35 eyes preoperatively and 0.35 ± 0.25 (0.00–1.00) postoperatively (p < 0.001; 95% CI 1.21–1.44). BCVA had a mean of 0.31 ± 0.26 for all 35 eyes preoperatively, and a mean of 0.22 ± 0.25 postoperatively (p < 0.001; 95% CI 0.04–0.14). Haptic migration into the superior PI was noted in 8 eyes (23%). The first migration was noted 2 years postoperatively and the last 8 years after implantation (mean, 5.6 ± 2 years). There was no statistically significant difference in the BCVA and UCVA before and after haptic migration. Follow-up ranged from 8 months to 8.5 years. ConclusionsAngle-supported PAC-IOL implantation resulted in significant improvement in both UCVA and BCVA. However, there is a 23% incidence of haptic migration in our series with no sequelae on BCVA or harmful effect on the intraocular structures. This IOL movement may be explained by changes in aqueous dynamics at the level of the PI leading to migration of the haptic into the area of least resistance. ObjectifÉtudier des cas de migration de l’haptique dans le site de l’iridectomie périphérique (IP) supérieure après l’implantation de lentilles intraoculaires phaques (LIOP) à support angulaire dans la chambre antérieure (Phakic 6H®). MéthodesOn a examiné rétrospectivement les dossiers de 23 patients (35 yeux) ayant fait l’objet d’au moins 6 mois de suivi postopératoire. Éléments évalués: réfraction sous cycloplégie et réfraction manifeste préopératoires et postopératoires, acuité visuelle non corrigée (AVNC), meilleure acuité visuelle corrigée (MAVC), examen à la lampe à fente, fondoscopie, topographie cornéenne et biométrie. RésultatsL’AVNC moyenne était de 1,67 ±0,30 (1,17-2,00) avant l’intervention et de 0,35 ±0,25 (0,00-1,00) après l’intervention (P <0,001; IC 95 %, 1,21-1,44). La MAVC moyenne était de 0,31 ± 0,26 avant l’intervention et de 0,22 ± 0,25 après l’intervention (P <0,001; IC 95 %, 0,04-0,14). Il y a eu migration de l’haptique dans le site de l’IP supérieure pour 8 yeux (23 %). La première migration a été notée 2 ans après l’intervention et la dernière, 8 ans après l’implantation (moyenne de 5,6 ± 2 ans). Il n’y avait pas d’écart statistiquement significatif entre les MAVC et les AVNC avant et après la migration de l’haptique. La durée du suivi allait de 8 mois à 8,5 ans. ConclusionsL’implantation de LIOP à support angulaire dans la chambre antérieure a donné lieu à une amélioration significative de l’AVNC et de la MAVC. Cependant, il y a eu parmi les cas étudiés une incidence de 23 % de migration de l’haptique, sans séquelles pour la MAVC ni effet nocif sur les structures intraoculaires. Le déplacement des LIO pourrait découler de variations de la dynamique aqueuse au niveau de l’IP, entraînant une migration de l’haptique vers l’endroit où la résistance est la moindre.

Correction of Moderate to High Myopia with a Foldable, Angle-Supported Phakic Intraocular Lens: Results from a 5-Year Open-Label Trial

