Doi:10.1016/s0002-9394(03)00295-2

Artisan Toric Phakic Intraocular Lens for the JOSE L. GU
¨ ELL, MD, PHD, MERCEDES VA´ZQUEZ, MD, FRANCOISE MALECAZE, MD, PHD,
FELICIDAD MANERO, MD, OSCAR GRIS, MD, FORTINO VELASCO, MD,
HELENE HULIN, MD, AND JAUNE PUJOL, MD, PHD
● PURPOSE: To evaluate efficacy, predictability, and
Ophthalmol 2003;136:442– 447. 2003 by Elsevier
safety of Artisan toric phakic intraocular lens (Ophtec,
Inc. All rights reserved.)
Groningen, The Netherlands) implantation for the cor-
rection of astigmatism higher than 2 diopters.
● DESIGN: Interventional case series.
duced astigmatism has advanced rapidly in the last ● METHODS: This prospective study included 27 eyes of
decade. Astigmatic keratotomy, photorefractive as- 16 patients with a mean preoperative spherical equivalent
tigmatic keratectomy, laser-assisted in situ keratomileusis of –11.78 ؎ 6.24 diopters and a mean preoperative
(LASIK), photothermal keratoplasty techniques, cataract astigmatism of ؊3.43 ؎ 0.81. The Artisan phakic
or clear lens extraction surgery with toric intraocular lens intraocular lens was inserted in the anterior chamber
(IOL) implantation, phakic toric intraocular lenses, or a through a posterior corneal incision; the technique is
combination of these procedures are the main techniques similar to the implantation of the classical Artisan lens,
but in these cases it is particularly important to secure
The various procedures for the surgical management of the lens accurately in the correct axis. The main param-
high levels of astigmatism have had their limitations.
eters evaluated in this study were uncorrected visual
Combined procedures, such as astigmatic keratotomy plus acuity, best-corrected visual acuity, refraction, and en-
photorefractive astigmatic astigmatic kera- dothelial cell count.
● RESULTS: Twelve months after the implantation of the
keratotomy plus laser-assisted in situ and Artisan toric phakic intraocular lens, 62.90% of the eyes
astigmatic keratotomy with cataract and a proce- were within ؎0.50 diopters. of emmetropia and 96.20%
dure termed keratolenticuloplasty have been tried in these within ؎1.0 diopters. Seventy percent of the eyes gained
cases to improve efficacy and predictability.
1 or more Snellen lines from their preoperative best-
In young patients with high ametropia and high astig- corrected visual acuity, and 11.11% lost 1 Snellen line.
matism, toric phakic intraocular lenses may be an alterna- Mean endothelial cell count increased 2.9%. Mean of the
tive to be taken into account before other corneal parallel and orthogonal components of cylinder correc-
refractive approaches because of its theoretical advantages tion were 1.97 diopters and 0.10 diopters, respectively,
of reversibility and the preservation of the corneal contour.
of the intended cylinder change. The mean of axis
We have been working with the Artisan lens (Ophtec, alignment error was 10.53 degrees. No serious compli-
Gronigen, The Netherlands), an iris-claw fixated intraoc- cations were observed.
ular lens that is the phakic lens of our ● CONCLUSION: Artisan toric phakic intraocular lens
Currently we are using this type of lens to make toric implantation appears to be a safe and predictable method
corrections. Our inclusion and exclusion criteria are the for the correction of high levels of astigmatism.
same than for the standard Artisan lens.
