Visian ICL article

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JFO-489; No. of Pages 10 ARTICLE IN PRESS
Journal français d’ophtalmologie (2012) xxx, xxx—xxx

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ARTICLE ORIGINAL

Résultats à long terme de l’implantation phaque de
chambre postérieure pour la correction des
amétropies fortes
Long-term results of posterior chamber phakic intraocular lens implantation
for correction of high ametropia

M. Le Loir ∗, B. Cochener

Service d’ophtalmologie, hôpital Morvan, CHU de Brest, 5, avenue Foch, 29609 Brest cedex,
France

Recu le 6 janvier 2011 ; accepté le 23 juin 2011
¸

MOTS CLÉS Résumé
Implantation Objectif. — Évaluer l’efficacité, la stabilité et la sécurité de l’implantation phaque de chambre
phaque ; postérieure à l’aide de l’implant Visian ICL STAAR dans le traitement des amétropies fortes avec
ICL ; un recul moyen de cinq ans (de 3,5 à dix ans).
Suivi à long terme Patients et méthodes. — Nous avons réalisé une étude rétrospective monocentrique portant
sur 90 yeux de 53 patients amétropes forts (45 myopes, dix hypermétropes, 35 présentant un
astigmatisme combiné) opérés par un seul chirurgien, en utilisant principalement le modèle ICL
V4 (87 yeux). Nous avons évalué en pré- et postopératoire les principaux critères d’efficacité
réfractive, la densité cellulaire endothéliale, l’opacification cristallinienne et les dimensions
des différents compartiments intraoculaires.
Résultats. — L’acuité visuelle sans correction moyenne atteint 0,77 au 12e mois postopératoire ;
17 des 90 yeux ont bénéficié d’un traitement photoablatif complémentaire pour astigmatisme
résiduel. Quarante-huit pour cent des yeux implantés ont gagné au moins une ligne de meilleure
acuité visuelle corrigée. Après l’implantation, la diminution de la densité cellulaire endothéliale
est restée stable à 0,69 %/an, et 91 % des yeux n’ont pas présenté d’opacification cristallinienne.
Les distances moyennes endothélium/ICL et ICL/cristallin ont respectivement été mesurées à
2,41 mm et 0,52 mm. Enfin, le niveau de satisfaction des patients atteints 96 % au 36e mois
postopératoire.

∗ Auteur correspondant.
Adresses e-mail : matthieuleloir@gmail.com (M. Le Loir), beatrice.cochener@ophtalmologie-chu29.fr
(B. Cochener).

0181-5512/$ — see front matter © 2012 Publi´ par Elsevier Masson SAS.
e
doi:10.1016/j.jfo.2011.06.006

Pour citer cet article : Le Loir M, Cochener B. Résultats à long terme de l’implantation phaque de chambre postérieure
pour la correction des amétropies fortes. J Fr Ophtalmol (2012), doi:10.1016/j.jfo.2011.06.006

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2 M. Le Loir, B. Cochener

Conclusion. — Les résultats sont en faveur de l’efficacité, la stabilité et la sécurité de l’implant
phaque ICL V4 dans le traitement des amétropies fortes. Le suivi au long cours n’a pas mis en
évidence d’augmentation significative d’incidence de cataracte dans les yeux opérés.
© 2012 Publi´ par Elsevier Masson SAS.
e

KEYWORDS Summary
Phakic intraocular Purpose. — To assess efficacy, stability and safety of posterior chamber phakic intraocular lens
lens implantation; implantation with STAAR Visian ICL for correction of high ametropia, with a mean follow-up of
Phakic IOL; 5 years (3.5—10 years).
ICL; Patients and methods. — Ninety eyes of 53 highly ametropic patients (45 myopia, ten hyperopia
Long-term follow-up and 35 with mixed astigmatism) were included in a retrospective single-surgeon study, using
primarily the V4 ICL model (87 eyes). We studied pre- and postoperative refractive efficacy,
endothelial cell density, crystalline lens opacification and intraocular clearances within the
various compartments of the eye.
Results. — Mean uncorrected visual acuity was 0.77 at the 12th postoperative month; 17 of 90
eyes required adjunctive photoablation for residual astigmatism. Forty-eight percent of eyes
gained at least one line of best corrected visual acuity. After implantation, the decrease in
endothelial cell density remained stable at 0.69%/year, and 91% of eyes showed no opacifi-
cation of the crystalline lens. Mean endothelium-ICL and ICL-crystalline lens distances were
2.41 mm and 0.52 mm respectively. Overall patient satisfaction achieved was 96% at 36 months
postoperatively.
Discussion and conclusion. — These results demonstrate efficacy, stability and safety of the
ICL V4 phakic IOL for the correction of high ametropia. Long-term follow-up did not show a
significant increase in cataract formation in implanted eyes.
© 2012 Published by Elsevier Masson SAS.

Introduction chirurgie incisionnelle, l’implantation intraoculaire torique
et la photoablation secondaire. Enfin, la grossesse est une
L’implantation phaque représente l’option chirurgicale contre-indication transitoire [1—3].
réfractive de choix pour la correction des amétropies fortes L’implantation phaque de chambre antérieure est deve-
(myopie supérieure à neuf dioptries, hypermétropie et astig- nue impopulaire en raison de complications tardives
matisme supérieurs à quatre dioptries). Elle reste une obtenues avec les implants à appui angulaire et à un moindre
alternative en cas d’intolérance aux lentilles de contact degré avec les implants à fixation irienne [4—8]. La plus
ou de contre-indication au LASIK (cornée fine ou oblate, redoutée est l’œdème cornéen par perte cellulaire endo-
opacités cornéennes, enophtalmie. . .). Au-delà des limites théliale, lié au contact mécanique des anses en appui sur
de la photoablation, elle respecte la cornée (et sa prola- l’endothélium, aux microtraumatismes mettant en contact
ticité), autorise une meilleure qualité de vision, offre une endothélium et implant au sein d’une chambre antérieure
réversibilité réfractive et anatomique, et enfin permet un trop étroite, ou à une mauvaise biotolérance du matériau
éventuel traitement photoablatif complémentaire (Bioptic). de l’implant. Citons également l’ovalisation pupillaire et la
Cette technique est le plus souvent réalisée de facon bila-
¸ cataracte précoce. Ces complications ont conduit au retrait
térale chez des patients âgés de 20 à 40 ans. du marché de la quasi-totalité des implants phaques de
Les contre-indications actuelles sont les suivantes : une chambre antérieure à appuis angulaires (à l’exception de
infection chronique des annexes oculaires, un antécédent de l’Acrysof phaque [Alcon® ]) et à la nécessité d’un suivi rigou-
chirurgie oculaire, de pathologie inflammatoire cornéenne reux à long terme [9,10].
et intraoculaire, de pseudoexfoliation ou de dispersion pig- L’implantation phaque de chambre postérieure peut être
mentaire, une insuffisance endothéliale (< 2000 cell/mm2 ), réalisée grâce à deux modèles d’implants. Le plus uti-
une hypertonie oculaire ou un glaucome, une opacification lisé, l’ICL (Implantable Collamer Lens, distribué par Staar
cristallinienne même débutante, un antécédent de décolle- Surgical® ) est constitué d’un matériel flexible et hydrophile,
ment rétinien ou de pathologie maculaire (à exclure par OCT le Collamer, dont l’indice de réfraction est de 1,45. Sa lar-
et/ou angiographie fluorescéinique), tout patient porteur geur est de 7,0 mm et la détermination de sa longueur (qui
d’une pathologie générale telle que le diabète sucré, une varie de 11,5 à 13 mm) repose en partie sur la distance
maladie auto-immune ou une pathologie systémique sévère « blanc à blanc » de limbe à limbe horizontal, approxima-
ou soumis à un traitement immunosuppresseur. De plus, tion du diamètre du sulcus ciliaire. L’optique, plan-concave,
comme dans toute chirurgie réfractive, en cas d’amblyopie présente un diamètre compris entre 4,5 et 5,5 mm selon la
minime et modérée, il faut prévenir le patient des limites puissance dioptrique de l’implant. Cet implant se positionne
de récupération. De même tout astigmatisme supérieur à en chambre postérieure, ses haptiques étant positionnées
1,5 dioptries ne constitue pas une contre-indication abso- dans le sulcus ciliaire (Fig. 1—3). Le PRL (Phakic Refrac-
lue mais il faudra évoquer la possibilité de choix parmi la tive Lens, distribué par Zeiss® ) fait de silicone, souple et


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Implantation phaque de chambre postérieure pour correction des amétropies fortes 3

Figure 3. Implant ICL en position précristallinienne (flèche)
lors d’un examen biomicroscopique en mydriase thérapeutique.
L’implant apparaît à distance de l’endothélium cornéen, et à dis-
tance de la cristalloïde antérieure (vault).

