Artiflex Toric foldable phakic intraocular lens: short-term results of a prospective European multicenter study.

PURPOSE: To evaluate the short-term efficacy, predictability, stability, and safety of the foldable Artiflex Toric phakic intraocular lens (pIOL; Ophtec) for the correction of myopia with astigmatism. DESIGN: Prospective, nonrandomized multicenter study. METHODS: One hundred fifteen eyes of 73 patients were implanted with an Artiflex Toric pIOL. Mean implanted spherical and cylindrical powers were -7.10 ± 2.70 diopters (D) and -2.14 ± 0.80 D, respectively. Total follow-up was 6 months. Outcome parameters included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), subjective manifest refraction (used for vector analysis), intraocular pressure, and endothelial cell density (ECD). RESULTS: At 6 months, 99.0% of eyes had a UCVA of ≥20/40, and 81.8% of eyes were ±0.5 D of the intended refraction. In 74.5% postoperative UCVA was equal to or better than preoperative BSCVA; 2 eyes lost 2 or more lines of BSCVA postoperatively because of the development of synechiae. In 75.5% of eyes the remaining cylinder was ±0.5 D. There was a significant decrease in ECD after 3 months (4.8% ± 11.9%), with no additional decline between 3 and 6 months. There were few complications, except for the incidence of pigment and nonpigment precipitates (14.8% and 12.2%, respectively at 6 months). Mean misalignment was 0.6 ± 1.5 degrees (range 0-8). CONCLUSIONS: The Artiflex Toric pIOL effectively and safely corrects myopia and astigmatism in the short term, with stable and predictable visual results after 6 months, when strict inclusion criteria are applied. Deposition of pigment and nonpigment precipitates on the pIOL warrants further investigation.

Foldable Artiflex phakic intraocular lens for the correction of myopia: two-year follow-up results of a prospective European multicenter study.

OBJECTIVE: To evaluate the safety, efficacy, predictability, stability, and complications of the foldable Artiflex iris-fixated intraocular lens (Ophtec BV, Groningen, The Netherlands) for the correction of myopia in phakic eyes. DESIGN: Prospective, nonrandomized, open-label, multicenter trial. PARTICIPANTS: Two hundred ninety eyes of 191 patients aged 18 to 60 years with average spherical equivalent of -7.33+/-2.60 diopters (D; range, -12.63 to -1.5 D) were analyzed. METHODS: All eyes underwent implantation of the foldable iris-fixated Artiflex phakic intraocular lens (PIOL) with an optic zone of 6 mm. The follow-up was 2 years. Phakic intraocular lenses were implanted in powers ranging from -2.0 to -12.0 D. MAIN OUTCOME MEASURES: The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), refraction, and endothelial cell count. RESULTS: After 2 years, a UCVA of 20/40 or better was observed in 97.2% of eyes. The BSCVA was 20/40 or better in all eyes. A gain of 1 line or more of BSCVA was found in 49.9% of eyes, and 0.8% lost 2 or more lines. The mean endothelial cell change was -0.05%, 1.79%, and -1.07% at 6 months, 1 year, and 2 years, respectively. Complications were comparable with complications that have been reported previously of the Artisan PIOL, the only exception being a higher incidence of iris pigment precipitates (4.8% at 2 years after surgery). CONCLUSIONS: After 2 years of follow-up, the implantation of the foldable iris-fixated Artiflex intraocular lens proved to be effective and predictable for the correction of myopia in phakic eyes.

Results of cataract surgery after implantation of an iris-fixated phakic intraocular lens.

