Multicenter study of the Artisan phakic intraocular lens

183 Pages·2011·8.07 MB·English

Articles of Interest
ARTISAN® & ARTIFLEX® Phakic IOL
January, 2012
Articles of Interest Content
ARTISAN® & ARTIFLEX® Phakic IOL
ARTISAN®
Tahzib NG, Nuijts RM, Wu WY, Budo CJ
Long-term Study of Artisan Phakic Intraocular Lens Implantation for the Correction of Moderate to High Myopia Ten-Year Follow-up Results
Ophthalmology 114(6):1133-42; 2007
Tahzib NG, Bootsma SJ, Eggink FA, Nuijts RM
Functional outcome and patient satisfaction after artisan phakic intraocular lens implantation for the correction of myopia
American J of Ophthalmology 142(1): 31-39; 2006
Camille Budo, Jean C. Hessloehl, Milan Izak, Gregorius P. Luyten, Jose L. Menezo, Bozkurt A. Sener, Marie José Tassignon, Herve Termote,
Jan G.F. Worst
Multicenter study of the Artisan phakic intraocular lens
J Cataract Refract Surgery 26:1163-71; 2000
ARTISAN® Myopia Small
Naoko Asano-Kato, MD, PhD, Ikuko Toda, MD, PhD, Yoshiko Hori-Komai, MD, PhD, Chikako Sakai, Teruki Fukumoto, MD, Hiroyuki Arai,
MD, PhD, Murat Dogru, MD, PhD, Yoji Takano, MD, Kazuo Tsubota, MD, PhD
Experience with the Artisan phakic intraocular lens in Asian eyes
J Cataract Refract Surgery 31: 910-915; 2005
ARTISAN® Toric
Mana Tehrani, MD, H. Burkhard Dick, MD
Iris-fixated toric phakic intraocular lens: Three year follow-up
J Cataract Refract Surg 32: 1301-1306;2006
Dick HB, Alio J, Bianchetti M, Budo C, Christiaans BJ, El-Danasoury MA, Guell JL, Krumeich J, Landesz M, Loureiro F, Luyten GP, Marinho A,
Rahhal MS, Schwenn O, Spirig R, Thomann U, Venter J
Toric phakic intraocular lens: European multicenter study
Ophthalmology 110(1): 150-62; 2003
ARTISAN® Myopia / Hyperopia / Toric
Güell JL, Morral M, Gris O, Gaytan J, Sisquella M, Manero F
Five-Year Follow-up of 399 Phakic Artisan-Verisyse Implantation for Myopia, Hyperopia, and/or Astigmatism.
Ophthalmology; 115(6):1002-12; 2008
Bartels MC, Santana NT, Budo C, van Rij G, Mulder PG, Luyten GP
Toric phakic intraocular lens for the correction of hyperopia and astigmatism
J Cataract Refract Surgery 32(2): 243-9 2006
ARTIFLEX®
Lucien A.M. van Philips
Higher-order aberrations after iris-fixated foldable phakic intraocular lens implantation and wavefront-guided photorefractive keratectomy
for the correction of myopia
J Cataract Refract Surgery. 37:284–294 2011
Dick HB, Budo C, Malecaze F, Güell JL, Marinho AA, Nuijts RM, Luyten GP, Menezo JL, Kohnen T
Foldable Artiflex phakic intraocular lens for the correction of myopia: two-year follow-up results of a prospective European multicenter study.
Ophthalmology 116(4):671-7 2009
Coullet J, Güell JL, Fournié P, Grandjean H, Gaytan J, Arné JL, Malecaze F
Iris-supported Phakic Lenses (Rigid vs Foldable Version) for Treating Moderately High Myopia: Randomized Paired Eye Comparison
American J of Ophthalmology 142(6):909-18; 2006
Articles of Interest Content
ARTISAN® & ARTIFLEX® Phakic IOL
ECC
Dick HB, Marinho AAP, Guëll JL, Budo C
White Paper to address recent regulatory activity in Europe related to restricting sales of Anterior Chamber Phakic IOLs.
Doors M, Cals DWJK, Berendschot TTJM, De Brabander J, Hendrikse F, Webers CAB, Nuijts RMMA
Influence of anterior chamber morphometrics on endotherlial cell changes after phakic intraocular lens implantation
J Cataract Refract Surgery. 34; 2110-2118 2008
Benedetti S, Casamenti V, Benedetti M
Long-term endothelial changes in phakic eyes after Artisan intraocular lens implantation to correct myopia Five-year study
J Cataract Refract Surgery May;33(5):784-90; 2007
Mihai Pop, MD, Yves Payette, MSc
Initial Results of Endothelial Cell Counts after Artisan Lens for Phakic Eyes, an evaluation of the United States Food and Drug
Administration Ophtec study
Ophthalmology 111(2):309-17; 2004
Anterior segment imaging
Doors M, Berendschot TT, Hendrikse F, Webers CA, Nuijts RM
Value of preoperative phakic intraocular lens simulation using optical coherence tomography
J Cataract Refract Surgery. 35(3):438-43 2009
Tehrani M, Schaefer M, Koeppe J, Dick HB.