To evaluate the 5-year efficacy of a foldable, hydrophobic, angle-supported phakic intraocular lens (pIOL) when used to correct moderate to high myopia. Prospective, nonrandomized, multicenter, open-label cohort study conducted in the United States, the European Union, and Canada (3 separate protocols). This was a pooled analysis of 515 eyes from 360 patients 18 to 49 years of age with moderate to high myopia (preoperative corrected distance visual acuity [CDVA] ≤0.34 logarithm of the minimum angle of resolution [logMAR]) and with variance in the manifest refraction spherical equivalent within ±0.5 diopter (D) for a minimum of 12 months. Implantation of the AcrySof Cachet angle-supported anterior chamber pIOL (Alcon Laboratories, Inc., Fort Worth, TX). Uncorrected distance visual acuity (UDVA), CDVA, predictability and stability of manifest refraction spherical equivalent (MRSE), serious adverse events, endothelial cell density, and patient satisfaction. Of 360 patients who received implantation in at least 1 eye (515 eyes), 326 (90.6%) completed the study (5-year best-corrected visual acuity data available for 415 eyes). At 5 years, a decrease in CDVA of 2 lines or more was observed in 0.5% of eyes (n= 2/415) compared with preoperative baseline. At 5 years, all 415 eyes achieved a CDVA of 0.34 logMAR or less; 91.3% (n= 379/415) had a CDVA of 0.04 logMAR or less. Mean UDVA ± standard deviation (SD) was 0.01±0.18 logMAR; 94.7% (n= 393/415) and 66.3% (n= 275/415) of eyes had a UDVA of 0.34 logMAR or less or 0.04 logMAR or less, respectively, at 5 years. Mean MRSE ± SD was-0.34±0.57 D (range,-2.50 to 1.63 D). Most eyes (89.8%; n= 371/413) had an MRSE within ±1.00 D of their target refractive error at 5 years and 67.3% (n= 278/413) were within ±0.50 D. Mean annualized central endothelial cell loss was 1.46% (90% confidence interval [CI],-1.6% to-1.3%) from 6 months to 5 years. The most common pIOL-related serious adverse event was adhesion between the cornea and the iris (synechia; n= 24). Most patients (98.1%) indicated that they would have the same pIOL implanted again. In patients with moderate to high myopia, the AcrySof Cachet angle-supported pIOL provided excellent refractive correction for up to 5 years after implantation, with a low rate of mean central endothelial cellloss. Careful patient selection is necessary to achieve optimal postsurgical outcomes.

Angle-supported phakic intraocular lenses for the correction of myopia: Three-year follow-up

To evaluate patient safety and refractive outcomes in eyes with an angle-supported phakic intraocular lens (pIOL), and to assess the correlation between rotation and corneal endothelial cell damage. Gimbel Eye Centres, Calgary and Edmonton, Alberta, Canada. Retrospective cohort study. This study included patients with moderate to high myopia (range -6.50 to -19.50 diopters [D]) who received the Acrysof Cachet pIOL. Outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity, manifest refraction spherical equivalent (MRSE), endothelial cell density (ECD), and IOL rotation. This study evaluated 119 eyes of 61 patients. The mean ECD decrease from preoperative measurements was 3.11% (n = 46), with a mean IOL rotation of 10.6 degrees (n = 35) at the 3-year postoperative visit. Of the 49 eyes at the 3-year visit measured for UDVA, 98.0% were 20/40 or better and 77.6% were 20/20 or better. The MRSE improved from a preoperative mean of -9.26 diopters (D) ± 2.43 (SD) (range -19.50 to -5.63 D) to -0.33 ± 0.61 D (range -3.12 to +0.71 D) at the 3-year visit. The residual refractive error was within ±0.50 D of the target refraction for 78.4% and within ±1.00 D for 92.2% of the 51 eyes. The study included one bilateral pIOL removal due to endothelial cell loss, one case of synechia, and one case of subtle pupil ovalization. No correlation between IOL rotation and ECD decrease was found (R(2) = 0.0143); the pIOL provided promising refractive outcomes and acceptable safety in patients with moderate to high myopia. No author has a financial or proprietary interest in any material or method mentioned.

Phakic intraocular lens explantation: causes in 240 cases.

To describe the main causes of explantation of phakic intraocular lenses (PIOLs) according to the anatomical site of implantation (angle supported, iris fixated, or posterior chamber). This multicentric, retrospective, and consecutive study sponsored by the Spanish Ministry of Health comprised a total of 240 eyes (226 patients) explanted due to PIOL complications. Clinical data of 144 angle-supported lenses, 24 iris-fixated lenses, and 72 posterior chamber lenses explanted were recorded preoperatively and postoperatively. Mean age of the patients at explantation was 46.30 ± 11.84 years (range: 25 to 80 years). The mean time between implantation and explantation was 381.14 ± 293.55 weeks (range: 0.00 to 1,551.17 weeks). It was 422.33 ± 287.81 weeks for the angle-supported group, 488.03 ± 351.95 weeks for the iris-fixated group, and 234.11 ± 4,221.60 weeks for the posterior chamber group. It was 8.10 ± 5.52 years for the angle-supported group, 9.36 ± 6.75 years for the iris-fixated group, and 4.49 ± 4.25 years for the posterior chamber group. This period of time was significantly shorter in the posterior chamber group (P < .001). Overall, the main causes of explantation were cataract formation (132 eyes, 55%), endothelial cell loss (26 eyes, 10.83%), corneal decompensation (22 eyes, 9.17%), PIOL dislocation/decentration (16 eyes, 6.67%), inadequate PIOL size or power (12 eyes, 5%), and pupil ovalization (10 cases, 4.17%). Cataract development was the cause of explantation in 51.39% of angle-supported cases, 45.83% of iris-fixated cases, and 65.28% of posterior chamber cases. Endothelial cell loss was the cause of explantation in 15.97% of angle-supported PIOLs, 8.33% of iris-fixated PIOLs, and 1.39% of posterior chamber PIOLs. Cataract is the main cause of PIOL explantation, especially in posterior chamber PIOLs. In the angle-supported group, endothelial cell loss was the second cause of explantation.