Originally, the reasons to work with this intraocular lens (IOL) were its location of placement in the eye, far from Accepted for publication March 4, 2003.
the corneal endothelium and avoiding the posterior cham- From the IMO Instituto de Microcirugı´a Ocular, Barcelona, Spain ber, and its larger optical zone compared with other (J.L.G., M.V., O.G., F.V.); Service Ophtalmologie, CHU Toulouse, anterior chamber phakic IOLs used for the same range of Toulouse, France (F.M., H.H.); Centre de Desenvolupament de Sensors,Instrumentacio i Sistemas (CD6), Universitat Politecnica de Catalunya, corrections. An important optical advantage is that, be- cause of its fixation characteristics, centering the lens over Inquires to Jose´ L. Gu¨ell, MD, PhD, Instituto de Microcirugı´a Ocular the pupil is dependent on surgeon ability rather than angle (IMO), 08022, Barcelona, Spain; fax: (ϩ34) 93-4171301; e-mail:[email protected] situation (as with angle-supported IOLs) or difficult “white 2003 BY ELSEVIER INC. ALL RIGHTS RESERVED.
to white” measurements (as with posterior chamber IOLs).
complete ophthalmologic examination was performed at We report the results of 27 eyes implanted with the each visit, as previously described, with the exception of Artisan toric phakic IOLs designed to correct both spher- the first and seventh day postoperatively, on which endo- ical and astigmatic components of ametropia.
thelial cell count was not measured.
The Artisan IOL is a one-piece polymethylmetacrylate (PMMA) lens. Its overall diameter is 8.5 mm, maximum height is 1.04 mm, and optical zone diameter is 5.0 mm.
The available powers for myopia vary from –3.00 to –20.00 THE STUDY DESIGN IS AN INTERVENTIONAL CASE SERIES.
D, with cylindrical correction from 1 to 7 D and, for Two surgeons, Jose´ L. Gu¨ell at Instituto de Microcirugı´a hyperopia, from ϩ 2.00 to ϩ 12.00 D with the same Ocular de Barcelona, Spain, and F. Malecaze at Service cylindrical correction as for myopia.
Ophthalmologie, CHU Toulouse, France, performed the The dioptric power of the lens was calculated with the procedures. We enrolled 27 eyes of 16 patients in this patient’s refractive error, the anterior chamber depth, and prospective study (6 men, 10 women), aged from 28 to 50 There are two available models for correcting, with a The preoperative spherical equivalent ranged from similar surgical technique, any astigmatic axis: a toric ϩ6.00 diopters (D) to –19.50 diopters (D) (mean, –11.78 Artisan phakic IOL with a cylinder axis at 0 degrees Ϯ 6.24) and preoperative astigmatism ranged from Ϫ2.25 (model A) and a toric Artisan phakic IOL with a cylinder to Ϫ4.75 (mean, –3.43 Ϯ 0.90). Preoperative uncorrected axis at 90 degrees (model B) with respect to the position of visual acuity was lower than 20/400 in all of the eyes, and the haptics. When the axis of the cylinder is between 0 preoperative best-corrected visual acuity was Ն20/40 in and 45 degrees or 135 and 180 degrees, model A is recommended; when the axis of the cylinder is between 45 The study included a consecutive series of patients who, and 135 degrees, model B is recommended.
for medical, professional, or personal requirements, at- The procedure was similar to standard Artisan IOL tained unsatisfactory correction with spectacles or contact implantation, but in these cases it was important to secure lenses; had a stable refraction for at least 1 year; had the lens accurately in the correct axis to avoid induced astigmatism Ͼ Ϫ2.00; and either did not want refractive astigmatism. The enclavation sites were preoperatively surgery or it was contraindicated for them. The study was marked on the iris using argon laser. The limbus was also approved by the ethical committees of Barcelona (Au- marked, immediately before the surgery, while the patient tonoma University) and Toulouse. All patients were fully was sitting upright at the ophthalmometer.
informed of the details and possible risks of the procedure We generally used a superior approach and retrobulbar in accordance with the Helsinki Declaration, and written anesthesia (4 cc of a proportional combination of mepiva- informed consent was obtained for each patient.