Preoperative simulation of postoperative iris-fixated phakic intraocular lens position and simulation of aging using high-resolution
Scheimpflug imaging
J Cataract Refract Surgery 33(1):11-4; 2007
Special indications / case reports
Cornea Pathologies
Luis Izquierdo, Jr, MD, MMed; Maria A. Henriquez, MD; Martin McCarthy, MD
Artiflex Phakic Intraocular Lens Implantation After Corneal Collagen Cross-linking in Keratoconic Eyes
J Refract Surg. Jan 3:1-6 2011
Budo C, Bartels MC, van Rij G
Implantation of Artisan phakic toric intraocular lenses for the correction of astigmatism and spherical errors in patients with keratoconus
J Refract Surg. 21(3): 218-22; 2005
Nuijts RM, Abhilak Missier KA, Nabar VA, Japing WJ
Artisan toric lens implantation for correction of postkeratoplasty astigmatism.
Ophthalmology 111(6): 1086-94; 2004
Pediatric
Jorge L. Alió, MD, PhD; Bader T. Toffaha, MD; Carlos Laria, MD, PhD; David P. Piñero, PhD
Phakic Intraocular Lens Implantation for Treatment of Anisometropia and Amblyopia in Children: 5-year Follow-up
J Refract Surg. Feb 1:1-8 2011
Pirouzian A, Ip KC
Anterior chamber phakic intraocular lens implantation in children to treat severe anisometropic myopia and amblyopia: 3-year clinical results
J Cataract Refract Surgery. Sep;36(9):1486-93 2010
Artisan Aphakia
Iris-claw intraocular lenses to correct aphakia in the absence of capsule support. Samantha R. De Silva, MRCOphth, Kikkeri Arun,
FRCS, Maghizh Anandan, FRCOphth, Nicholas Glover, FRCOphth, Chetan K. Patel, FRCOphth, Paul Rosen, FRCOphth.
J Cataract Refract Surg 2011; 37:1667–1672
Long-term Study of Artisan Phakic
Intraocular Lens Implantation for the
Correction of Moderate to High Myopia
Ten-Year Follow-up Results
Nayyirih G. Tahzib, MD,1 Rudy M. Nuijts, MD, PhD,1 Wendy Y. Wu, MD,1 Camille J. Budo, MD2
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-nineeyesof49patientswhounderwentArtisanPIOLimplantationforthecorrectionof
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 (cid:1)0.70(cid:2)1.00 diopters (D; range, (cid:1)4.00 to
2.00D),withnosignificantchangeinmeanSEbetween1,6,and10years.At10years,68.8%ofalleyeswere
within1.0Doftheintendedcorrection.At10years,31.2%(n(cid:3)24)gained1ormoreSnellenlinesofBCVAand
2.6% (n (cid:3) 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(cid:2)3.5 mmHg
(range, 7–25 mmHg) at 10 years. The mean endothelial cell loss was (cid:1)8.86(cid:2)16.01% (range, (cid:1)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.
Ophthalmology 2007;114:1133–1142 © 2007 by the American Academy of Ophthalmology.
To be able to evaluate the results of any corneal refractive evaluating surgical results of PIOL implantations, the as-
surgical technique, it is essential to monitor the long-term sessment of corneal endothelial cell loss over time is an
refractive stability, refractive predictability, safety, and ef- additional important factor in determining the long-term
ficacy of that particular procedure. Several published clini- safety.
cal reports have demonstrated the excellent short-term per- The long-term accuracy of excimer laser refractive sur-
formance of the Artisan phakic intraocular lens (PIOL) geryisknowntodeclinewithhigherlevelsofmyopia.11–13
(Ophtec B.V., Groningen, The Netherlands).1–10 When Additionally, secondary effects such as glare and halos are
common downsides after excimer laser treatment for mod-
erate to high myopia, because more corneal tissue is re-
Originallyreceived:January4,2006.
Accepted:September15,2006. Manuscriptno.2006-28. moved and the optical zone needs to be smaller to prevent
1Department of Ophthalmology, Academic Hospital Maastricht, Maas- excessively deep ablations.14–16 The surgical implantation
tricht,TheNetherlands. ofPIOLsoffersadvantagesinthecorrectionofhighmyopia
2Sint-Truiden,Belgium. in that they provide the best chance of maintaining the
Presentedat:CongressoftheAmericanSocietyforCataractandRefractive best-corrected visual acuity (BCVA).3,17 Specific concerns
Surgery,April2005,Washington,DC. related to the implantation of PIOLs are the safety of the
Dr Budo is a medical monitor and consultant to Ophtec BV. No other surgicalprocedureforthecornealendothelium,thestability
authorhasafinancialorproprietaryinterestintheproductsmentionedin
oftherefractiveresults,andthelong-termbiocompatibility
thearticle.
with the ocular tissue.7,10
CorrespondencetoNayyirihG.Tahzib,MD,DepartmentofOphthalmol-
Implantations of PIOLs have been at the center of sci-
ogy, Academic Hospital Maastricht, P. Debyelaan 25, 6202 AZ, Maas-
tricht,TheNetherlands.E-mail:[email protected]. entific interest for the surgical correction of moderate to
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©2007bytheAmericanAcademyofOphthalmology ISSN0161-6420/07/$–seefrontmatter
PublishedbyElsevierInc. doi:10.1016/j.ophtha.2006.09.029
Ophthalmology Volume 114, Number 6, June 2007
high myopia, for example, in patients who are intolerant to Endothelial Cell Density
contactlenses,spectacles,orboth.Ofthe3currentlyexist-
AllECDcountswereperformedbyanindependentemployee.The
ing phakic lens models (iris fixated, angle supported, and
ECDcountsweredeterminedbymanualcountingbeforeandafter
posterior chamber), we evaluated the Artisan iris-fixated
surgery using a specular microscope (Topcon SP-1000 and SP-
convex–concave PIOL.