PURPOSE: To report the results of cataract surgery after previous implantation of an Artisan iris-fixated phakic intraocular lens (pIOL) for the correction of myopia. SETTING: University center and private practice. METHODS: This study comprised eyes with previous implantation of an iris-fixated pIOL to correct myopia and subsequent pIOL explantation combined with cataract surgery and in-the-bag implantation of a posterior chamber IOL. Predictability of refractive results, changes in endothelial cell density (ECD), and postoperative best corrected visual acuity (BCVA) were analyzed. RESULTS: The mean follow-up after cataract surgery in the 36 eyes of 27 consecutive patients was 5.7 months +/- 7.5 (SD). The mean time between pIOL implantation and cataract surgery was 5.0 +/- 3.4 years. After explantation of the pIOL and subsequent cataract surgery, the mean spherical equivalent (SE) was -0.28 +/- 1.11 diopters (D); the SE was within +/-1.00 D of the intended correction in 72.2% of patients and within +/-2.00 D in 86.1% of patients. The mean endothelial cell loss after the combined procedure was 3.5% +/- 13.2% and the mean postoperative BCVA, 0.17 +/- 0.18 logMAR. CONCLUSIONS: In patients with a history of implantation of an iris-claw pIOL for the correction of myopia, cataract surgery combined with explantation of the pIOL yielded acceptable predictability of the postoperative SE and minimal loss of ECD, resulting in a gain in BCVA.

Long-term study of Artisan phakic intraocular lens implantation for the correction of moderate to high myopia: ten-year follow-up results.

PURPOSE: To determine the long-term performance of the Artisan phakic intraocular lens (PIOL) for the correction of myopia. DESIGN: Long-term (10 years) retrospective follow-up study. PARTICIPANTS: Eighty-nine eyes of 49 patients who underwent Artisan PIOL implantation for the correction of myopia. METHODS: Comparisons were made between preoperative clinical data and the clinical data at 1, 6, and 10 years after surgery. MAIN OUTCOME MEASURES: Refractive stability, refractive predictability, safety, efficacy, best-corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), intraocular pressure, intraoperative problems, corneal endothelial cell density, corneal endothelial cell loss, and glare levels were evaluated. RESULTS: The mean spherical equivalent (SE) after 10 years was -0.70+/-1.00 diopters (D; range, -4.00 to 2.00 D), with no significant change in mean SE between 1, 6, and 10 years. At 10 years, 68.8% of all eyes were within 1.0 D of the intended correction. At 10 years, 31.2% (n = 24) gained 1 or more Snellen lines of BCVA and 2.6% (n = 2) lost more than 2 Snellen lines of BCVA; 93.3% reached a BCVA of 20/40 or better, and 82.0% reached a UCVA of 20/40 or better. The mean intraocular pressure remained stable and was 15.5+/-3.5 mmHg (range, 7-25 mmHg) at 10 years. The mean endothelial cell loss was -8.86+/-16.01% (range, -51.69% to 34.43%) at 10 years. CONCLUSIONS: Long-term results demonstrate that the implantation of an Artisan PIOL for the correction of moderate to high myopia is a stable, predictable, and safe method when strict inclusion criteria for surgery are applied. There was no significant loss of corneal endothelial cells and no reports of long-term glare.

Toric phakic intraocular lens for the correction of hyperopia and astigmatism.

PURPOSE: To evaluate the Artisan toric phakic intraocular lens (pIOL) for the correction of hyperopia and astigmatism. SETTING: Department of Ophthalmology, Erasmus MC, Rotterdam, The Netherlands, and Department of Ophthalmology, Sint Truiden, Belgium. METHODS: In this prospective study of 47 eyes of 28 patients with hyperopia and astigmatism, Artisan toric pIOLs were implanted between April 1999 and June 2004. Uncorrected visual acuity (UCVA), best corrected visual acuity, refraction, astigmatism, safety, and predictability were analyzed. Change in astigmatism was analyzed with vector analysis. Refractive cylinders are expressed in minus form. RESULTS: Mean preoperative spherical equivalent was +4.33 diopters (D) +/- 2.26 (SD). Mean follow-up was 11.1 months (range 6 to 36 months). A gain of 1 or more lines in best spectacle-corrected visual acuity (BSCVA) was seen in 36.2%. Safety index and efficacy index after 6 months were 1.06 and 0.87, respectively. The mean postoperative astigmatism at 6 months was 0.19 D at an axis of 144 degrees. At 6 months, about three quarters (76.6%) of the eyes had a UCVA of 20/40 or better. One eye lost 2 lines of BSCVA. In 1 eye, the lens position had to be changed because of a large axis misalignment. No serious complications developed in any of the treated eyes during follow-up. CONCLUSIONS: Artisan toric pIOLs can correct moderate to high hyperopia combined with astigmatism with good refractive results. In this study, there were no serious complications. However, the predictability of the refractive results appeared to be lower than those in the correction of myopia and astigmatism with toric Artisan lenses.