Depuis 1998, de nombreuses études ont démontré
l’efficacité et la prédictibilité réfractive de l’implantation
phaque de chambre postérieure [13—20] avec des résul-
Figure 1. Implant ICL sphérique (STAAR Surgical) souple, consti- tats comparables à ceux obtenus avec les implants phaques
tué de Collamer, de largeur 7 mm et de longueur comprise entre de chambre antérieure [21—25]. En revanche, la durée de
11,5 et 13 mm, avec une optique plan-concave de 4,5 à 5,5 mm de suivi souvent inférieure à trois années [13—20], ne permet-
diamètre selon la puissance. Les haptiques sont au contact du sulcus
tait pas de valider la sécurité de la technique vis-à-vis de
ciliaire.
complications à long terme : opacification cristallinienne,
perte cellulaire endothéliale, syndrome de dispersion pig-
élastique, repose théoriquement sur les fibres zonulaires et
mentaire, glaucome pigmentaire et blocage pupillaire.
se positionne librement en chambre postérieure.
Récemment, Kamiya et al. [26] ont conclu à l’efficacité
L’implantation précristallinienne est à ce jour restée
réfractive et la sécurité de l’implantation ICL avec un recul
de diffusion timide en France du fait de sa réputation
prolongé à 4 ans pour la correction des myopies comprises
d’inducteur de cataracte précoce de type sous-capsulaire
entre −4 et −15 dioptries. Pesando et al. [27] ont effec-
antérieur, notamment pour les premières générations d’ICL.
tué une étude avec dix ans de suivi mais uniquement sur
Mais la validation par la Food and Drug Administration
des patients hypermétropes. Notre travail est original à plu-
d’implants ICL V4 (quatrième génération) au dessin optimisé
sieurs titres. Avec un recul moyen proche de cinq ans, il
et le recul des implants de chambre antérieure expliquent
traite de l’implantation ICL pour corriger non seulement
sa diffusion exponentielle dans le monde [11—13].
les myopies, mais aussi les hypermétropies et astigmatismes
modérés à sévères, en s’affranchissant du biais « opérateur-
dépendant ».
Notre étude réalisée à l’aide de l’ICL V4 propose
d’évaluer l’efficacité réfractive et abérrométrique mais
également les sécurités anatomiques (endothéliale, cris-
tallinienne, angulaire irido-cornéenne) et pressionnelle
intraoculaire grâce à un suivi régulier et prolongé à dix ans.

Patients et méthodes
Nous avons réalisé une étude monocentrique rétrospec-
tive sur la période août 1998—novembre 2008, incluant
90 yeux de 53 patients forts amétropes (myopie comprise
entre − 6 et − 23 D, hypermétropie comprise entre + 4,5 et
+ 10 D ou porteurs d’un astigmatisme combiné compris entre
1,75 à 3,25 D), âgés de 18 à 44 ans, intolérants aux len-
Figure 2. Implant ICL torique (STAAR Surgical) positionné en tilles de contact et ne présentant pas de contre-indication
chambre postérieure ; les repères axiaux (flèches) diamétralement à l’implantation phaque. Tous les patients ont été opé-
opposés, et visualisables en mydriase extrême, sont alignés avec rés par le même chirurgien, à l’aide de l’implant phaque
l’axe de l’astigmatisme préopératoire. de chambre postérieure ICL STAAR® (3 V3 et 87 V4). La


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réfraction cible est l’emmétropie. Le calcul du diamètre de analysées par microscopie spéculaire non contact (moyenne
l’implant est basé sur la distance « blanc à blanc » mesurée de trois mesures) à l’aide du NonCon Robo CA (Konan® ). La
au biomicroscope et la puissance est déterminée à l’aide du topographie cornéenne, la pachymétrie centrale, la valeur
calculateur fourni par STAAR Surgical® . Ont été implantés de l’angle irido-cornéen, la profondeur de chambre anté-
55 ICL sphériques de puissance moyenne − 14,9 D pour les rieure et le diamètre pupillaire ont été précisés par le
myopes et + 7,5 D pour les hypermétropes et 35 ICL toriques Pentacam (Oculus® ). La distance endothélium cornéen/ICL,
(en cas d’astigmatisme préopératoire supérieur à 1 D). la distance ICL/cristallin, la valeur de l’angle irido-cornéen
Le même protocole opératoire a été respecté pour et la profondeur de chambre antérieure ont été rappor-
tous les patients. Sous anesthésie générale, pupille pré- tées par l’OCT de segment antérieur (Visante OCT, Zeiss® ).
parée en mydriase, l’incision principale est réalisée à L’épaisseur fovéolaire a été appréciée par l’OCT de segment
12 heures, d’une longueur de 3,2 mm et tunnellisée sur postérieur (Stratus OCT, Zeiss® ), et enfin la qualité de vision
2 mm. Le produit viscoélastique est injecté en regard du a été objectivée (RMS total, RMS high order aberration,
centre pupillaire afin de réaliser un matelas protecteur Blurry effect total, Blurry effect high order aberration) par
de la cristalloïde antérieure. L’introduction de l’implant aberrométrie wavefront (Wavescan, Visx® ).
dans la chambre antérieure se fait à l’aide d’un injec- L’ensemble de ces paramètres sont relevés en préopé-
teur, puis les haptiques sont prudemment positionnées en ratoire, puis au 1er mois postopératoire (M1), à M3, M6,
arrière de l’iris au moyen d’un micromanipulateur. Une M12 puis annuellement.
injection intracamérulaire d’acéthylcholine (Miochol® ) per- En présence d’une erreur réfractive résiduelle signifi-
met l’obtention d’un myosis. Une iridectomie périphérique cative (supérieure ou égale à 1 D) entre le quatrième et
linéaire perforante est réalisée avant lavage du viscoélas- le 12e mois postopératoire, un traitement complémentaire
tique. En fin d’intervention, l’étanchéité de l’incision est par photokératectomie réfractive (PKR) au laser excimer
assurée par suture de monofilament nylon 10.0 (ôtée à était alors proposé au patient. L’analyse statistique a été
J5 postopératoire). Les implantations bilatérales sont réa- réalisée grâce au logiciel Numbers de Mac OS X. Les compa-
lisées à une semaine d’intervalle. raisons de moyennes ont nécessité le t-test de Student, les
Pour chaque patient, les signes fonctionnels suivants comparaisons de pourcentages le test du Chi2 . Le seuil de
(douleurs oculaires, halos colorés, dédoublement, éblouis- significativité retenu était p < 0,05.
sement, confort en vision mésopique et photopique) ont
été relevés et côtés de l’absence totale de gêne (0) à la
gêne invalidante (3+) à l’aide d’un questionnaire de qualité Résultats
de vision. L’examen clinique complet s’est plus particu-
lièrement porté sur l’acuité visuelle sans correction, la Efficacité et prédictibilité réfractives
meilleure acuité visuelle corrigée, les réfractions manifeste
et cycloplégique (mesurée au plan lunettes avec respect En préopératoire, les réfractions manifestes en équivalent
d’une distance vertex de 12 mm), et sur l’examen biomi- sphérique (RMSE) moyennes sont respectivement de + 8,03
croscopique sans et avec dilatation pupillaire étudiant la (± 1,60) D et de − 12,06 (± 4,77) D pour les popula-
forme pupillaire, la dispersion pigmentaire, la profondeur tions hypermétrope et myope. L’âge moyen le jour de
de chambre antérieure, la transparence cristallinienne (à l’intervention est de 29,3 ans. La durée de suivi moyenne
l’aide de la Lens Opacification Classification Scale III), le s’étend à 4,7 années.
tonus oculaire et le fond d’œil. La densité et la morpholo- Au troisième mois postopératoire, l’acuité visuelle sans
gie cellulaires endothéliales cornéennes centrales ont été correction (AVSC) moyenne atteint 0,70 (± 0,22) ; elle est