2000P Non-Contact Specular Microscope; Topcon Corp., Tokyo,
BecausePIOLsareimplantedinhealthyandphakiceyes, Japan). During measurements, 3 consecutive endothelial images
itisrequiredthattheimplanteddeviceprovidealong-term were obtained. The estimated ECD for each eye was measured
tolerance by the ocular tissues. A lack of reports on the using the mean value of the 3 consecutive ECD measurements.
long-term stability and predictability of these types of re- AnyECDlosswasdefinedasthedecreaseincelldensitybetween
fractive surgery procedures remains an important issue thepreoperativeexaminationandthepostoperative(e.g.,1,6,and
amongeyesurgeons.Theimplantationofthelensleadingto 10 years) examination, expressed as a percentage of the preoper-
ativeECD.
chronic stress on the corneal endothelium with a concomi-
tant corneal endothelial cell loss is of particular concern.
Short-term clinical reports have demonstrated that corneal Surgical Procedure
endothelial cell loss after Artisan PIOL implantation varies
Allsurgicaltreatmentswereperformedbyonesurgeon(CJB)ina
from 0.7% to 2.4% after 1 year and 0.7% to 11.7% after 3
private clinic in Sint-Truiden, Belgium. The power of the PIOL
years.1–3,5,6,8–10 wascalculatedusingtheVanderHeijdeformula,whichusesthe
The purpose of this study was to assess the long-term mean corneal curvature (K), adjusted anterior chamber depth
(10-year) performance of the Artisan PIOL for the correc- (ACD(cid:1)0.8 mm), and spherical equivalent (SE) of the patient’s
tion of moderate to severe myopia. The Artisan PIOL is a spectaclecorrectionata12.0-mmvertex.18TheArtisaniris-fixated
lens with a fixed optical zone of 5.0 or 6.0 mm, depending PIOLhasaconvex-concavepolymethylmethacrylateopticthatis
on the dioptric power of the lens. The main outcome mea- availablewithanopticofeither6mm(forintraocularlenspowers
up to –15.5 diopters [D]) or 5 mm (for intraocular lens powers
sures that were investigated included refractive stability,
from –16.0 D up to –24.0 D). For this study, only the Artisan
refractive predictability, safety, efficacy, BCVA, uncor-
myopia5-mmopticlens(model206)wasused.Thelensis8.5mm
rected visual acuity (UCVA), intraocular pressure, intraop-
inoveralllength,hasavaultof0.8mm,andisavailableinpowers
erative problems, and corneal endothelial cell loss over a from(cid:1)5.0to(cid:1)20.0D.Before1997,thelenswasavailableinonly
period of 10 years. 1.0-Dpowerincrements;since1997,ithasbeenavailablein0.5-D
increments.TheArtisanPIOLispositionedintheanteriorcham-
berandisheldinplacebyfixationtothemidperipheralirisstroma,
Patients and Methods creatingabridgeovertheopticalaxis.
Forallpatients,surgerywasperformedundergeneralanesthe-
sia. All eyes received identical surgical treatment. A 2-plane
Patient Population and Study Design
6.3-mm corneoscleral incision was centered at 12 o’clock. Two
Patientsoriginallywereidentifiedandunderwentsurgeryin1991. paracenteseswereplacedat2and10o’clockanddirectedtoward
The initial study group consisted of 177 eyes of 89 patients who the enclavation sites. Miosis was achieved through preoperative
had undergone surgical implantation of an Artisan PIOL for the instillationofpilocarpine(IsoptoCarpine;Alcon,FortWorth,TX)
correction of moderate to high myopia. Of the original group of and a perioperative intracameral injection of acetylcholine 1.0%
177 eyes of 89 patients, a group of 89 eyes of 49 patients were (Miochol-E; Bournonville Pharma, The Hague, The Netherlands)
evaluated1,6,and10yearsafterthesurgicalprocedure.Datafrom to prepare the iris for PIOL fixation, to reduce the risk of
the remaining 88 eyes were excluded from analyses in the study lens-touch during implantation, and to facilitate centration of
because of differing time points of clinical evaluation. Compari- the PIOL. A viscoelastic substance (Healon GV; Pharmacia,
sonsofpreoperativeandpostoperativeclinicaldataweremadefor Uppsala, Sweden) was inserted through the paracenteses and
all eyes. Institutional Review Board approval was obtained from primaryincisiontomaintainsufficientanteriorchamberdepth,to
theAcademicHospitalMaastricht. protecttheendothelium,andtofacilitateadjustingthePIOLwithin
the eye during fixation. The PIOL was introduced with a Budo
forceps (Duckworth and Kent, Ltd., Baldock Herts, England).