Biometry of phakic intraocular lens using Scheimpflug photography.

PURPOSE: To examine lateral and axial positioning of phakic intraocular lenses (IOLs) with iris fixation in the anterior chamber and to examine short-term stability of the IOL position. SETTING: The Netherlands Opthalmic Research Institute, Amsterdam, the Netherlands. METHODS: Thirty patients participated in the study. Thirty-one eyes were implanted with the 204 type myopia IOL, 14 eyes with the 206 myopia IOL, and 8 eyes with the 203 hyperopia IOL. Scheimpflug slitlamp photographs were made through the optical axis along 4 meridians of the eyes. Ray tracing was used to obtain the lateral and axial position of the IOLs. RESULTS: Centration of the IOL with respect to the pupil's center and the tilt angle of the IOL with respect to the optical axis of the eye were measured. Standard deviation of decentration was 0.21 mm vertically and 0.16 mm horizontally. Standard deviation of tilt was 1.30 degrees vertically and 0.90 degrees horizontally. Tilt and decentration are proportional to each other. Vaulting, the distance between the crystalline lens and the IOL, was constant over a period of 24 months, ranging from 0.2 to 0.8 mm, depending primarily on the radius of curvature of the crystalline lens. A geometric model for this dependence was formulated. CONCLUSION: Phakic IOLs with iris fixation can be positioned in the eye with submillimeter precision. Axial position of iris-fixated phakic IOLs over time is excellent. Axial position and vaulting can be predicted when the radius of curvature of the crystalline lens is known. The IOL behaves as if mounted slightly above a sphere-the anterior surface of the crystalline lens.

Implantation of Artisan toric phakic intraocular lenses for the correction of astigmatism and spherical errors in patients with keratoconus.

PURPOSE: To evaluate the correction of astigmatism and spherical ametropia in patients with keratoconus through implantation of an Artisan toric phakic intraocular lens (PIOL) (Ophtec, Groningen, The Netherlands). METHODS: Artisan toric PIOLs were implanted uneventfully in both eyes of three patients with keratoconus with clear central corneas and contact lens intolerance. RESULTS: Best spectacle-corrected subjective visual acuity after lens implantation was unchanged in one eye and improved in five eyes. Spherical equivalent refraction was significantly reduced in all eyes (P=.03). The safety index was 1.49. CONCLUSIONS: The implantation of an Artisan toric PIOL may be an alternative for treating astigmatism and myopia in contact lens intolerant patients with keratoconus with clear central corneas. Especially in patients with associated myopia, this procedure is worth considering before planning a penetrating keratoplasty.

Toric phakic intraocular lens: European multicenter study.