Simultaneous corneal crosslinking and surface ablation combined with phakic intraocular lens implantation for managing keratoconus.

To assess the efficacy and stability of simultaneous topography-guided photorefractive keratectomy (PRK) and crosslinking (Athens protocol) followed by phakic intraocular lens (IOL) implantation for managing keratoconus. Ain-Shams University, Cairo, Egypt. Prospective non-randomized study. All patients underwent topography-guided PRK followed immediately by collagen crosslinking (Athens protocol), 2-4 months later, eyes were implanted with either an iris claw or an angle-supported phakic IOL. Statistical analysis was performed with SigmaPlot software version 11.0 (Systat Software, Inc.). This study evaluated 22 eyes of 14 patients. Follow-up interval was at least 6 months. A Veriflex phakic IOL was implanted in 14 eyes (63.6 %), and a Cachet phakic IOL was implanted in 8 eyes (36.4 %). The mean preoperative keratometric reading (45.57 ± 1.51 D) was significantly reduced at 3 months and at 6 months after treatment (43.82 ± 1.98 D, P < 0.001). The mean spherical equivalent was significantly reduced from -9.08 ± 2.5 to -0.69 ± 0.67 D, P = <0.001. The mean UCVA improved from 1.24 ± 0.49 to 0.37 ± 0.08 logMAR. The mean corrected distance visual acuity (CDVA; logMAR) improved from 0.69 ± 0.3 preoperatively to 0.35 ± 0.01 postoperatively (P = <0.001). At last follow-up, all eyes could achieve CDVA of 0.3 or better. The difference between pre- and postoperative endothelial cell counts was not statistically significant. Combining phakic IOLs and the Athens protocol improved and stabilized visual performance in patients with keratoconus. These results justify a future, large-scale study with a longer follow-up.

Follow-up Study of More Than 15 Years of an Angle-Supported Phakic Intraocular Lens Model (ZB5M) for High Myopia

This study confirmed the long-term outcomes of the ZB5M phakic intraocular lens (PIOL). To evaluate the potential long-term risk associated with ZB5M PIOL implantation. A retrospective, nonrandomized, consecutive cohort study of a total of 208 eyes implanted with ZB5M PIOLs at VISSUM Corporación Oftalmológica de Alicante between 1990 and 1996 identified through surgical records (208 eyes of 123 patients); 50 of these patients (97 eyes) had available records and follow-up. ZB5M PIOL implantation. To evaluate the incidence and onset of each complication during the follow-up and risk factors and causes for loss of visual acuity. Mean (SD) preoperative spherical equivalent refraction was -19.36 (6.7) diopters and at the end of follow-up, it was -1.4 (2.6) diopters. Mean (SD) best-corrected visual acuity at the preoperative visit was 0.35 (0.2) decimal and at the end of follow-up, 0.56 (0.3) decimal. Mean (SD) endothelial cell density preoperatively and at the end of follow-up was 2783 (787) cells/mm(2) and 1921 (672) cells/mm(2), respectively. The incidence of cataract during the follow-up was 0.010 eye-year (EY); cornea decompensation, 0.001 EY; ocular hypertension, 0.008 EY; pupil ovalization, 0.020 EY; uveitis, 0.001 EY; and retinal detachment, 0.002 EY. To our knowledge, this is the first study that describes the long-term outcomes and complications of ZB5M PIOLs and suggests increasing the postoperative follow-up examinations in patients older than 40 years, analyzing anterior chamber modifications, and recommends PIOL explantation in cases of an increase in the crystalline size.