Exclusion criteria were as follows: anterior segment caine 2% and bupivacaine 0.75%). The first plane of a pathology, inadequate eyelid closure, uveitis, previous 5.2-mm-long posterior vascular corneal incision and two corneal or intraocular surgery, monocular status, systemic vertical paracentesis were performed. These last two were diseases (such as autoimmune, connective tissue disease, located for an easy iris enclavation, accordingly, to the atopia, or diabetes), chronic treatment with corticosteroids cylinder axis where the IOL had to be placed. After the or any immunosuppressive treatment or state, pregnancy, intracameral injection of acetylcholine and viscoelastic endothelial cell counts of less than 2,200 cell/mm2, and an material through the paracentesis, the second plane of the anterior chamber central depth less than 3.2 mm.
incision was performed, opening the anterior chamber.
Examinations were performed by M. Vazquez and H.
The lens was then completely introduced in one step to Hulin. The preoperative evaluation included uncorrected avoid any contact of the front part of the IOL with the visual acuity and best-corrected visual acuity, manifest and crystalline lens. Under viscoelastic protection, the IOL was cycloplegic refraction, slit-lamp microscope examination, then rotated until the appropriate axis was reached. The applanation tonometry, keratometry, and indirect oph- IOL was fixated with a blunt 30-G blended needle, thalmoscopy. The subjective response for satisfaction was grasping, through both paracentesis, the iris into both rated on a scale from 1 to 5 (1 ϭ very poor, 2 ϭ poor, 3 ϭ “claws.” Once the proper axis alignment and centering moderate, 4 ϭ good, and 5 ϭ excellent). The symptoms such over the pupil was confirmed, a peripheral slit iridotomy at as glare and halos were rated as 1 ϭ very intense, 2 ϭ 12 o’clock was performed. Viscoelastic material was ex- intense, 3 ϭ moderate, 4 ϭ few, and 5 ϭ none. Comple- changed with balanced salt solution through our irrigation- mentary examinations were also required, including axial aspiration automatic system, and the incision was closed length and anterior chamber depth, videokeratography, with five interrupted 10-0 nylon sutures. The correct tension and distribution of the sutures were confirmed with Postoperative evaluations were programmed at 24 hours, a Maloney qualitative keratometer. Postoperative treat- 1 week, and 1, 3, 6, and 12 months after surgery. A ment included tobramycin and dexamethasone four times per day and timolol 0.5% twice a day for 3 weeks. Sutureremoval was started at the first postoperative month,taking into account postoperative refractive and topo-graphic astigmatism.
Change in spherical equivalent manifest refraction was where DSE is change in spherical equivalent, SE and SE are spherical equivalent at preoperative and postoperativeexamination, respectively.
Cylindrical refractions were represented as double-angle FIGURE 1. Scattergram shows the preoperative manifiest
spherical equivalent refraction vs the induced change 1 year
vectors, which can be decomposed into two perpendicular after Artisan toric phakic intraocular lens implantation.
components in rectangular coordinates as follows: Ͼ 90, then g ϭ b Ϫ b Ͻ Ϫ90, then g ϭ b Ϫ b otherwise, g ϭ b Ϫ b ϭ axis of intended cylinder change.
Where X is the cardinal component, Y ϭ is the oblique A positive g indicates a counterclockwise (CCW) axis component, A is the cylinder magnitude in diopters, a ϭ deviation and a negative g indicates a clockwise (CW) axis Cylinder axis in degree. X is positive for against-the-rule deviation. By our convention, the axis of intended cylinder astigmatism and negative for with-the-rule astigmatism. Y correction was always the same, from the consensus pre- is positive for a positive cylinder at 45 and negative for a positive cylinder at 135. The positive cylinder convention The cylinder changes can be decomposed into two rectangular components referenced to the axis of intended Changes in cylindrical refractions are computed in where DP is the component of cylinder change parallel to where DX is the change in cardinal component of astig- the axis of intended correction and DO is the component matism, X is the postoperative cardinal components, X of cylinder change orthogonal to the axis of intended the preoperative cardinal components, DY the change in correction. The terms parallel and orthogonal refer to oblique component of astigmatism, Y the postoperative orientations in the double-angle vector plot.