OBJECTIVE: To evaluate safety, efficacy, predictability, stability, complications, and patient satisfaction after implantation of Artisan toric phakic intraocular lenses (TPIOLs) for the correction of myopia or hyperopia with astigmatism. DESIGN: Prospective, nonrandomized, comparative (self-controlled) multicenter trial. PARTICIPANTS: Seventy eyes of 53 patients (mean, 35 years; range, 22-59 years) with preoperative spherical equivalent between +6.50 and -21.25 diopters (D) and cylinder between 1.50 and 7.25 D. METHODS: Seventy eyes underwent implantation of a TPIOL with an optical zone of 5.0 mm (Artisan, Ophtec, Groningen, The Netherlands). The dioptric power of the intraocular lens was calculated by considering refraction, keratometry, and anterior chamber depth. The follow-up was 6 months in all cases. Lenses were available in powers ranging from +12.0 D to -23.5 D (spherical equivalent) in 0.5-D increments, with additional cylinder from 1.0 D to 7.0 D, also in 0.5-D increments. MAIN OUTCOME MEASURES: The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), refraction, endothelial cell count (ECC), intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, subjective complaints, and patient satisfaction. RESULTS: Eyes were divided into group A, myopia (n = 48), with an average preoperative spherical equivalent of -8.90 +/- 4.52 D, and group B, hyperopia (n = 22), with an average preoperative spherical equivalent of +3.25 +/- 1.98 D. No eyes in either group experienced a loss in BSCVA, and 46 eyes gained 1 or more lines of their preoperative BSCVA. In 62 eyes (88.6%), UCVA was 20/40 or better. There was a significant reduction in spherical errors and astigmatism in all cases after surgery. All eyes of both groups were within +/-1.00 D of target refraction, and 51 eyes (72.9%) were within +/-0.50 D of target refraction. There was a 4.5% mean total loss of ECC during the first 6 months. No serious complications were observed. Overall patient satisfaction was very high. CONCLUSIONS: Six-month clinical trial results demonstrate that implantation of the Artisan TPIOL safely, predictably, and effectively reduced or eliminated high ametropia and astigmatism with one procedure. The refractive effect was stable at 6 months after surgery.

Effect of ophthalmic viscosurgical devices on lens epithelial cells: a morphological study.

PURPOSE: To investigate the morphological effects of Viscoat (sodium hyaluronate 3.0%-chondroitin sulfate 4.0%) on lens epithelial cells (LECs). SETTING: Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, USA, and the Laboratory of Ultrastructural Morphology, Zoological Institute, University of Liège, Liège, Belgium. METHODS: Human LECs collected via capsulorhexis were examined by light microscopy (LM) and transmission electron microscopy (TEM). Lens epithelial cells from rabbit capsulorhexis samples were studied by LM and TEM following exposure to Provisc (sodium hyaluronate 1.0%) or Viscoat ophthalmic viscoelastic device (OVD). Since Viscoat is hypertonic (340 mOsm), hypertonic, isotonic, and hypotonic solutions were compared to investigate a possible mechanism for the observed effects. The effects of Provisc and Viscoat on rabbit LECs in the intact lens were also compared. RESULTS: Human LECs gathered via capsulorhexis following exposure to Viscoat were generally thinner than control samples and often had condensed nuclei and increased intracellular vacuolization. Rabbit capsular tissue exposed in situ to Viscoat demonstrated changes similar to those seen in humans. Cells exposed to Provisc were similar to cells in untreated controls in humans and rabbits. Corneal endothelial cells exposed to either agent were unaffected. Experiments with hypertonic and hypotonic buffers induced some of the changes noted with Viscoat, but the effects were less severe. Lens epithelial cells in intact rabbit lenses exposed to Viscoat appeared similar to LECs in the control samples. CONCLUSIONS: Light microscopy and TEM of human lens capsule tissue suggest that Viscoat induces significant morphological changes in LECs during cataract surgery. The changes may underlie the improved visualization of these cells that has been reported during cataract surgery. Corneal endothelial cells were unaffected by exposure to Viscoat. Studies in a rabbit model suggest that the hyperosmolarity of Viscoat may play a partial role in the LEC changes.

Trypan blue capsular staining to "find" the leading edge of a "lost" capsulorhexis.

PURPOSE: To describe an effective surgical technique to visualize an obscured leading edge of a capsulorhexis. DESIGN: Prospective, interventional case series. METHODS: In six eyes of six patients in which the capsulorhexis was started but could no longer be seen during surgery, the anterior chamber was irrigated to remove all viscoelastic, and 0.3-ml trypan blue 0.06% was applied onto the anterior lens capsule to stain and visualize the leading edge of the capsulorhexis. RESULTS: In all patients, the leading edge of the capsulorhexis was quickly visualized by using the dye. No adverse reactions were observed up to 1 year after surgery. CONCLUSION: Trypan blue staining of the anterior lens capsule is an effective and apparently safe technique to "find" a "lost" capsulorhexis during surgery.