Camille Budo

Multicenter study of the Artisan phakic intraocular lens.

PURPOSE To assess the Artisan intraocular lens to correct myopia in phakic eyes. SETTING European multicenter study sponsored by Ophtec BV, Groningen, The Netherlands. METHODS In this prospective multicenter clinical study, the Artisan lens was implanted in 518 eyes between September 1991 and October 1999. The power of the lenses ranged from -5.0 to -20.0 diopters (D). Follow-up examinations were performed at 6 months and 1, 2, and 3 years. Follow-up ranged from 6 months (n = 454) to 3 years (n = 249). The preoperative uncorrected visual acuity (UCVA) was not recorded but was estimated to be worse than 0.1. The preoperative mean best spectacle-corrected visual acuity (BSCVA) was 0.67 +/- 0.26 (SD). Endothelial cell counts were done at 6 months and 1, 2, and 3 years in a subgroup of 129 eyes. RESULTS A UCVA of 20/40 or better was observed in 76.8% of eyes regardless of the postoperative goal. A BSCVA of 20/40 or better was observed in 93.9% of eyes and remained stable throughout the follow-up. Of the eyes with extremely high myopia (>-15.0 D), 63.3% gained 2 or more lines of BSCVA; of those with moderate myopia (-5.0 to -10.0 D), 23.5% gained 2 or more lines. The mean endothelial cell density change was 4.8% at 6 months, 2.4% at 1 year, 1.7% at 2 years, and 0.7% at 3 years. The incidence of persistent adverse events at 3 years was relatively low. Secondary surgical interventions included repositioning of the lens because of poor initial placement and lens exchange because of preoperative power calculation errors. Glare and halo effects during night driving were noted and were related to large pupils in young patients. CONCLUSION The Artisan lens is a safe, stable, efficacious, and predictable method to correct -5.0 to -20.0 D of myopia. This study suggests that the corneal endothelial cell loss is stabilized to the physiologically normal level after 3 years.

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.

Two-year postoperative results of Galand lens implantation

ABSTRACT The Galand lens is a closed J‐loop implant for capsular‐bag fixation. We present a retrospective study of 214 eyes implanted with this lens. Eyes were examined at three months, six months, one year, and two years after surgery. Results indicate that 82.2% of eyes obtained a visual acuity of 20/40 or better at two years after implantation. If patients with other ocular pathology were excluded, the percentage of those whose visual acuity was 20/40 or better at two years was 93.7%. Although this implant avoids “spring action” within the capsular bag, the rate of dislocation into the posterior chamber was low (0.93% in this series). Early stability, before sealing of the capsular leaflets, was obtained by limiting the anterior capsulectomy to the pupillary area. No late zonular rupture was observed. Secondary posterior capsulotomy has been performed in 9.8% of the 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.

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.

Cytokeratin in lens epithelial cells and its effect on anterior lens capsule opacification

ABSTRACT Postoperative lens capsule opacification is a complication of extracapsular cataract extraction. To avoid this problem, we aspirated the epithelial cells lining the internal surface of the capsular bag. Anterior capsule specimens collected three and six years after the first surgical intervention (extracapsular cataract extraction with intercapsular implantation of a poly[methyl methacrylate] intraocular lens) and in vitro studies of epithelial cell cultures revealed the presence of intracellular and extracellular cytokeratin. After several years, the cytokeratin layers were arranged in a pattern analogous to that of liquid crystalline phases and many nonhuman extraocular tissues.

Early results with the 8 mm and 9 mm HEMA disc intraocular lens

ABSTRACT This study presents our experience with 34 HEMA disc intraocular lenses implanted in the capsular bag. Despite the small number of cases and the relatively short mean postoperative follow‐up of nine months, the results show a low incidence of uveitis and capsular fibrosis and excellent biocompatibility. The following complications were observed: four luxations of the 8 mm lens and one of the 9 mm lens in the anterior chamber. A visual acuity of 20/20 to 20/40 was obtained in 32 patients (94%).

Another view of iris-claw IOL implantation

Hydroimplantation Tak describes the use of an irrigation cannula in conjunction with continuous irrigation mode during foldable intraocular lens (IOL) implantation as opposed to the usual technique of IOL implantation into an ophthalmic viscosurgical device (OVD)–filled chamber. Although the youthful ophthalmologists among us (and I presume that both the author and the reviewer of the article fall into that desirable category) may have no knowledge of this, the use of either continuous or on-demand (under foot pedal control) infusion during IOL implantation was practiced by many of us in many thousands of eyes between approximately 1980 and the advent of OVDs. I personally used the chamber maintainer technique that originated with Thrasher in at least 5000 eyes. There is no way that the hydro technique is as forgiving as the standard method, and I would certainly caution against the use of continuous infusion because iris prolapse can be easily induced if this method is used. Intermittent depression of a foot pedal to deliver infusion as necessary is far more desirable in my opinion. However, I am certain that the OVD method is here to stay (and I have no financial interest in such products). Richard J. Mackool, MD Astoria, New York, USA

Metaanalysis of cataract after phakic intraocular lens surgery

REPLY: Gatinel has opened an interesting discussion about the validity and accuracy of measuring wavefront aberration in patients with diffractive IOLs, given that the aberrometer may wrongly reconstruct the wavefront of an eye implanted with an IOL. To test the capability of wavefront sensors in the optical analysis of eyes implanted with different IOL types, wemay first look at the sensor’s ability to obtain a measurement and then at how accurately this corresponds to the clinical refraction of the eye. In our study, the ocular aberrations were measured with the Complete Ophthalmic Analysis System (COAS), a high-resolution Hartmann-Shack aberrometer. This aberrometer has a spatial resolution of 210 mm, analyzing a total of 872 samples for a pupil up to 7.0 mm. For each eye, measurements were repeated at least 3 times to obtain awell-focused, properly aligned image of the eye. If the device had had problems during detection of the centroids, as Gatinel suggests, the measurement would have been impossible to obtain as valid, as occurs in highly myopic eyes or eyes affected by high levels of corneal aberrations, as in keratoconus. This was not the case in any of our clinical studies in which a proper measurement was always obtained. Our data on clinical refraction of the patients always corresponded well and accurately to the refraction obtained by the COAS aberrometric study (patient 2, right eye [ReSTOR group]: subjective refraction 0.25 0.25 120 versus wavefront refraction 0.19 0.26 135). This was not the case in a recent report inwhich the disparity between the clinical refraction and the aberrometry refraction with refractive multifocal IOLs was large, indicating the lack of accuracy of global wavefront technology in such IOLs. On the other hand, we think the absolute values might be questioned but not the relative ones used for comparison between different IOLs, for which the error should be the same in all cases (standard error). Regarding the double-pass techniques, we agree that they may be adequate to evaluate the actual PSF and MTF in patients with IOLs. However, this device evaluates the global eye’s optical quality, which is affected by the corneal aberrations of the individual eye. When the MTF of a patient implanted with a multifocal IOL ismeasured, we obtain themeasurement as global but also ignore the focus of the measurement: near, distance, or intermediate. In summary, our report and Gatinel’s letter highlight an important issuedthe need for isolated optical measurements of IOLs when implanted inside the eye, a condition different from those of IOL measurements at the optical bench. Such information is critical today when data on IOLs of innovative design inside the eye may lead to important decisions about which IOLs are better or perform more successfully when implanted in the human eye.dDolores Ortiz, PhD, Jorge L. Alió, MD, PhD