Phakic intraocular lenses: past and present

Phakic intraocular lenses (IOLs) are gaining popularity for refractive surgeons, since these IOLs are easy to implant and can correct high ametropia up to 20 D. However, these implants can still lead to reversible and irreversible complications, even years after implantation. This review gives a short overview about the different kinds of phakic IOLs, the advantages and disadvantages of these lenses and the pre- and post-operative examinations. Most of the angle-supported phakic IOLs have been abandoned from the market few years after launching. Two anterior chamber IOLs and one posterior chamber IOL—the iris-clip IOL ‘Artisan/Verisyse’ (Ophtec, Netherlands/Abbott, USA), the angle supported IOL ‘Cachet’ (Alcon, USA) and the ‘implantable collamer lens’ (Staar, USA), are commercially available at the moment. Phakic IOLs are a good option for the treatment of high myopia, but exact preoperative examination of the patient and consistent post-operative controls including endothelial cell count are mandatory to reduce the risk of long-term complications.

Anterior Segment Optical Coherence Tomography of Long-Term Phakic Angle-Supported Intraocular Lenses

To evaluate the long-term age-related anterior chamber changes by anterior segment optical coherence tomography (OCT) and the impact of such changes on the stability and behavior of angle-supported phakic intraocular lenses (IOLs). A retrospective consecutive observational cohort study. A total of 23 eyes with high myopia implanted with an angle-supported phakic IOL between 1990 and 1996 at Vissum Corporación Oftalmológica de Alicante were included in the study. Patients were evaluated using OCT. Anterior chamber depth, anterior chamber width, crystalline lens rise, and the distance between phakic IOL and endothelium were measured. Fifteen years after implantation, anterior chamber depth was 2.9 ± 0.3 mm, crystalline lens rise 748.18 ± 393.13 μm, and phakic IOL-endothelium distance 2.1 ± 0.30 mm. The predictive model showed that 30 years after implantation, endothelial cell count was less than 600 cells/mm(2) in patients with a preoperative spherical equivalent of -25 diopters (D). Twenty years after implantation, the safety zone of 1.5 mm between endothelium and the lens will not be respected in patients with a preoperative spherical equivalent of -20 D. The findings of this study could have an important influence on the decision about the indication to implant angle-supported phakic IOLs in young patients with a long postoperative life expectancy, as age-related changes in the anatomy of the anterior segment may create a long-term hazard for the implanted eye.

Rotation Stability of the Cachet Angle-Supported Phakic Intraocular Lens

To evaluate the rotational stability of an acrylic angle-supported phakic intraocular lens (PIOL) 12 months after implantation in myopic eyes. Patients with a history of moderate to high myopia underwent unilateral or bilateral implantation of an acrylic angle-supported PIOL (AcrySof Cachet; Alcon Laboratories, Inc., Fort Worth, TX). All were followed up for 12 months. IOL rotation was assessed using digital overlay of ocular photographs captured within 2 weeks of implantation and at postoperative month 12. The secondary outcomes of refractive power (spherical equivalent, refractive sphere, and cylinder) and uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were assessed preoperatively and again at 3 months after implantation. Fifty eyes of 28 patients with a mean age of 32 years were included in this retrospective cohort study. All underwent successful IOL implantation and follow-up. A mean 12-month rotation of 11° was observed (standard deviation: 15.1°, range: 0 to 60°). All preoperative measures (mean) of refractive power improved by 3 months postoperatively (spherical equivalent = -0.35 ± 0.79 diopters [D], spherical refraction = 0.04 ± 0.82 D, and cylindrical refraction = -0.77 ± 0.91 D). Two percent of eyes requiring additional laser adjustment by postoperative month 12, primarily due to corneal astigmatism. The study findings suggest that AcrySof Cachet angle-supported PIOLs offer moderate 1-year rotational stability. Because this type of IOL also corrects myopia effectively, it appears to be a good treatment option for myopic eyes. However, the rotation that occurs makes it unsuitable for cylinder corrections.

Dynamic Positional Change and Defocus Curve of a Phakic Foldable Anterior-Chamber Angle-Supported Intraocular Lens during Accommodation