The formulae for the decomposition of astigmatism vectors into cardinal and oblique components are adapted Conversion from rectangular to polar coordinates is Concerning quantitative data, the comparisons between pre- and postoperative periods were performed using the DA ϭ ͑DX2 ϩ DY2͒1/2 Student t test for paired data. Comparisons for percentages If DX ϭ 0, then if DY Ͼ 0, b ϭ 45, otherwise b ϭ 135.
were performed using the ␹2 and McNemar tests.
If DX Ͼ 0 and DY Ͼ 0, b ϭ 0.5 arctan (DY/DX);if DX Ͼ 0 and DY Ͻ 0, b ϭ 0.5 {arctan(DY/DX) ϩ 360}; if DX Ͻ 0, b ϭ 0.5 {arctan(DY/DX) ϩ 180}, MEAN PREOPERATIVE SPHERICAL EQUIVALENT REFRAC- where DA is the magnitude of cylinder change, and b is the tion and astigmatism were –11.78 Ϯ 6.24 (ϩ 6.00 to –19.50) and –3.48 Ϯ 0.81 (Ϫ2.25 to Ϫ4.50), respectively.
Deviation g of the axis of the actual cylinder change Mean postoperative spherical equivalent refraction and from the axis of intended change is computed as follows: astigmatism were – 0.58 Ϯ 0.64 (Ϫ1.25 to 0) and – 0.66 Ϯ FIGURE 2. The bar graph depicts the change in best-corrected visual acuity from preoperative to the 1-year postoperative
examinations in terms of change in the number of Snellen lines.
0.57 (Ϫ1.00 to 0), respectively, at 12 months after the surgery. A satisfactory residual peared early, at the first month, and an refraction had already been obtained as early One year after the surgery, 96.20% of the within Ϯ1.00 D of emmetropia, and 17 eyes ing the astigmatism, 85.50% of the eyes were D after IOL implantation and 8 eyes (30%) (P ϭ .21). There were no significant tude of cylindrical power error was 0.74 D, constructed a formal statistical analysis of the null hypoth- pigmentary dispersion, pupillary block, or retinal complica- esis in which postsurgical power vectors were equal to zero.
tions occurred during the follow-up period The results of these tests, conducted at the 0.01 level, All the patients were highly satisfied with the procedure.
indicated that neither astigmatism components are signif- Mean subjective response for satisfaction and symptoms such as glare and halos was 4.0 at 12 months after the Preoperative uncorrected visual acuity was less than 20/400 surgery, using the scale described previously.
in all cases; its evolution during the first postoperative year isshown in At 1 year, about two thirds (63%) of theeyes had an uncorrected visual acuity of 20/40 or better. The maximal efficacy was observed as soon as the third month(Table 1), once the sutures had been removed.
THE CORRECTION OF HIGH ASTIGMATISM IS STILL A CON- With regard to best-corrected visual acuity, as shown in troversial issue. Corneal refractive (nonreversible) surgery the safety index (ratio of mean postoperative cannot adequately correct high myopia and astigmatism TABLE 1. Comparison of the Visual Acuity and Refractive Outcomes at Various Intervals
After Artisan Toric Phakic Intraocular Lens Implantation UCVA ϭ Uncorrected visual acuity; BCVA ϭ best-corrected visual acuity; D ϭ diopters.
*Safety index ϭ ratio of mean postoperative BCVA over mean preoperative BCVA.
TABLE 2. Statistical Summary of the Decomposition of
TABLE 4. Postsurgical Axis Error
Astigmatism Vectors Into Parallel and Orthogonal DP ϭ component of cylinder change parallel to the axis of intended correction; DO ϭ component of cylinder change or- Artisan implantation. The central effective optical zone thogonal to the axis of intended correction.
will always be smaller in the first two procedures, and thuspatients may suffer more frequently from complains such asglare and halos, especially in dim lighting TABLE 3. Statistical Summary of the Magnitude of
Therefore, correction with a toric lens may be an interest- ing alternative, even though this means correcting acorneal astigmatism that theoretically could be treated by The refractive results of this study were excellent. At 1 year, 96% (25 eyes) of the eyes were within Ϯ1.00 D of emmetropia and 63% (17 eyes) were within Ϯ0.50 D.