Figure 4. Acuités visuelles sans correction obtenues du premier au 60e mois post-implantation (Visian ICL V4 ; STAAR Surgical).


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Figure 5. Pourcentage d’yeux avec ± 0,5 et ± 1,0 dioptrie (D) de la réfraction manifeste cible (en équivalent sphérique) du premier au
60e mois post-implantation ICL.

supérieure à 0,5 et 1 pour respectivement 85 % et 56 % La meilleure acuité visuelle corrigée (MAVC) moyenne
des yeux opérés (Fig. 4). La RMSE moyenne est alors de est passée de 0,64 ± 0,23 en préopératoire à 0,8 ± 0,21 au
0,53 ± 0,51 D. L’erreur réfractive résiduelle par rapport à 60e mois postopératoire. Au 48e mois postopératoire, 3 % des
l’emmétropie est de ± 1 D et de ± 0,5 D pour 78 % et 61 % des yeux opérés ont perdu deux lignes ou plus de MAVC, alors que
yeux opérés (Fig. 5). 48 % ont gagné au moins une ligne de MAVC (Fig. 6).
Au 12e mois postopératoire, alors que 17 des 90 yeux
ont bénéﬁcié d’un traitement PKR complémentaire, l’AVSC
moyenne atteint 0,77 ± 0,21 ; elle est supérieure à 0,5 et Sécurité endothéliale
1 pour respectivement 93 % et 63 % des yeux opérés. La RMSE
moyenne est de − 0,29 ± 0,32 D. L’erreur réfractive rési- La densité cellulaire endothéliale centrale préopératoire
duelle par rapport à la réfraction cible devient de ± 1 D moyenne était de 2587 ± 364 cellules/mm2 . La perte cellu-
et de ± 0,5D pour 89 % et 68 % des yeux opérés. Précisons laire a atteint 3,7 % la première année suivant la chirurgie,
que la valeur absolue moyenne de la correction PKR était puis 0,69 %/an en moyenne jusqu’au 60e mois postopératoire
de 1,11 ± 0,38 pour l’amétropie sphérique résiduelle et de (Fig. 7). Aucun patient n’a présenté de perte cellulaire endo-
1,56 ± 0,51 pour l’amétropie torique résiduelle. Au 60e mois théliale signiﬁcative.
postopératoire, l’AVSC moyenne est de 0,75 ± 0,28. La distance moyenne entre l’endothélium central cor-
Du 12e au 60e mois postopératoire, la variation moyenne néen et la face antérieure de l’ICL a été mesurée à
des RMSE est de 0,18 (± 0,37) D. 2,41 ± 0,35 mm au troisième mois postopératoire, stable

Figure 6. Évolution de meilleure acuité visuelle corrigée (en ligne de Snellen) rapportée au pourcentage des yeux implantés avec l’implant
Visian ICL (STAAR Surgical) au 48e mois postopératoire.


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Figure 7. Évolution de la densité cellulaire cornéenne endothé-
liale centrale (en cellules/mm2 ) avant et jusqu’à 60 mois après
implantation ICL (STAAR Surgical). Figure 8. Évolution de la distance séparant les centres de la face
postérieure de l’endothélium cornéen et de la face antérieure de
l’ICL jusqu’au’ 60e mois après implantation ICL (STAAR Surgical).
tout au long du suivi (p = 0,15 au 48e mois postopératoire),
en condition standard ou cycloplégique (p > 0,09) (Fig. 8).
cliniquement signiﬁcative, dont deux d’un patient implanté
Sécurité cristallinienne bilatéralement à 43 ans par des ICL V4 (cataractes survenues
entre les sixième et 12e mois postopératoires), et un seul
Quatre vingt-onze pour cent des yeux opérés n’ont d’un patient implanté unilatéralement à 45 ans par un ICL V3
pas présenté d’opaciﬁcation cristallinienne. Trois yeux (cataracte survenue au 48e mois postopératoire). Les deux
ont présenté une cataracte sous-capsulaire antérieure patients présentaient des myopies fortes (RMSE > −12,5 D).

Figure 9. Rapports intraoculaires (visante OCT, Zeiss® ) sur l’axe 0—180◦ en condition standard. La distance séparant les centres de
l’endothélium et de la face antérieure de l’ICL est de 2,33 mm. La distance séparant les centres de la face postérieure de l’ICL et de la
cristalloïde antérieure est de 0,67 mm. Le diamètre pupillaire est de 3,79 mm. La profondeur de chambre antérieure est mesurée à 3,28 mm.

Figure 10. Rapports intraoculaires (OCT visante) sur l’axe 0—180◦ en mydriase thérapeutique. La distance séparant les centres de
l’endothélium et de la face antérieure de l’ICL est de 2,39 mm. La distance séparant les centres de la face postérieure de l’ICL et de
la cristalloïde antérieure est de 0,69 mm. Le diamètre pupillaire est de 6,94 mm. La profondeur de chambre antérieure est mesurée à
3,39 mm.


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probablement liés à la rémanence de solution viscoélastique
au niveau du trabéculum.

Qualité de vision
Enfin, la qualité de vision subjective relevée au 48e mois
postopératoire souligne que seuls trois patients se plaignent
d’éblouissement, deux patients présentent des halos noc-
turnes, et deux autres patients décrivent un inconfort visuel.
Au sixième mois postopératoire, à la question : « Referiez-
vous la chirurgie ? » 96 % des patients répondent « oui ». La
qualité de vision objectivée par l’aberrométrie, retrouve
un taux d’aberrations d’ordre élevé notablement bas (RMS
hoa moyen égal à 0,25 [± 0,12]) pour un RMS total moyen
égal à 0,89 ± 0,32 et un Blurry effect hoa moyen égal à
0,21 ± 0,13 pour un Blurry effect total moyen égal à 0,63
Figure 11. Évolution de la distance séparant les centres de la face (± 0,28) au 36e mois postopératoire, mais l’échantillon étu-
postérieure de l’ICL et de la cristalloïde antérieure (vault) jusqu’au dié (28 yeux) est insuffisant pour être représentatif.
72e mois post-implantation ICL (STAAR Surgical).