To evaluate movements of an anterior-chamber angle-supported phakic intraocular lens (PIOL) Cachet (Alcon, Fort Worth, Texas) and their influence on visual acuity during accommodation. Prospective case series. We included 54 eyes of 27 patients (15 female, 12 male; age, 38 ± 7.61 years; preoperative manifest spherical equivalent -8.7 ± 2.5 diopters [D]). Evaluation of the PIOL's positional stability (distance to the corneal endothelium [M1] and the natural lens [M2]) as well as the pre- and postoperative anterior chamber depth (ACD) and pupil diameter (PD). Measurements were performed for accommodation stimuli ranging from -7 to +1 D in 1-D increments using optical coherence tomography (Visante OCT, Carl Zeiss Meditec, Jena, Germany). The respective defocus curve was evaluated using Early Treatment Diabetic Retinopathy Study charts. Statistical analysis included a Kolmogoroff-Smirnov test for parametric distribution, a Friedman- and consecutive Conover-Iman-Bonferroni test for detection of PD, ACD, and defocus curve differences from before to after the operation, a 1-sided t test for analysis of positional changes (ΔPD, ΔACD, and ΔM values compared with a zero stimulus position), and a regression analysis for the evaluation of influence of age, IOL diameter, and power on Δ-values. Significance was set at P = 0.05. Postoperative ΔM values. The PD, ΔPD, ACD, and ΔACD did not differ significantly between pre- and postoperative values. The ΔM1 and ΔM2 differed significantly from the zero-stimulus position for defocus stimuli of ≥-3 D and ≥-2D, respectively; mean ΔM1max was -0.09 ± 0.06 mm for -7-D stimulus; mean ΔM2max was -0.09±0.10 mm for -5-/-6-D stimulus. Apart from ΔPD, all Δ-values decreased with age. Visual acuity was significantly better postoperatively for defocus stimuli between 0 and -3 D. The anterior-chamber angle-supported PIOL changes its position during accommodation only marginally. The PIOL does not affect postoperative accommodation.

OPTICAL AND FUNCTIONAL PERFORMANCE OF PHAKIC ANGLE-SUPPORTED INTRAOCULAR LENS FOR THE CORRECTION OF HIGH MYOPIA IN 18-MONTHS FOLLOW-UP STUDY

To investigate the safety, the efficacy and stability of the AcrySof phakic angle-supported intraocular lens (IOL) (Alcon Laboratories, Inc., Fort Worth, TX) for correction of moderate-to-high myopia in adults. 12 patients (18 eyes) with moderate-to-high myopia underwent implantation of the AcrySof phakic angle-supported IOL. Best spectacle-corrected visual acuity (BSCVA), uncorrected distance visual acuity (UCVA), predictability and stability of mean manifest refraction spherical equivalent (MRSE), adverse events, endothelial cell density, corneal and total ocular aberrations and rotation of the IOL were measured. The mean follow-up was 18 months (± 4 months). At 18 months, the mean UDVA was 0.83 and the mean BSCVA was 0.97. The mean MRSE was -0.29 D. The mean percentage change in central endothelial cell density 18 months after surgery was -3.4%. No adverse events were observed. Wavefront measurements revealed a significant reduction in terms of high order aberrations between pre-operative and post-operative 18 months values. The analysis of the rotation showed a little variation (mean rotation of 5.4°) between postoperative 1 month and postoperative 18 months visits. The AcrySof phakic angle-supported IOL yielded excellent refractive correction and predictability with optimal safety. The study demonstrates preliminary support for an high stability of the IOL at 18 months follow-up.

OPTICAL AND FUNCTIONAL PERFORMANCE OF PHAKIC ANGLE-SUPPORTED INTRAOCULAR LENS FOR THE CORRECTION OF HIGH MYOPIA IN 18-MONTHS FOLLOW-UP STUDY

To investigate the safety, the efficacy and stability of the AcrySof phakic angle-supported intraocular lens (IOL) (Alcon Laboratories, Inc., Fort Worth, TX) for correction of moderate-to-high myopia in adults. 12 patients (18 eyes) with moderate-to-high myopia underwent implantation of the AcrySof phakic angle-supported IOL. Best spectacle-corrected visual acuity (BSCVA), uncorrected distance visual acuity (UCVA), predictability and stability of mean manifest refraction spherical equivalent (MRSE), adverse events, endothelial cell density, corneal and total ocular aberrations and rotation of the IOL were measured. The mean follow-up was 18 months (&plusmn; 4 months). At 18 months, the mean UDVA was 0.83 and the mean BSCVA was 0.97. The mean MRSE was -0.29 D. The mean percentage change in central endothelial cell density 18 months after surgery was -3.4%. No adverse events were observed. Wavefront measurements revealed a significant reduction in terms of high order aberrations between pre-operative and post-operative 18 months values. The analysis of the rotation showed a little variation (mean rotation of 5.4&deg;) between postoperative 1 month and postoperative 18 months visits. The AcrySof phakic angle-supported IOL yielded excellent refractive correction and predictability with optimal safety. The study demonstrates preliminary support for an high stability of the IOL at 18 months follow-up.