Inclusion Criteria AftersubtlerotationofthePIOL,itwasfixatedinthehorizontal
axis with the use of a disposable enclavation needle (Ophtec). A
Included patients had a stable refraction during the previous 2 slitiridotomywasperformedat12o’clocktoavoidpupillaryblock
years;ananteriorchamberdepthof3.0mmormore;anendothe- glaucoma.Theviscoelasticsubstancewasexchangedforbalanced
lialcelldensity(ECD)countof2000cells/mm2ormore;anormal salt solution (Alcon). The wound was sutured with 3 to 5 inter-
pupilandirisconfiguration;nohistoryofglaucoma;nopreexistent rupted10-0nylonsutures(Alcon).Aftersurgery,topicaltobramy-
corneal, lenticular, or retinal pathologic features likely to alter cin0.3%combinedwithdexamethasone0.1%(TobraDex;Alcon,
vision;andnohistoryofchronicorrecurrentuveitis. Couvreur, Belgium) and ketorolac trometamol 0.5% (Acular;
WestportCo.,Mayo,Ireland)wereused4timesdailyfor3weeks
Clinical Evaluation inataperedscheduleand3timesdailyfor1week,respectively.
Before and after surgery, subjective and objective refraction was Glare
determined by measurement of the Snellen UCVA and BCVA.
Slit-lampmicroscopy,Goldmannapplanationtonometry,andfun- Glarelevelswereassessedusingaquestionnairethathasbeenused
dusexaminationwereperformed.Pupilsizesweremeasuredunder previouslyfortheevaluationofpatientsatisfactionafterrefractive
mesopic conditions using the Goldmann visual field analyzer surgery.16,18–20Theinstrumenthasproventobereliablebyahigh
(HaagStreit,Bern,Switzerland). levelofinternalconsistencywithCronbach’s(cid:1)coefficientssupe-
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Tahzib et al (cid:1) Long-term Results of Artisan Phakic IOL Implantation
riororequalto0.83.Glarescalescoresrangedfrom1(highglare Table2. Mean(cid:2)StandardDeviationSphericalEquivalent
levels)to5(noglare). beforeandafterArtisanPhakicIntraocularLensImplantation
fortheCorrectionofModeratetoHighMyopia
Statistical Analysis
Mean(cid:1)Standard Number P
Deviation ofEyes Range Value*
Best-correctedvisualacuityinlogarithmoftheminimumangleof
resolution(logMAR)unitswasusedfordatareports,meaningthe Beforesurgery (cid:1)10.37(cid:2)4.67 89 (cid:1)25.25to(cid:1)3.75
lower the value, the better the vision. Statistical analysis and Aftersurgery
comparisons between preoperative and postoperative data and 1yr (cid:1)0.70(cid:2)0.97 89 (cid:1)4.88to1.75
betweenindividualpostoperativeyearswereperformedbypaired 6yrs (cid:1)0.71(cid:2)0.99 89 (cid:1)4.50to2.0 0.94
Student’s t tests (P(cid:4)0.05 being significant; SPSS for Windows; 10yrs (cid:1)0.70(cid:2)1.00 89 (cid:1)4.00to2.0 0.71
SPSSInc.,Chicago,IL).Allvaluesinthetextaremean(cid:2)standard
deviation (SD). Data from clinical evaluations at postoperative
*Mean spherical equivalent value as compared with the mean value at
years 1, 6, and 10 were used for analysis. A linear decrease of 1yearaftersurgery.
0.6% physiologic loss per year was applied for the preoperative
ECD value, after which paired t tests were used to compare
postoperativeECDvalueswiththepreoperativeECDvalues.
(cid:1)0.70(cid:2)1.00D(range,(cid:1)4.00to2.00D),respectively.Nosignif-
icant change in mean SE was found between 1 and 6 years after
surgery and between 6 and 10 years after surgery (P (cid:3) 0.94 and
Results P(cid:3)0.71,respectively;Table2,Fig1).
Patient Population
Refractive Predictability
Thirty-four patients were women and 15 were men. The mean
preoperative age for all patients was 38.3(cid:2)10.5 years (range, SphericalEquivalent. ThedeviationoftheachievedSEcorrec-
19–61years).PopulationcharacteristicsarelistedinTable1.The tionfromthecalculated(intended)refractiveSEcorrectionwas
baseline parameters for all 89 eyes were a mean sphere of calculated. After 1, 6, and 10 years, 38.3% (n (cid:3) 34), 50.5%
(cid:1)9.78(cid:2)4.43 D (range, (cid:1)3.50 to (cid:1)25.00 D), a mean refractive (n (cid:3) 45), and 43.8% (n (cid:3) 39) of eyes were within (cid:2)0.5 D of
cylinder of (cid:1)1.26(cid:2)1.40 D (range, (cid:1)6.75 to 0 D), and a mean the desired refraction, respectively. After 1, 6, and 10 years,
baselineSEof(cid:1)10.36(cid:2)4.69D(range,(cid:1)3.75to(cid:1)25.25D). 74.2% (n (cid:3) 66), 65.1% (n (cid:3) 58), and 68.8% (n (cid:3) 61) of eyes
The mean baseline logMAR BCVA was 0.16(cid:2)0.23 (range, were within (cid:2)1.0 D of the desired refraction, respectively.