Discussion
Les trois yeux ont bénéficié d’une bilensectomie (explan-
tation, phacoémulsification et implantation en chambre Les résultats de notre étude sont en faveur de l’efficacité
postérieure) avec un gain d’une ligne de MAVC par rapport réfractive, de la prédictibilité, de la stabilité et de la sécu-
à la situation pré-implantation phaque. rité à long terme de l’implantation ICL pour la correction
La distance moyenne séparant le cristallin de la face pos- des amétropies modérées à fortes. Depuis 1998, de nom-
térieure de l’ICL (appelée « vault ») en leur centre, a été breuses études ont démontré l’efficacité et la prédictibilité
mesurée à 0,52 ± 0,20 mm. Le « vault » ne varie significa- réfractive de l’implantation phaque de chambre postérieure
tivement ni avec le temps (p = 0,13), ni avec la dilatation [13—20] mais la durée de suivi inférieure à trois années,
pupillaire (p = 0,22) (Fig. 9—11). ne permettait pas de valider la sécurité de la technique à
long terme. Récemment, Kamiya et al. [26] ont conclu à
l’efficacité réfractive et la sécurité de l’implantation ICL
Sécurité irienne et camérulaire antérieure avec un recul prolongé à 4 ans pour la correction des myo-
pies comprises entre − 4 et − 15 dioptries. Notre étude est
L’étude de la tolérance irienne rapporte quatre cas de
originale à plusieurs titres. Avec un recul moyen proche
déformation pupillaire minime, deux cas d’hyporéactivité
de cinq ans, elle traite de l’implantation ICL pour corriger
pupillaire et huit cas de dispersion pigmentaire (dépôt
non seulement les myopies, mais aussi les hypermétropies
de pigment sur la cristalloïde antérieure). Le diamètre
et astigmatismes modérés à sévères, en s’affranchissant du
pupillaire réel préopératoire (5,73 ± 0,46 mm) n’est pas
biais « opérateur-dépendant ».
significativement modifié du premier au 48e mois suivant
En comparaison aux techniques de photoablation cor-
l’implantation (p = 0,19).
néenne, Sanders et Vukich ont démontré que l’implantation
La profondeur de chambre antérieure mesurée à l’aide de
ICL était supérieure au LASIK standard en termes d’efficacité
l’OCT de segment antérieur et du Pentacam, décroît légère-
et de sécurité pour la correction des myopies modérées à
ment (de 3,26 ± 0,24 mm en préopératoire à 3,17 ± 0,15 mm
sévères ainsi que pour la correction des myopies faibles
de facon stable jusqu’au 60e mois postopératoire) mais de
¸
[28—30]. La photoablation cornéenne, qui augmente avec
facon non significative (p = 0,14). Ajoutons que dans notre
¸
l’importance de l’amétropie à corriger est à l’origine
étude, la dilatation pupillaire n’a pas d’influence sur la pro-
d’aberrations d’ordre élevé (HOA), majorée en procédure
fondeur de chambre antérieure (p = 0,22).
LASIK standard par rapport à la procédure LASIK guidée
L’angle irido-cornéen subit une diminution d’environ
par aberromètre [31,32]. En attendant les résultats d’une
32 % après implantation (de 37 ± 6,7◦ à 25,2 ± 6,2◦ ) qui
étude randomisée comparant les deux techniques pour la
reste stable au terme du suivi. Notons qu’après dilatation,
correction des amétropies faibles à modérées, Igarashi a
l’angle irido-cornéen s’accroit significativement (p < 0,05)
démontré que l’implantation ICL induisait significativement
d’environ 25 %. (Fig. 9 et 10).
moins d’HOA et une meilleure sensibilité au contraste que
le LASIK guidé par aberrométrie pour la correction des myo-
Sécurité pressionnelle pies supérieures à − 6 dioptries [33] ; d’après Kamiya [34],
l’implantation ICL torique est supérieure au LASIK guidé par
La pression intraoculaire mesurée au tonomètre à applana- aberrométrie en termes de sécurité, efficacité, prédictibi-
tion ne semble pas influencée par l’implantation et ce, à lité et stabilité pour la correction des forts astigmatismes
long terme (13,6 ± 2,1 mmHg au 60e mois postopératoire). myopiques. L’implantation ICL induirait significativement
Nous avons rapporté trois cas d’hypertonie oculaire post- moins d’HOA du fait de la préservation du profil prolate de la
opératoire transitoires, résolus sous traitement médical et cornée [35], et une meilleure magnification rétinienne que


Modele +

(± 0,24) mm, peu différent de la mesure UBM de Pitault [37]
(402 ± 194 ␮m), et ne variant significativement ni avec le
temps ni avec la dilatation pupillaire. D’après Kamiya [40] le
« vault » diminue sensiblement avec le temps du fait du jeu
pupillaire, de l’épaississement cristallinien lié à l’âge et de
la position figée des haptiques de l’ICL ; dans la même étude,
le « vault » n’influence pas l’efficacité réfractive suggérant
qu’un positionnement strict de l’implant entre la face pos-
térieure de l’iris et le sulcus ciliaire conduit à une meilleure
prédictibilité réfractive.
Le diamètre pupillaire joue un rôle fondamental dans
les résultats réfractifs. L’étroitesse du rapport iris/ICL est à
l’origine de rares complications telles que le blocage pupil-
laire, le syndrome de dispersion pigmentaire, l’uvéite. . .
Keuch et Bleckmann [41] ont rapporté que les cycles de
contraction/dilatation pupillaire, le diamètre pupillaire et
l’amplitude de contraction pupillaire diminuaient après
Figure 12. Cataracte sous-capsulaire antérieure diffuse au neu- l’implantation suggérant une interférence mécanique de
vième mois post-implantation ICL (STAAR Surgical) nécessitant une
l’ICL avec la contraction pupillaire. Mais une étude plus
bilensectomie.
récente de Kamiya [42] portant sur 30 yeux, a démontré
que les diamètres pupillaire d’entrée et pupillaire réel
les techniques photoablatives, permettant une augmenta- diminuaient sensiblement le premier jour postopératoire
tion de la meilleure acuité visuelle corrigée [36]. avant de retrouver leur valeur préopératoire à la première
La perte cellulaire endothéliale centrale atteint à cinq semaine postopératoire, et ce de facon stable jusqu’au
¸
ans 6,4 % du capital préopératoire, soit 3,78 % la première 12e mois postopératoire, en faveur d’une irritation méca-
année principalement expliquée par l’incision cornéenne nique peropératoire et d’une réaction inflammatoire uvéale
peropératoire, puis 0,69 % par an en moyenne jusqu’au postopératoire immédiate. Notre étude n’a pas relevé de
terme du suivi, ce qui correspond à la perte physiologique modification significative du diamètre pupillaire du premier
annuelle admise (0,6 %). La diminution de la densité cellu- au 48e mois postopératoire. Les rares cas de déformation
laire endothéliale varie selon les études : de 3,7 % à quatre pupillaire, d’hyporéactivité pupillaire ou de dispersion pig-
ans pour Kamiya [26], de 6,5 % à deux ans pour Jiménez- mentaire à long terme soulignent l’inocuité mécanique et
Alfaro [16] ou de 8,4 à 9,7 % à trois ans selon l’étude FDA inflammatoire de l’implantation ICL.
[13]. Cette relative inocuité endothéliale s’explique par la Le rétrécissement significatif de l’angle irido-cornéen
biocompatibilité de l’ICL et par le respect d’une distance de d’environ 40 % selon Chung [43] (32 % dans notre étude) est
sécurité moyenne de 2,41 (± 0,23) mm entre l’endothélium stable au-delà du premier mois post-implantation ICL, et ne
central et la face antérieure de l’ICL. Pitault [37] a mesuré s’accompagne pas d’augmentation de la pression intraocu-
par biomicroscopie ultrasonore (UBM) cette même dis- laire ni de la pigmentation trabéculaire. Un suivi rigoureux
tance de sécurité moyenne de 2398 (± 203) ␮m sur 17 cas le premier mois postopératoire est cependant requis dans
d’implantation ICL. La PKR adjuvante pratiquée sur 17 yeux ce contexte.
n’a pas majoré la perte cellulaire endothéliale (− 6,2 %) Selon l’étude américaine FDA [44], l’implantation ICL
confirmant les résultats de Patel [38]. Signalons que le seul torique a fait preuve de son efficacité et de sa prédictibilité
implant phaque de chambre antérieure à appuis angulaires réfractives pour la correction des astigmatismes myopiques
encore disponible, l’implant Acrysof phaque (Alcon® ) ne modérés à forts. Schallhorn et al. [45] ont rapporté la
semble pas induire de majoration de la perte cellulaire supériorité de l’implantation ICL torique sur la PRK en
endothéliale à un an [21]. termes de sécurité, efficacité, reproductibilité et stabilité
Nous avons rapporté cinq cas d’opacification capsulaire réfractives.
antérieure (5,5 %) et trois cataractes cliniquement significa- En conclusion, l’implantation ICL est le traitement de
tives (3,3 %) induits par l’implantation ICL (Fig. 12). Les trois choix pour la correction des amétropies modérées à fortes
cas de cataracte ont concerné des patients de plus de 43 ans, en garantissant d’excellents résultats réfractifs et une
présentant des myopies fortes, et obtenu avec l’implant ICL sécurité stable dans le temps. La quête d’une efficacité
V3 pour un cas (Fig. 9 et 10). Les études de Gonvers [39], et d’une sécurité absolues de l’implantation phaque en
Lackner [12] et Sanders [11] identifient l’âge supérieur à chambre postérieure requiert deux conditions : d’une part,
45 ans, les myopies fortes, le traumatisme peropératoire, et le suivi rapproché et prolongé des patients implantés,
un design et une taille d’implant inadéquats comme des fac- d’autre part, l’accès au 3D sans extrapolation du sulcus
teurs de risque d’opacification capsulaire précoce. Kamiya postérieur — exclusivement accessible par l’échographie 3D
[26] a rapporté une incidence de 1,8 % de cataracte clini- haute fréquence — dans un double objectif : la prétention
quement significative à quatre ans avec l’ICL V4 ; Sanders de l’ajustage sur mesure de la taille de l’implant avec
[13] a rapporté une incidence de cataracte sous-capsulaire simulation préopératoire et l’aide au suivi postopératoire.
antérieure avec les modèles d’ICL V3 et V4 respectivement L’implantation ICL deviendrait alors une alternative à la
de 12,6 % et 2,9 %, probablement en raison du « vault » sup- photoablation cornéenne pour la correction des amétropies
plémentaire de 0,13 à 0,21 mm du modèle V4 par rapport faibles (sous réserve d’un niveau de sécurité et de prédicti-
au V3. Dans notre étude, le « vault » moyen était de 0,52 bilité acquis).