Clinical research of the phakic foldable angle-supported intraocular lens for the correction of high myopia

To assess the safety, efficacy, predictability and stability of the phakic foldable angle-supported intraocular lens (IOL) (CACHET IOL, Alcon Inc., USA.) for correction of high-to-extremely high myopia in adults. In this prospective study, 29 eyes of 15 patients were implanted with CACHET phakic angle-supported IOL and followed for 1 year postoperatively. Preoperative manifest refractive sphere was -12.08 ± 2.44 diopters (D). Visual acuity(uncorrected visual acuity, UCVA; best spectacle-corrected visual acuity, BSCVA), predictability and stability of manifest refraction spherical equivalent (MRSE), adverse events, and endothelial cell density were analyzed primarily during 1-year of follow-up. After 1 year of follow-up, a BSCVA of 0.6 or better was achieved by 100% of eyes; 9.7% (26/29) had a BSCVA of 1.0 or better; no eyes lost ≥ 1 line BSCVA, 62.1%(18/29) had no change in lines of BSCVA, 31.0% (9/29) gained 1 line of BSCVA, 3.4% (1/29) gained 2 line of BSCVA, and 3.4% (1/29) gained more than 2 line of BSCVA; the safety index was 1.13 (1.08/0.96); UCVA of 1.0 or better was achieved by 58.6% (17/29), 100% had an UCVA of 0.5 or better, 86.2% (25/29) of eyes achieved a UCVA of 0.8 or better, and 93.1% (27/29) of eyes achieved a UCVA of 0.6 or better; the efficacy index was 1.03(0.99/0.96). The overall mean percentage change in endothelial cell density 1 year after surgery was -0.23% ± 4.80%. Five eyes (17.2%) had increased intraocular pressure (IOP) on the day of surgery. No pupil ovalization, pupillary block, or retinal detachment events were observed. Glare (6.9%, 2/29) and halo (13.8%, 4/29) mainly appeared in the first month after surgery, and had no influence on driving in night. After 1 year of follow-up, the implantation of phakic foldable angle-supported IOL was proved to be safe, effective and predictable with minimal complications in patients with high myopia. Due to the limitation of visiting time, long-term of clinical investigation is necessary to verify the safety and efficacy of this IOL.

Femtosecond-Assisted Keratopigmentation Double Tunnel Technique in the Management of a Case of Urrets-Zavalia Syndrome

To describe the successful use of a double intrastromal tunnel femtosecond-assisted keratopigmentation technique to manage a case of unilateral Urrets-Zavalia syndrome. A 33-year-old man was referred with a history of trauma in his right eye due to a labor-related accident. Because of myopic anisometropia, he had been previously implanted with an angle-supported phakic intraocular lens. The patient presented iris atrophy and a fixed dilated pupil. He complained of severe and incapacitating photophobia, glare, and decreased vision. To obtain a complete iris replica, the surgery involved creation of double keratopigmented intrastromal tunnels using femtosecond laser and micronized mineral pigments. The deepest layer was stained black first and then the superficial layer was stained with a contoured greenish blue-gray color, which matched the contralateral eye. In the immediate postoperative period, the patient reported a complete elimination of photophobia associated with the corrected distance visual acuity improvement. A very adequate cosmetic outcome was also achieved. Stability was observed during the 12-month follow-up. A femtosecond-assisted keratopigmentation technique using 2 pigmented intrastromal tunnels to achieve an intracorneal pigmented replica of the iris was effective in improving the patient's severe visual function disability and cosmetic appearance. To the best of our knowledge, this is the first report of severe visual function disability caused by atrophic iris and a fixed dilated pupil treated with double intrastromal layers of keratopigmentation by means of femtosecond-created tunnels.