These refractive results appeared early in the postoperative SD ϭ standard deviation; SEM ϭ standard error of the mean.
period; similar values had already been attained as early asthe third month. With corneal refractive surgery it has notalways been possible to attain such results and combined levels without decreasing the central optical zone and thus procedures or upgraded profiles or techniques had to be limiting the quality of Combined procedures employed to improve effiIn contrast, all patients in such as astigmatic keratotomy plus and better and our study noted that they were highly satisfied with the improved ablational profiles and techniques (positive cyl- inder, cross cylinder) have emerged to achieve the latter.
Seventy percent of the eyes in this study gained one or With the implantation of the Artisan toric phakic IOL, more lines of their preoperative best-corrected visual however, it is theoretically possible to obtain good results acuity. Other have reported this gain in visual acuity after phakic IOL implantation because of the Artisan toric phakic IOL implantation allows correction increase in the size of the retinal image.
of myopia up to Ϫ20.00 and of astigmatism up to 7.00 D, Damage to the endothelium is one of the main concerns with an optical zone of 5 mm. Conversely, it is a reversible with anterior chamber phakic IOL implantation. This and adjustable procedure, hence the lens may be ex- could be the result of the surgery itself or of the presence planted, exchanged, or adjusted with corneal refractive of a foreign body in the anterior chamber (chronic inflam- surgery, primarily LASIK. Another advantage of this matory or mechanical hypothesis). Nevertheless, we ob- technique is the possibility of attaining better vision served a paradoxical increase (ϩ2.90%) in the mean because the original corneal contour is preserved. Perform- endothelial cell count. This may be due to the reproduc- ing a 6-mm optical zone arcuate keratotomy or 5-mm ibility of the technique, despite the fact that we took optical zone LASIK is different from a 5-mm optical zone extreme care to eliminate bias (eight measures at each exploration time per patient). It may also be explained by 3. Guell JL, Vazquez M. Correction of high astigmatism with the long-term daily use by most of our patients of toric soft astigmatic keratotomy combined with laser in situ kerato- contact lenses or rigid gas permeable contact lenses until mileusis. J Cataract Refract Surg 2000;26:960 –966.
4. Kershner RM. Keratolenticuloplasty: arcuate keratotomy for the surgery was performed (13 of 16 patients). Despite this, cataract surgery and astigmatism. J Cataract Refract Surg a long-term follow-up is essential with any type of anterior chamber lenses to assess the stability of endothelial cell 5. Gu¨ell JL, Vazquez M, Gris O, De Muller A, Manero F.
count and morphology. Budo and reported an Combined surgery to correct high myopia: iris claw phakic endothelial cell loss of 0.7% per year between 2 and 3 years intraocular lens and laser in situ keratomileusis. J Refract following a mean loss of 7.1% during the first year, possibly 6. Gu¨ell JL, Vazquez M. Adjustable refractive surgery: 6-mm associated with the initial surgical trauma. Similar results Artisan lens plus laser in situ keratomileusis for the correc- have been described by other authors, including A tion of high myopia. Ophthalmology 2001;108:945–952.
more complete follow-up of these patients (5 to 10 years) 7. Van der Heijde GL, Fechner PU, Worst JGF. Optische compared with an age-matched control group would be Konsequenzen del Implantation einer negativen Intraokular- important in assessing the safety of these lenses and linse bei myopen Patienten. Klin Monatsbl Augenheilkd considering their use as an standard either in myopia alone 8. Holladay JT, Dudeja DR, Koch DD. Evaluating and report- ing astigmatism for individual and aggregate data. J Cataract We had no intraoperative or postoperative complica- tions. This is probably related to our experience with this 9. Thibos LN, Wheeler W, Horner D. Power vectors: an type of implant. We must point out that, from our point of application of Fourier analysis to the description and statis- view, a proper surgical training is especially important with tical analysis of refractive error. Optom Vis Sci 1997;74:367– this type of IOL implantation and especially with the toric 10. Naeser K, Beherens JK, Naeser EV. Quantitative assessment model. In our study group, best-corrected visual acuity was of corneal astigmatic surgery: Expanding the polar values equal or better compared with the preoperative values, concept. J Cataract Refract Surg 1994;20:162–168.