0–1). The mean anterior chamber depth was 3.30(cid:2)0.28 mm After1,6,and10years,94.4%(n(cid:3)84),93.3%(n(cid:3)83),and
(range, 3.00–4.20 mm), and the mean intraocular pressure was 93.3% (n (cid:3) 83) of eyes were within (cid:2)2.0 D of the desired
14.7(cid:2)2.8 mmHg (range, 8.0–19.0 mmHg). The mean baseline refraction, respectively (Table 3, Fig 2).
ECD was 2817(cid:2)359 cells/mm2 (range, 2100–3900 cells/mm2). Astigmatic Correction. After 1, 6, and 10 years, the mean
The mean power of the implanted PIOL was (cid:1)12.60(cid:2)4.20 D refractivecylinderwas(cid:1)1.02(cid:2)0.85D(range,(cid:1)4.00to0D;n(cid:3)
(range, (cid:1)7.0 to (cid:1)20.0 D). The preoperative pupil size was 89), (cid:1)1.00(cid:2)0.90 D (range, (cid:1)4.00 to 0 D; n (cid:3) 89), and
4.5(cid:2)0.9mm(range,3.0–7.0mm),withapupilsizelargerthan5.0 (cid:1)0.94(cid:2)0.79 D (range, (cid:1)4.00 to 0 D; n (cid:3) 89), respectively. A
mmin9.5%ofeyes. postoperativerefractivecylinderofmorethan1.5Dwasfoundin
15.7%(n(cid:3)14),20.2%(n(cid:3)18),and12.4%(n(cid:3)11)after1,6,
and10years,respectively(Table4).
Refractive Stability
After1,6,and10years,themeanSEwas(cid:1)0.70(cid:2)0.97D(range, Safety
(cid:1)4.88 to 1.75 D), (cid:1)0.71(cid:2)0.99 D (range, (cid:1)4.50 to 2.00 D), and
The mean preoperative logMAR BCVA for all 89 eyes was
Table1. SummaryofPopulationCharacteristicsand 0.16(cid:2)0.23 (range, 0–1). After 1, 6, and 10 years, the mean
PreoperativeData logMAR BCVA was 0.07(cid:2)0.09 (range, (cid:1)0.08 to 0.30),
0.12(cid:2)0.17 (range, (cid:1)0.08 to 1.30), and 0.12(cid:2)0.21 (range, (cid:1)0.08
Mean(cid:1)Standard to 1.30), respectively. A BCVA of 20/40 or better was found in
Variable Deviation Range 100%,96.6%,and93.3%ofeyesafter1,6,and10years,respec-
tively.ABCVAof20/20orbetterwasfoundin70.8%,50.6%,and
Meanpatientage(yrs) 38.35(cid:2)10.50 19–61
52.8%ofeyesafter1,6,and10years,respectively.After1,6,and
Numberoffemales 34 10years,40.3%(n(cid:3)31),26.0%(n(cid:3)20),and31.2%(n(cid:3)24)
Numberofeyes 89
gained1ormoreSnellenlinesofBCVA,respectively.After1,6,
Righteyes 44
and 10 years, 1.3% (n (cid:3) 1), 2.6% (n (cid:3) 2), and 2.6% (n (cid:3) 2) of
Lefteyes 45
Sphere(D) (cid:1)9.78(cid:2)4.43 (cid:1)3.50to(cid:1)25.00 eyeslostmorethan2SnellenlinesofBCVA,respectively(Fig3).
Cylinder(D) (cid:1)1.26(cid:2)1.40 (cid:1)6.75to0.00 The safety index (meaning the ratio of the mean postoperative
SE(D) (cid:1)10.36(cid:2)4.69 (cid:1)3.75to(cid:1)25.25 BCVAtothemeanpreoperativeBCVA)was1.12,1.10,and1.10
ACD(mm) 3.30(cid:2)0.28 3.00–4.20 after1,6,and10years,respectively.
IOP(mmHg) 14.7(cid:2)2.8 8.0–19.0
ECD(cells/mm2) 2817(cid:2)359 2100–3900
Efficacy
Implantedlenspower(D) (cid:1)12.60(cid:2)4.20 (cid:1)7.00to(cid:1)20.0
After 1, 6, and 10 years, the mean logMAR UCVA for all 89
ACD(cid:3)anteriorchamberdepth;D(cid:3)diopters;ECD(cid:3)endothelialcell eyeswas0.16(cid:2)0.16(range,(cid:1)0.08to0.60),0.24(cid:2)0.23(range,
density;IOP(cid:3)intraocularpressure;SE(cid:3)sphericalequivalent. 0–1.30),and0.27(cid:2)0.29(range,(cid:1)0.08to1.30),respectively.A
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Ophthalmology Volume 114, Number 6, June 2007
Figure1. GraphdemonstratingthestabilityofpostoperativesphericalequivalentafterArtisanphakicintraocularlensimplantationforthecorrection
ofmoderatetohighmyopia.Mean(cid:2)standarddeviationsphericalequivalentbeforeimplantation((cid:1)10.36(cid:2)4.69;n(cid:3)89)andafter1year((cid:1)0.70(cid:2)0.97;
n(cid:3)89),6years((cid:1)0.71(cid:2)0.99;n(cid:3)89),and10years((cid:1)0.70(cid:2)1.02;n(cid:3)69)aredemonstrated(P(cid:5)0.05).D(cid:3)diopters.