Modele +

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ARTICLE

Phakic Collamer Lens (ICL) Implantation Followed by
Excimer Laser Treatment (Bioptics) to Correct Hyperopia
with Astigmatism
José F. Alfonso1,2, Carlos Lisa1, Begoña Baamonde1,2, Paulo Fernandes3, Jorge Jorge3, Robert Montés Micó4

PURPOSE: To evaluate the efficacy and safety results of excimer corneal surgery following
posterior chamber phakic Implantable Collamer Lens (Bioptics) to treat hyperopia with
astigmatism.
SETTING: Fernández-Vega Ophthalmological Institute, Oviedo, Spain.
METHODS: This cohort study included 62 eyes who underwent ICH V3 implantation
followed by photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK) to
treat residual refractive errors (mainly astigmatism). Mean follow-up was 9.3±4.7 months
after laser ablation (range 1 to 29 months).
RESULTS: Preoperatively the average manifest refractive sphere (MRSE) was 5.73±1.79
diopters (D) (range 1.50 to 11.00) and manifest refractive cylinder (MRCYL) was
–2.07±1.03 D (range –4.00 to 0.00). Following ICH implantation, the mean spherical
equivalent (SE) was –0.07±0.09 D (range –2.88 to 0.75 D); after laser treatment the mean
MRSE was –0.01±0.08 D (range –0.5 to 0.25) and MRCYL was –0.19±0.36 D (range
–1.50 to 0.00). The mean UDVA was at least 20/25 in almost 70% of laser-treated eyes;
over 90% of the eyes achieved UDVA of 20/32 or better. No eye lost ≥2 lines of preoper-
ative CDVA and a loss of 2 lines of UDVA after laser treatment compared to the CDVA
after ICH implantation was noted in 4 (6.5%) eyes. After bioptics all eyes were within
±1.00 D and 60 eyes (96.8%) within ±0.50 D of SE.
CONCLUSION: Bioptics procedure combining posterior chamber phakic IOL implanta-
tion and corneal refractive surgery showed to be a safe procedure to treat hyperopia associ-
ated with astigmatism.
J Emmetropia 2011; 2: 181-187

INTRODUCTION

Submitted: 11/30/2011 The improvements in excimer laser technology
Accepted: 12/21/2011 made hyperopic excimer refractive surgery a valuable
1
option for hyperopia correction. However, despite the
Fernández-Vega Ophthalmological Institute, Oviedo, Spain.
2 Surgery Department, School of Medicine, Universidad de Oviedo, good visual and refractive outcomes of excimer laser
Spain. photorefractive keratectomy (PRK) and laser in situ
3 Clinical & Experimental Optometry Research Lab; Center of Keratomileusis (LASIK) treatments, they are more
Physics, School of Sciences. Universidade do Minho. Braga. Portugal. effective and stable for the correction of low degrees of
4 Optics Department, Faculty of Physics, Universidad de Valencia, hyperopia than high hyperopia1-7. Refractive regres-
Spain.
sion8,9 and significant increase in ocular and corneal
Acknowledgements and Disclosure: The authors have no propri- aberrations10,11 have been reported.
etary interest in any of the materials mentioned in this article. This The Implantable Collamer Lens (Visian ICL;
article was supported in part by a Ministerio de Ciencia e
Innovación Research Grant to Robert Montés-Micó (#SAF2009- STAAR Surgical, Nidau, Switzerland) is a foldable pha-
13342#) and a grant from de Fundação para a Ciência e Tecnologia kic intraocular lens (pIOL) designed to be placed in the
to Paulo Fernandes (#FCT-SFRH-BD-34303-2007#). posterior chamber behind the iris with the haptic zone
Address: José F. Alfonso MD, PhD, Instituto Oftalmológico resting on the ciliary sulcus and has demonstrated to be
Fernández-Vega, Avda. Dres. Fernández-Vega 114, 33012 (Oviedo), safe and effective among various clinical settings12-16,
Spain. E-mail: j.alfonso@fernandez-vega.com including hyperopia correction17-20. Currently, toric
© 2010 SECOIR ISSN: 2171-4703 181
Sociedad Española de Cirugía Ocular Implanto-Refractiva