which favors the procedure; only three cases lost 1 Snellen 11. Alpins NA. Vector analysis of astigmatism changes by line with respect to their best-corrected visual acuity. As flattening, steepening and torque. J Cataract Refract Surg with other no postoperative glaucoma has been observed, with the exception of a mild, transient early 12. Huang D, Stulting D, Carr J, et al. Multiple regression and vector analyses of laser in situ keratomileusis for myopia and episode of elevated intraocular pressure. The problem astigmatism. J Refract Surg 1999;15:538 –550.
resolved with discontinuation of topical corticosteroids.
13. Chv´ez S, Chayet A, Celikkol L, Parker J, Celikkol G, Other complications reported in the literature, such as Feldman ST. Analysis of astigmatism keratotomy with a 5.0 mm optical clear zone. Am J Ophthalmol 1996;121:65–76.
14. Danjoux JP, Fraenkel G, Lawless MA, Rogers C. Treatment of myopic astigmatism with the Summit Apex Plus excimer Artisan toric phakic IOL implantation appears to be a laser. J Cataract Surg 1997;23:1472–1479.
15. Uozato H, Guyton DL. Centering corneal surgical proce- suitable option for patients with high levels of myopia or dures. Am J Ophthalmol 1987;103:264 –275.
hyperopia and astigmatism and who otherwise have nor- 16. Pe´rez-Santonja JJ, Bueno J, Zato MA. Surgical correction of mal ophthalmologic examinations. Nevertheless a long- high myopia in phakic eyes with Worst-Fechner myopia term follow-up of these patients will provide the last word.
intraocular lenses. J Refract Surg 1997;13:268 –284.
This technique has been helpful to us in the correction of 17. Fechner PU, Wichmann W. Correction of myopia by im- postpenetrating keratoplasty ammetropia. In any case, we plantation of minus optic (Worst iris claw) lenses into theanterior chamber of phakic eyes. Eur J Implant Surg 1993;5: favor this approach over aggressive irreversible corneal surgery, combined or alone, in correcting this high 18. Budo C, Hessloehl JC, Izak M, et al. Multicenter study of the ametropic group. From our point of view, corneal refractive Artisan phakic intraocular lens. J Cataract Refract Surg surgery, customized or not, should be reserved for postop- erative refinements until the IOL itself can be modified in 19. Menezo JL, Cisneros AL, Rodriguez-Salvador V. Endothelial situ (Light Adjustable IOL project).
study of iris-claw phakic lens: four year follow-up. J CataractRefract Surg 1998;8:1039 –1049.
20. Krumeich JH, Daniel J, Gas R. Closed-system technique for implantation of iris-supported negative-power intraocular lens. J Refract Surg 1996;12:334 –340.
21. Fechner PU, Strobel J, Wicchmann W. Correction of myo- 1. Ganem S, Sidhoum B. Surgery in myopic astigmatism: pia by implantation of a concave Worst-iris claw lens into arciform keratotomy and PRK versus PARK. Bull Soc Belge phakic eyes. Refract Corneal Surg 1991;7:286 –298.
22. Pe´rez-Santonja JJ, Bueno JL, Meza J, et al. Ischemic optic 2. Manche EE, Maloney RK. Astigmatism keratotomy com- neuropathy after intraocular lens implantation to correct bined with myopic keratomileusis in situ for compound high myopia in a phakic patient. J Cataract Refract Surg myopic astigmatism. Am J Ophthalmol 1996;122:18 –28.

Source: http://www.leeeye.kr/popup/non/Toricartisan1.pdf