UCVA of 20/40 or better was found in 86.5%, 78.7%, and 2734(cid:2)360cells/mm2(range,2163–4500cells/mm2;n(cid:3) 89),and
82.0% of eyes after 1, 6, and 10 years, respectively. The 2800(cid:2)292 cells/mm2 (range, 1849–3850 cells/mm2; n(cid:3) 89),
efficacyindex(meaningthemeanpostoperativeUCVAtomean respectively(Fig4).Tocomparepreoperativevalueswithpostop-
preoperativeBCVA)was0.96,0.83,and0.80after1,6,and10 erativevalues,weassumedalineardecreaseof0.6%physiologic
years, respectively. lossperyearforthepreoperativevalue.Afterthisadjustment,we
found a mean decrease of (cid:1)9.39(cid:2)18.56% (range, (cid:1)57.47% to
17.36%; P (cid:3) 0.002), (cid:1)3.26(cid:2)18.96% (range, (cid:1)72.89% to
Intraocular Pressure
27.62%; P (cid:3) 0.494), and (cid:1)8.86(cid:2)16.01% (range, (cid:1)51.69%
to 34.43%; P (cid:3) 0.001) at 1, 6, and 10 years of follow-up,
The mean preoperative intraocular pressure for all 89 eyes was
14.7(cid:2)2.8mmHg(range,8–19mmHg)andchangedto15.3(cid:2)3.3 respectively(Tables5,6).FortherelativeSD,wefoundawithin-
mmHg (range, 9–26 mmHg), 15.6(cid:2)3.8 mmHg (range, 9–24 subjects variation of 4%. The coefficient of repeatability was
mmHg),and15.5(cid:2)3.5mmHg(range,7–25mmHg)at1,6,and10 344.21–23Nosignificantcorrelationwasfoundbetweenthepreop-
yearsaftersurgery. erative anterior chamber depth and endothelial cell changes after
10years(r(cid:3)(cid:1)0.050;P(cid:3)0.747,respectively).
Endothelial Cell Density and Endothelial Cell Loss
Intraoperative Problems and Adverse Events
After 1, 6, and 10 years, the mean(cid:2)SD postoperative ECD was Therewerenointraoperativeproblems.Throughoutallfollow-up
2928(cid:2)351 cells/mm2 (range, 2200–3900 cells/mm2; n(cid:3) 87), years,atotalof5eyesof3patientsdemonstratedalossofmore
than2SnellenlinesofBCVA.Forfollow-upyear1(n(cid:3)1),the
Table3. OverviewofRefractivePredictabilityafterArtisan
losswascausedbythedevelopmentofamyopicmaculopathy.For
PhakicIntraocularLensImplantationfortheCorrectionof follow-upyear6(n(cid:3)2)andyear10(n(cid:3)2),thelossinSnellen
ModeratetoHighMyopia
lines was the result of the development of a cornea guttata dys-
trophyandofavisuallysignificantcataractandwerethesameeyes
Year1 Year6 Year10 inbothyears.
Refractive No.ofEyes No.ofEyes No.ofEyes
Predictability (%;n(cid:2)89) (%;n(cid:2)89) (%;n(cid:2)89)
Glare
(cid:2)0.5D 38.3(32) 50.5(45) 43.8(39)
(cid:2)1.0D 74.2(66) 65.1(58) 68.8(61) After10years’follow-up,thescoresfor3opticalsideeffectsfor
(cid:2)2.0D 94.4(84) 93.3(83) 93.3(83) all 49 patients were assessed. The mean scores for perception of
stars around lights, distortion of details, and double outline of
imageswere4.49(cid:2)0.65,4.69(cid:2)0.59,4.69(cid:2)0.62,respectively(Ta-
D(cid:3)diopters.
ble7).
1136
Tahzib et al (cid:1) Long-term Results of Artisan Phakic IOL Implantation
Figure2. Scatterplotdemonstratingtherefractivepredictabilityofthesphericalequivalent10yearsafterArtisanphakicintraocularlensimplantation
forthecorrectionofmoderatetohighmyopia;65.2%(n(cid:3)45)werewithin(cid:2)1.0diopter(D)ofthedesiredrefraction.
Secondary Surgical Intervention long-term studies in the field of refractive surgery is the
variationinfollow-uptime.Inourstudy,ofthe177eyesof
To correct a significant postoperative undercorrection, 1 eye un-
89 patients who initially had undergone Artisan PIOL im-
derwentanuneventfuladditionalexcimerphotorefractivekeratec-
plantation,wewereabletoinclude89eyesof49patientsin
tomyprocedure4monthsafterthesurgicalimplantation.Because
thestudytoperformapairedcomparativeanalysisbetween
ofavisuallysignificantage-relatedcataractthatdeveloped6years
aftersurgery,2eyesunderwentexplantationoftheArtisanPIOL
with subsequent phacoemulsification and the implantation of a
posteriorchamberintraocularlens.