182 CORNEAL LASER SURGERY AFTER ICL

ICL implants to correct hyperopia with astigmatism are the manufacturer using a modified vertex formula. The
still not available, and therefore, the pIOL could only ICL surgical procedure was the same as the one previ-
correct the spherical component of the refractive error ously reported by the authors22,23.
and as a result coexisting astigmatic error had to be
treated by either keratorefractive procedure. Combined
Laser surgery
phakic IOL implantation and corneal refractive surgery
was initially described by Zaldivar et al21 who termed LASIK or PRK were performed at least 3 months
the use of LASIK after pIOL implantation bioptics to after ICL surgery and every eye showed a stable refrac-
treat extreme myopia and myopia combined with astig- tion and corneal topographic pattern for at least 3
matism. However, to our knowledge there are no months before performing LASIK or PRK, both sur-
reports on bioptics to treat residual refractive error after geries were carried out by the same surgeon (JFA).
hyperopic ICL. With the present study we assessed the LASIK was performed in 50 eyes and PRK in 12
efficacy and safety results on bioptics with ICL implan- eyes depending on the corneal thickness and ablation
tation to treat hyperopia with astigmatism. depth of each patient.
In the case of myopic astigmatism, ablation was per-
formed in the steepest meridian (negative cylinder abla-
PATIENTS AND METHODS
tion). In the case of mixed astigmatism, half of the abla-
The study population comprised 62 eyes of 35 tion was performed in the steep meridian (negative cylin-
patients who underwent PRK or LASIK for the correc- der ablation) and half in the flat meridian (positive cylin-
tion of residual refractive errors after implantation of a der ablation), the so-called cross-cylinder technique.
Collamer pIOL for hyperopia correction (ICL) at the All surgical procedures were uneventful and with-
Fernández-Vega Ophthalmological Institute (Oviedo, out post-surgical complications within the follow-up
Spain) between February 2005 and April 2009. At the time presented in this study.
time of the surgery, all patients were fully informed of
the details and possible risks of the surgical procedures.
Postoperative Assessment
Written informed consent was obtained from all
patients before surgery in accordance with the Both after pIOL surgery and after LASIK/PRK all
Declaration of Helsinki and an institutional review the patients fulfilled the follow-up protocol in which the
board approved the study. examination visits were carried out at Day 1, Week 1,
The inclusion criteria for ICL implantation were cor- and Month 1, and then every 3 months as necessary.
rected distance visual acuity (CDVA) of 20/50 or better, Data obtained in each postoperative follow-up visit
stable refraction and clear central cornea. The exclusion included uncorrected distance visual acuity (UDVA),
criteria included age <22 years, anterior chamber depth CDVA, slit-lamp examination, refraction, ECD, fundus
<2.8 mm, endothelial cell density (ECD) examination, intra-ocular pressure (IOP) and central
<2000 cell/mm2, cataract, history of glaucoma or retinal separation between the lens anterior surface and the pos-
detachment, macular degeneration or retinopathy, terior surface of the ICL (Vault). For averaging, visual
neuro-ophthalmic diseases and history of ocular inflam- acuities were converted to logMAR values; then, the
mation. Before the ICL implantation, patients had a means and standard deviations were back calculated to
complete ophthalmologic examination, including mani- Snellen acuity. Sphero-cylindrical refractive results were
fest and cycloplegic refraction, keratometry, corneal converted into vectors expressed by three dioptric pow-
topography and pachymetry using the Orbscan II ers: M, J0, and J45; with M being equal to the spherical
(Bausch & Lomb, Rochester, NY), ECD (SP 3000P; equivalent (SE) of the given refractive error, and J0 and
Topcon Europe Medical, Netherlands), slit-lamp exami- J45 the two Jackson crossed cylinders equivalent to the
nation, Goldmann aplanation tonometry and binocular conventional cylinder. Manifest refractions in conven-
indirect ophthalmoscopy through dilated pupils. tional script notation (S [sphere], C [cylinder], · [axis])
were converted to power vector coordinates and overall
blurring strength using the formulas described by
ICL size and power calculation
Thibos and Horner24: M = S+C/2; J0 = (–C/2)*cos (2α);
All eyes were implanted with a model ICHV3 J45 = (–C/2)* sin (2α) and B = (M2 + J02+ J452)1/2.
(STAAR Surgical, Nidau, Switzerland). The ICL size Data analysis was performed using SPSS for
was individually determined based on the horizontal Windows version 16.01 (SPSS Inc. Chicago. IL).
white-to-white distance and anterior chamber depth Normality of data was checked by Kolmogorov-
(ACD) measured with Orbscan II (Bausch & Lomb. Smirnov test and analyzed using the Wilcoxon rank
Rochester, NY) following the manufacturer’s recom- sum test, or analysis of variance with multiple compar-
mendations. Power calculation for the ICL was per- isons correction where appropriate, to explore statisti-
formed using the software ICL power table provided by cal differences for refractive and visual acuity scores
JOURNAL OF EMMETROPIA - VOL 2, OCTOBER-DECEMBER

CORNEAL LASER SURGERY AFTER ICL 183

among different follow-up visits. Bivariate correlations Table 1. Descriptive statistics for demographic data of
between attempted versus achieved refraction were ana- patients and characteristics of implanted Hyperopic
lyzed using a non-parametric (Spearman’s coefficient) Implantable Collamer Lens
correlation analysis. Differences were considered to be
statistically significant when the p value was <0.05. Range
Mean SD
[Min, Max]

RESULTS Age (years) 27.6 4.3 [20,40]
Refractive sphere (D) 5.73 1.79 [1.50,11.00]
The mean age of the 35 patients, 19 women Refractive cylinder (D) –2.07 1.03 [–4.00,0.00]
(54.3%) and 16 men (45.7%), was 27.6 years ± 4.3 Flat keratometry 41.2 1.9 [36.5,45.8]
(SD) (range 20 to 40 years). The mean interval Steep keratometry 43.3 2.0 [39.0,47.8]
between ICL surgery and LASIK /PRK was 4.9± 3.9 ICL size (mm) 12.00 0.30 [11.5,12.5]
months (range 3 to 19 months). Fifty-one eyes had ICL sphere (D) 8.4 2.7 [3.0,14.0]
residual myopia or myopic astigmatism, 11 eyes had ECC (cells/mm2) 2775 313 [2105,3377]
White-White (mm) 11.9 0.4 [11.0,12.9]
mixed astigmatism after ICL surgery. Mean follow-up ACD (mm) 3.0 0.2 [2.8,3.4]
after laser treatment was 9.7±7.4 months (range 3 to CCT (µm) 538 54 [410,640]
27 months). Table 1 shows the preoperative patient
demographics and ICL characteristics. D: diopters; ICL: Implantable Collamer Lens; ACD: anterior
chamber depth; ECC: endothelial cell count; CCT: central corneal
thickness.
Refractive outcomes
The overall change in manifest refraction is shown ifest refractive sphere was 5.73±1.79 D (range 1.50 to
in Figure 1. Prior to ICL implantation, the mean man- 11.00 D) and the mean manifest refractive cylinder was
–2.07±1.03 (range –4.00 to 0.00 D). At the latest fol-
low-up visit following laser treatment the mean mani-
fest refractive sphere was –0.01±0.08 (range –0.50 to
0.25 D) and manifest refractive cylinder was
–0.19±0.36 (range –1.50 to 0.00 D). The distribution
of the refractive components after vector conversion
before and after the different laser treatments is shown
in table 2. No statistically significant differences existed
in the M, J0 or J45 components among patients under-
going either laser procedure. The power vector magni-
tude was reduced either after ICL surgery or after differ-
ent laser treatments and the mean value in all compo-
nents of refraction after laser surgery were neither clini-
cally nor statistically significant between the different
laser procedures (P>0.05, Kruskal-Wallis test for all vec-
tor components of refraction). Figure 2 shows the astig-
Figure 1. Time course of the Manifest refractive sphere (MRSE)
matic components of the power vector as represented by
and cylinder (MRCYL) in diopters (D) after laser surgery. the 2-dimensional vector plot (J0, J45). The dispersion

Table 2. Mean values and standard deviation (SD) of components of vectorial decomposition of refraction before and at different
follow-up times after surgery

Pre-operatively Pos ICL Pos Laser

M J0 J45 M J0 J45 M J0 J45

Mean±SD Mean±SD Mean±SD Mean±SD Mean±SD Mean±SD Mean±SD Mean±SD Mean±SD

LASIK 4.9±1.6 0.7±0.7 -0.1±0.5 -0.8±0.7 0.5±0.5 -0.1±0.4 -0.1±0.2 0.1±0.2 0.0±0.1
PRK 3.8±2.0 0.9±0.6 -0.1±0.7 -1.1±0.6 0.7±0.6 -0.1±0.5 -0.1±0.1 0.1±0.1 0.0±0.0
p* 0.085 0.755 0.914 0.211 0.880 0.928 0.896 0.742 0.727

SD: Standard deviation.
* Independent-Samples Kruskall-Wallis Test.