Visual and aberrometric outcomes in eyes with an angle-supported phakic intraocular lens

To evaluate the postoperative changes in spherical aberration and the point-spread function (PSF) induced by the implantation of a new angle-supported phakic intraocular lens (pIOL). Department of Ophthalmology, St. Bassiano Hospital, Bassano del Grappa, Italy. Prospective nonrandomized cohort study. Eyes with high myopia had implantation of an Acrysof Cachet angle-supported pIOL. Preoperative and postoperative total spherical aberration and PSF were measured using a Luneau 80 Wave+ wavefront aberrometer (high-resolution Hartmann-Shack technology) at a fixed entrance pupil scan size of 5.0 mm under pharmacologic mydriasis. Preoperative and postoperative data were analyzed and compared using the Student t test. Thirty-five eyes of 18 patients were included in the statistical analysis. The Student t test for paired data (95% confidence interval) showed a statistically significant difference between preoperative data and postoperative data. The mean preoperative total spherical aberration Z(4,0) was -0.001 μm ± 0.076 (SD) preoperatively and -0.13 ± 0.11 μm postoperatively (P≤.05). The mean PSF was 0.28 ± 0.15 preoperatively and 0.34 ± 0.16 postoperatively (P<.05). Implantation of the angle-supported pIOL in eyes with high myopia improved the quality of vision, inducing negative spherical aberration and increasing the PSF under mesopic conditions.

AcrySof phakic angle-supported intraocular lens for the correction of high to extremely high myopia: one-year follow-up results.

To assess the safety, efficacy and predictability of the AcrySof phakic angle-supported intraocular lens (IOL) (Alcon Inc., U.S.A.) for correction of high-to-extremely high myopia in adults. In this prospective study performed in Tianjin Medical University Eye Center & College of Optometry, Tianjin, China, 25 eyes of 13 patients were implanted with AcrySof phakic angle-supported IOLs and followed for 1 year postoperatively. Preoperative manifest refractive sphere was (-12.08±2.44) diopters (D) and cylinder was (-1.35±0.62)D. Visual acuity, predictability and stability of manifest refraction spherical equivalent (MRSE), adverse events, and endothelial cell density were analyzed during 1-year of follow-up. After 1 year of follow-up, no eyes lost≥1 line (best spectacle-corrected visual acuity)BSCVA; an uncorrected visual acuity (UCVA) of 20/20 or better was achieved in 60% of eyes; 100% had an UCVA of 20/40 or better; a BSCVA of 20/30 or better was achieved by 100% of eyes; 84% had a BSCVA of 20/20 or better. The overall mean percentage change in endothelial cell density 1 year after surgery was (-0.27±3.60)%. Two eyes (8%) had increased intraocular pressure (IOP) on the day of surgery. No pupil ovalization, pupillary block, or retinal detachment events were observed. After 1 year of follow-up, the implantation of AcrySof phakic angle-supported IOL is proved to be safe, effective and predictable with minimal complications in patients with high-to-extremely high myopia. Due to the limitation of visiting time, long-term of clinical investigation is necessary to verify the safety and efficacy of this IOL.

AcrySof Cachet Phakic Intraocular Lens in Myopic Patients: Visual Performance, Wavefront Error, and Lens Position

To evaluate visual and aberrometric outcomes and position of the AcrySof Cachet (Alcon Laboratories Inc) angle-supported phakic intraocular lens (PIOL) for correction of myopia in adults. This prospective study included 36 consecutive eyes with moderate to high myopia in which an AcrySof Cachet PIOL was implanted to minimize refractive error. Follow-up was up to 1 year. Mean manifest spherical equivalent refraction reduced significantly from -14.90 ± 0.90 diopters (D) to -0.29 ± 0.30 D at 1 month and remained stable at 1 year (P<.001). Mean uncorrected distance visual acuity was >0.1 logMAR (20/20 Snellen) in 56% of patients and >0.3 logMAR (20/25 Snellen) in 100% of patients. Corrected distance visual acuity was >0.1 logMAR (20/20 Snellen) in 78% of patients and >0.3 logMAR (20/25 Snellen) in 100% of patients. Mean endothelium-PIOL distance and mean PIOL-crystalline distance were within recommended values at all postoperative evaluations. Statistically significant variations for these variables were not observed. Anterior chamber depth, safety center distance, and vault center distance showed significant reduction after accommodation (P<.01). Anterior chamber depth and safety center distance significantly increased after pupil dilation (P<.01). Mean percentage of endothelial cell loss was 4.04% at 1 year. The root-mean-square of total higher order aberrations and spherical, coma, and trefoil aberrations did not change significantly from pre- to postoperatively. The AcrySof Cachet PIOL was effective in the correction of moderate to high myopia and provided excellent visual performance with no modification of physiologic ocular wavefront error. Adequate distance from the cornea and crystalline lens was maintained with no significant change during follow-up and under different environmental conditions.