Discussion
The purpose of this retrospective study was to evaluate the
long-term (10 years) refractive stability, refractive predict-
ability, safety, and efficacy of the Artisan PIOL for the
correction of moderate to high myopia and to monitor
changesincornealECDovertime.Apotentialdrawbackof
Table4. OverviewofRefractiveCylinderValues(Diopters)
afterArtisanPhakicIntraocularLensImplantationforthe
CorrectionofModeratetoHighMyopia
Mean(cid:1)Standard
Deviation Range No.ofEyes
Beforesurgery (cid:1)1.26(cid:2)1.40 (cid:1)6.75to0.0 89
Figure 3. Bar graph demonstrating the lost and gained Snellen lines of
Aftersurgery
best-correctedvisualacuity(BCVA)afterArtisanphakicintraocularlens
Year1 (cid:1)1.02(cid:2)0.85 (cid:1)4.0to0.0 89
Year6 (cid:1)1.0(cid:2)0.90 (cid:1)4.0to0.0 89 implantationforthecorrectionofmoderatetohighmyopia.After1,6,
Year10 (cid:1)0.94(cid:2)0.79 (cid:1)4.0to0.0 89 and10years,1.3%(n(cid:3)1),2.6%(n(cid:3)2),and3.6%(n(cid:3)2)ofeyeslost
morethan2SnellenlinesofBCVA,respectively.
1137
Ophthalmology Volume 114, Number 6, June 2007
Figure 4. Graph demonstrating the mean(cid:2)standard deviation endothelial cell density before Artisan phakic intraocular lens implantation for the
correctionofmoderatetohighmyopia(2817(cid:2)359;n(cid:3)89)andafter1year(2928(cid:2)351;n(cid:3)89),6years(2734(cid:2)360;n(cid:3)89),and10years(2776(cid:2)321;
n(cid:3)69).
the individual follow-up years 1, 6, and 10. Data from the The long-term data demonstrated in this study showed
excluded 88 eyes were measured at different time points, comparableresultstotheabove-mentionedshort-termstud-
andthereforewerenotsuitablefortheintendedcomparative ies on refractive stability. Ten years after Artisan PIOL
analysis. However, none of these eyes had lost 2 or more implantationforthecorrectionofmoderatetohighmyopia,
lines of BCVA at their last follow-up visit. the mean SE ((cid:2)SD) was (cid:1)0.70(cid:2)1.00 D (range, (cid:1)4.00 to
2.00 D) and remained stable over time. This finding is in
accordance with the short-term literature, which demon-
Long-term Refractive Stability
strated stabilization of the postoperative refraction within
Theshort-termresultsofArtisanPIOLimplantationhavebeen the first few years after surgery (see above). The mean SE
demonstratedinseveralclinicalreportswithafollow-uptime values of (cid:1)0.7 D after 1, 6, and 10 years indicate a slight
of up to 4 years.1,3–7,9,10,24 These reports demonstrate that average undercorrection. The SE was aimed at slight myo-
stabilization of the postoperative refraction occurs within the pia, because the lens was available in only 1.0-D power
firstfewyearsaftersurgerywithmorethan90%ofeyesthat increments before 1997 (since 1997, the lens has been
achievearefractionwithin1Doftheintendedcorrectionand availablein0.5-Dincrements),andcarewastakentoavoid
ahighsafetyindex. a postoperative hyperopic overcorrection that certainly
Table5. Mean(cid:2)StandardDeviationEndothelialCellDensityCountsbeforeandafterArtisanPhakicIntraocularLensImplantation
fortheCorrectionofModeratetoHighMyopia
EndothelialCellDensity(cid:1)Standard EndothelialCellDensity
No.ofEyes Deviation(Range),cells/mm2 Range Loss(cid:1)StandardDeviation(%) PValue*
Beforesurgery 89 2817(cid:2)359 2100–3900
Aftersurgery
1year 89 2928(cid:2)351 2200–3900 (cid:1)9.39(cid:2)18.56 0.002
6years 89 2734(cid:2)360 2163–4500 (cid:1)3.26(cid:2)18.96 0.494
10years 89 2800(cid:2)292 1849–3850 (cid:1)8.86(cid:2)16.01 0.001
*Meanpostoperativeendothelialcelllossascomparedwiththemeanpreoperativevalue.
1138
Tahzib et al (cid:1) Long-term Results of Artisan Phakic IOL Implantation
Table6. ComparisonbetweenPreviousStudiesandtheCurrentStudy
Menezoetal9 Budoetal1 ElDanasouryetal3 PopandPayette10 CurrentStudy
No.ofeyes 111 518 43 765 89
Follow-up(mos) 6–48 6–36 12 6–24 12–144
Meanpatientage(yrs) 34.9 36.4 NA NA 38.3
Lenspower(D) (cid:1)8.0to(cid:1)20.0 (cid:1)5.0to(cid:1)20.0 (cid:1)9.0to(cid:1)19.0 (cid:1)5.0to(cid:1)24.0 (cid:1)7.0to(cid:1)20.0
ECDchange(%)
1yearfollow-up 6.59(cid:2)2.93 2.4(cid:2)1.0 0.7(cid:2)1.1 (cid:1)0.87(cid:2)16.35 (cid:1)9.39(cid:2)18.56
3yearsfollow-up 11.68(cid:2)4.18 0.7(cid:2)1.0 NA NA (cid:1)8.86(cid:2)16.01*
D(cid:3)diopters;ECD(cid:3)endothelialcelldensity;NA(cid:3)notapplicable.