(100%) were within ±1.00 D, for J0 (r2=0.95) and J45
(r2=0.98), respectively, as shown in Figure 3.

Visual Outcomes
The change in uncorrected (UCVA) and corrected
(CDVA) distance visual acuity (decimal notation) is
summarized in Figure 4. Mean preoperative UDVA
was 0.39±0.22 Snellen lines and it was 20/200 or bet-
ter in all 62 eyes. Following phakic IOL implantation
it significantly improved in all but 1 eye (P<0.01,
Wilcoxon Test); the mean UDVA was 0.67±0.28 with
91% eyes achieving at least 20/63 or better (Figure 5).
Following excimer laser treatment the UDVA
improved in all eyes. It was at least 20/40 in 58
Figure 2. Scatter plot of the astigmatic vectors (J0 and J45) before
(93.5%) eyes and 20/25 or better in 43 (69.4%) eyes
and after Bioptics treatment. The more central location of postop- (P<0.01, Wilcoxon Test). Preoperative mean CDVA
erative data represents the reduction of preoperative astigmatism. was 0.84±0.21 and it was equal to or better than 20/40
in 58 eyes (93.5%) and equal to or better than 20/20
of preoperative data and its concentration around the
origin (0,0 coordinates) is apparent at the last follow-up
visit after Laser treatment. Sixty eyes (96.8%) were
within ±0.50 D for the M component and all eyes were
within ±1.00 D of the desired refraction (r2=0.99 for
attempted vs. achieved correlation analysis), while for
astigmatic components, 56 (90.3%) and 60 (96.8%)
eyes were within ±0.50 D and 61 (98.4%) and 62

Figure 4. Changes in mean decimal visual acuity over the entire
follow-up period after ICL implantation and laser surgery.

Figure 3. Plots of achieved against attempted correction (pre-
dictability) as spherical equivalent (M) and the astigmatic compo-
nents (J0 and J45) in diopters (D) at the last follow-up visit after
bioptics treatment. Coefficients of determination (r2) are 0.99, 0.95 Figure 5. Preoperative cumulative UDVA Snellen acuity versus post-
and 0.98 for M, J0 and J45, respectively. operative UDVA after pIOL implantation and after Laser surgery.



Figure 6. Preoperative cumulative CDVA Snellen acuity versus post- Figure 7. Changes in CDVA (safety) over the entire follow-up
operative CDVA after pIOL implantation and after Laser surgery. period and changes between UDVA after laser surgery when com-
pared with CDVA after ICL implantation.

in 25 eyes (40.3%) (Figure 6). Following phakic IOL chronic increased postoperative intraocular pressure
implantation the mean CDVA was 0.81±0.20 Snellen (IOP); 1 eye had a mild, transient increase in IOP up
acuity and it was equal to or better than 20/40 in 59 to 25 mmHg that did not require treatment. We did
(95.2%) eyes and 20/20 or better in 20 (32.3%) of not observe dislocation or decentration of the ICL and
eyes. After laser treatment the mean CDVA was no dehiscence of the ICL incision due to laser treat-
0.84±0.18 (p=0.632, Wilcoxon Test) and it was at least ment was observed either.
20/25 in 45 (72.6%) eyes and 20/20 or better in 21
(33.9%) eyes. Changes in CDVA (safety) over the fol-
low-up and the changes of CDVA after IOL implanta- DISCUSSION
tion when compared with UDVA after laser treatment In this prospective study with 62 eyes, high levels of
are shown in Figure 7. After phakic IOL implantation safety, efficacy and predictability were achieved for the
1 (1.6%) eye had lost more than 2 lines of CDVA, 6 combined use of a posterior chamber phakic IOL and
eyes (9.7%) had lost 2 lines, 17 eyes (27.4%) had lost LASIK or PRK (bioptics) in eyes with hyperopia and
1 line and 38 eyes (61.3%) had no change or improved astigmatism. After laser treatment, all eyes were within
CDVA from preoperatively. After laser treatment, no ±1.00 D of the predicted correction and nearly 97%
eyes lost more than 2 lines of preoperative CDVA, 5 were within ±0.50 D. Hyperopia and astigmatism was
(8.1%) eyes lost 2 lines and 10 eyes (16.1%) lost 1 line reduced from a mean +5.73 ± 1.79 D and –2.07±1.03 D
while 47 (75.8%) eyes maintained or gained lines of to –0.01 ± 0.08 D and –0.19±0.36 D, respectively, and
visual acuity. Both the safety index (ratio of postopera- astigmatic components (J0, J45) showed values over 95%
tive CDVA to the preoperative CDVA) and the effica- within ±1.00 D in all eyes (Figure 3 middle and bot-
cy index (ratio of postoperative UDVA to the preoper- tom). Moreover, we have observed good visual outcomes
ative CDVA) significantly improved after laser treat- in relation to the safety index (over 1.00) and the effica-
ment (P>0.05, Wilcoxon Test for both indexes); they cy index (about 1.00) with about 75% of eyes maintain-
were 1.04±0.21 and 0.99±0.20, respectively. ing or gaining several lines of CDVA.
Despite the improvement in UDVA after laser In 1999, Zaldivar et al21 presented the results of com-
treatment, when compared with CDVA after ICL bining ICL implantation and LASIK in 67 myopic eyes
implantation a loss of >2 lines of visual acuity was with SE of at least –18.00 D or with high levels of astig-
noted in 1 (1.6%) eye. Furthermore, a gain of 1 line matism. Fifty-seven eyes (85%) were within ±1.00 D of
was noted in 13 (21%) eyes and a gain of 2 lines was emmetropia and 45 (67%) within ±0.50 D; fifty-one
observed in 5 (8.1%) laser treated eyes. (76%) eyes gained 2 or more lines of CDVA and no eyes
lost 2 or more lines of CDVA at last examination.
Adverse Events Sánchez-Galeana et al25 report a series of 37 eyes of 31
patients who had PRK or LASIK for a residual refractive
There were no intraoperative complications. No error after ICL implantation. Three months after LASIK
ICL required explantation or repositioning, and no or PRK, the mean SE was within ±1.00 D in 97.2% of
ICL was decentered. There were no cases of pupillary eyes and within ±0.50 D in 83.7%. Arne et al26 report a
block or anterior subcapsular cataract. No eye had series of 32 eyes of 28 patients, (preoperative SE was