*Long-term(10-year)datamentionedforthecurrentstudy.
would decrease patient satisfaction in our highly myopic In the eye with cornea guttata, it is unclear whether the
group of patients. In addition, we believe that a mean corneaguttatahaddevelopedinthe6yearsafterthesurgical
postoperative SE of (cid:1)0.7 D in this highly myopic group procedure,orwhetheritwasactuallypresentatthetimeof
with a preoperative SE of (cid:1)10.36 is an acceptable result. patient inclusion and escaped diagnosis. Endothelial cell
At10yearsaftersurgery,65.2%and92.8%ofeyeswere counts of more than 2000 cells/mm2 may be possible in
within(cid:2)1.0Dand(cid:2)2.0Dofthedesiredrefractionwithan patients with cornea guttata because of the variations in
excellent stability of the postoperative refractive cylinder, regional endothelial cell density.25
the mean(cid:2)SD refractive cylinder being (cid:1)0.99(cid:2)0.81 D From 1 to 10 years after surgery, there was a slight
(range, (cid:1)4.00 to 0 D) at 10 years. decrease in the safety index and a larger decrease in the
efficacy index of the Artisan procedure. After 10 years, we
found a safety index of 1.10 as compared with 1.12 at
Visual Outcome and Visual Complications
1year.Theefficacyindexdecreasedfrom0.96at1yearto
Short-term data showed that after Artisan PIOL implanta- 0.80 after 10 years. We believe that this decrease is not
tion,morethan85%ofeyesdemonstratedaBCVAof20/40 relatedtothesurgicalprocedure,buttothedevelopmentof
or better and more than 60% of eyes gained 2 or more age-andhighmyopia-relatedchanges,likeearlierdevelop-
Snellen lines of BCVA.1,3–7,9,10,24 ment of lens opacities and maculopathy in this group of
Our long-term data show great similarity to the short- highly myopic patients whose average patient age after 10
termdata.After10years,patientsreachedaBCVAof20/40 years was 48.3 years.1,5,26–28 It can be expected that a
or better in 92.5% of eyes and a UCVA of 20/40 or better samplesizeofapproximately100casescandetectunantic-
in 79.7% of eyes. With respect to safety, we showed that ipated severe adverse events to occur approximately 3% of
after10years,3.6%(n(cid:3)2)ofeyeslostmorethan2Snellen the time. Our study sample demonstrated unanticipated se-
lines of BCVA. Throughout all follow-up years, 5 eyes in vere adverse events to occur at a rate of less than 5%.
total demonstrated a loss of more than 2 Snellen lines of
BCVA. For year 1 (n (cid:3) 1), the loss was caused by the Long-term Endothelial Cell Loss
developmentofamyopicmaculopathy.Forfollow-upyears
Several short-term studies evaluated corneal ECD after
6 (n(cid:3) 2) and 10 (n (cid:3) 2), the loss in one eye of the same
Artisan PIOL implantation (Table 6).1,3–10,24,29 In 1998,
patientwastheresultofthedevelopmentofacorneaguttata
Menezo et al9 showed data from 111 eyes with an Artisan
dystrophy without preexistent signs of cornea guttata or a
PIOL with subsequent ECD loss of 11.7% at 3 years of
low endothelial cell count, and in the eye of a another
follow-up. In 2000, Budo et al1 reported 3-year follow-up
patient the result of a visually significant cataract. We
data from 518 patients that demonstrated a relatively low
believe that the loss of visual acuity was not related to the
amountofECDlossandstabilizationovertime(2.4%after
implantationofthePIOL,butrathertothenatureofmyopic
1 year and 0.7% after 3 years). In 2004, Pop and Payette10
eye disease and earlier development of cataract in myopia.
reported data that did not show any statistically significant
postoperative endothelial cell loss for up to 2 years after
Table7. GlareScores10YearsafterArtisanPhakicIntraocular Artisan PIOL implantation. No strong evidence can be
LensImplantationfortheCorrectionofModeratetoHigh found in the literature for concerns on the long-term safety
Myopia(n(cid:3)49)
ofthecurrentArtisanPIOLdesign.In2000,anexperimen-
tal study used scanning electron microscopy to analyze the
Mean(cid:1)Standard
surface quality of the Artisan lens.30 The study stated that
Deviation* Range
the surface quality of this lens is excellent and that no
Perceptionofstarsaroundlights 4.49(cid:2)0.65 3–5
contraindications related to surface quality could be found
Distortionofdetails 4.69(cid:2)0.59 3–5
Doubleoutlineofimages 4.69(cid:2)0.62 3–5 for the implantation of these lenses into phakic eyes. In
addition, reports that have studied changes in ECD in
healthyemmetropiceyesdemonstrateacorrelationbetween
*Scoresof0to5(0(cid:3)highglarelevels,5(cid:3)noglare).
patient age and ECD. With age, the number of cells de-
1139