–18.70±5.67 D; range –7.75 to –29.00 D) and after CDVA; 6 (9.7%) lost 2 lines and 1 (1.6%) eye lost more
bioptics the postoperative SE was within ±1.00 D in than 2 lines (Figure 6). However, this effect has been par-
91.3% of eyes in the LASIK group and 97.6% of eyes in tially corrected after LASIK or PRK and it returned to
the PRK group. UDVA improved in all eyes but a loss of the preoperative levels after laser enhancement (Figure
1 line of the CDVA after ICL implantation occurred in 6); at the end of the bioptics procedure, 5 (8.1%) eyes
22.2% of PRK-treated eyes and in 13.6% of LASIK- lost 2 lines of CDVA but no eye lost 2 or more lines. The
treated eyes. These results, similar to those obtained in loss of CDVA after ICL implantation observed in this
the present study, indicate that the combination of the study could be explained by the decrease in the size of
Visian ICL and LASIK/PRK can be also successfully the retinal image that is produced in eyes with high
used in eyes with high hyperopia and astigmatism. hyperopia corrected by pIOLs28. In addition, a cornea
The safety and efficacy of ICL implantation to cor- with high astigmatism causes greater distortion of the
rect hyperopia was well established in several published retinal image than a cornea with low astigmatism. When
studies. Davidorf et al in 199819 described the implanta- LASIK or PRK is performed for the correction of astig-
tion of the Visian ICL lens in 24 hyperopic eyes with a matism, it is common to observe an increase in CDVA
mean SE of +6.51 ± 2.08 D (range, +3.75 to +10.50 D). after surgery29. Thus, a reduction in the amount of astig-
After a mean follow-up of 8.4 months, the postoperative matism through corneal refractive procedures such as
SE was –0.39±1.29 D (range, +1.25 to –3.88 D), with that obtained in this study could have improved visual
79% (19 eyes) within ±1.00 D and 58% (14 eyes) with- acuity, reducing the retinal image distortion.
in ±0.50 D of emmetropia. One eye lost 2 or more lines Studies of hyperopic PRK and hyperopic LASIK
of CDVA due to a progressive neovascular glaucoma, surgery showed similar outcomes in terms of residual
which was precipitated by an episode of postoperative ametropia (<1.00 D), and predictability (about 50%
pupillary block, while a gain of two or more lines of within ±0.50 D; about 70% within ±1.00 D)1,5,6,9.
CDVA was seen in 2 eyes (8%) and postoperative Sources of variability between them may include differ-
UDVA was 20/20 or better in 2 eyes (8%) and 20/40 or ences in the ablation zone parameters and the ablation
better in 15 eyes (63%). In the U.S. Food and Drug profile between the lasers; differences in the nomo-
Administration’s (U.S. FDA) trials, a Phase I study was grams used may account for the variation in the report-
initially published in 199917 including 10 hyperopic ed results. A similar behavior regarding predictability
eyes with a SE range of +2.50 to +10.875 D. Six months and regression of refractive effect is also observed, with
postoperatively, the SE was +0.20±0.61 D (range, –0.50 acceptable efficacy for corrections up to +4.00 D, but
to +1.50 D). Eight out of 10 eyes (80%) were within limited predictability for higher dioptric corrections,
±0.50 D of emmetropia, 9 eyes (90%) were within and a modest hyperopic regression of about 0.50 D
±1.00 D. There were no complications reported, with all during follow-up4,9. In the present study we observed
eyes seeing 20/40 or better UDVA. In 2002, as part of better results of predictability with the bioptics
the U.S FDA Phase III clinical trial, Bloomenstein et al20 approach when compared with similar studies using
reported on 20 eyes, (preoperative SE of +5.55 D), and hyperopic PRK or LASIK. This may be explained by
postoperatively, the mean SE was +0.06, with more than the fact that to calculate the power of the phakic IOL
80% of the eyes having an uncorrected visual acuity of to be implanted, we considered only the spherical part
20/40 or better. Recently Pesando et al18 reported the of the refraction with the cylinder in negative sign, as
results of a 10-year follow-up study on 59 eyes of 34 astigmatism was corrected by laser in a second step.
patients with hyperopia who had implantation of an Doing this, after phakic IOL implantation, most eyes
ICL. Preoperatively, the mean SE was +5.78± 2.54 D in this study presented myopic or mixed astigmatism
(range +2.50 to +11.75 D). At 10 years, the mean SE that was corrected by myopic LASIK/PRK, which is
was +0.0±0.54 D; it was within ±0.50 D in 81% of eyes, superior to hyperopic LASIK/PRK in efficacy and pre-
within ±1.00 D in 96%, and within ±1.50 D in 100% dictability as well as having a perfect centration that is
and 86.5% had a change in SE refraction within also even more critical in hyperopic LASIK30,31.
±0.50 D during follow-up. The CDVA was reduced by Increased intraocular pressure, pupillary block, and
1 Snellen line in 8.3% of eyes and the UCVA was 20/20 cataract formation, have been the most documented
or better in 49.8% of eyes, 20/40 or better in 87.6%, safety concerns related to ICL implantation32.
and 20/70 in 100%. In the present study, we obtained Allegedly, the risk is higher in hyperopic eyes than in
similar results following ICL implantation; a significant myopic eyes because of the more crowed anterior seg-
reduction in the manifest refractive sphere, nearly ments. However, the incidence rate seems to be lower
emmetropia and a reduction of about 0.57 D in astig- in hyperopic ICLs18,32. In the present study, there were
matism that may be explained by the change in corneal no cases of chronic elevated postoperative IOP or
astigmatism surgically induced after ICL implantation27. cataract development. Furthermore, LASIK and PRK
In the present study we observed that after ICL did not cause dislocation or decentration of the ICL
implantation, 17 (27.4%) eyes lost at least 1 line of and there was no dehiscence of the ICL incision.


The goal of refractive surgery is to achieve (ICL) for moderate to high myopia: three-year follow-up.
emmetropia trough any corrective procedure and there- Ophthalmology 2004; 111: 1683-92.
16. Alfonso JF, Palacios A, Montes-Mico R. Myopic phakic
fore the existence of toric IOLs became a need33. STAAR collamer posterior chamber intraocular lenses for ker-
However, while hyperopic toric ICLs are not available, atoconus. J Refract Surg 2008; 24: 867-74.
bioptics using the hyperopic ICL followed by LASIK or 17. Sanders DR, Martin RG, Brown DC, et al. Posterior chamber
PRK offers a safe and effective method for correcting phakic intraocular lens for hyperopia. J Refract Surg 1999; 15:
moderate to high hyperopia with or without astigmatism. 309-15.
18. Pesando PM, Ghiringhello MP, Di MG, Fanton G. Posterior
Bioptics reduced preoperative spherical and astigmatic chamber phakic intraocular lens (ICL) for hyperopia: ten-year
errors with high predictability and safety. However, more follow-up. J Cataract Refract Surg 2007; 33: 1579-84.
time and investigation are needed to draw conclusions 19. Davidorf JM, Zaldivar R, Oscherow S. Posterior chamber pha-
about the mechanisms of cataract formation and refrac- kic intraocular lens for hyperopia of +4 to +11 diopters. J
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20. Bloomenstein MR, Dulaney DD, Barnet RW, Perkins SA.
Posterior chamber phakic intraocular lens for moderate
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15. Sanders DR, Doney K, Poco M. United States Food and Drug
Administration clinical trial of the Implantable Collamer Lens


ARTICLE

Toric collagen copolymer phakic intraocular
lens to correct myopic astigmatism
in eyes with pellucid marginal degeneration
Gerardo D. Camoriano, MD, Muhammad Aman-Ullah, MD, Mona K. Purba, OD,
Julia Sun, BSc, Howard V. Gimbel, MD, MPH

PURPOSE: To evaluate the clinical outcomes of implantation of the Implantable Collamer Lens
collagen copolymer toric phakic intraocular lens (pIOL) to correct myopic astigmatism in eyes
with mild pellucid marginal degeneration (PMD).
SETTING: Gimbel Eye Centre, Calgary, Alberta, Canada.
DESIGN: Retrospective chart review.
METHODS: All consecutive cases with PMD that had implantation of the toric pIOL from January 1,
2003, to May 30, 2011, were retrospectively reviewed for postoperative outcomes. Perioperative
variables of interest included uncorrected (UDVA) and corrected (CDVA) distance visual acuities,
manifest refraction, and corneal topography.
RESULTS: The study comprised 10 eyes of 5 patients. The mean age was 37.4 years G 2.6 (SEM).
The mean CDVA was 0 G 0.03 logMAR (20/20) preoperatively and À0.04 G 0.03 logMAR (20/18)
postoperatively. The mean postoperative UDVA was C0.14 G 0.05 logMAR (20/28). The mean
spherical equivalent (SE) was À6.71 G 0.9 diopters (D) preoperatively and À0.58 G 0.1 D at
the last follow-up. All eyes had improved CDVA after surgery. One patient reported severe glare
and halos in 1 eye postoperatively, requiring removal and replacement of the toric pIOL because
of a hyperopic refractive surprise. The new toric pIOL was subsequently repositioned because
of high residual astigmatism related to changes in corneal topography postoperatively and
a small shift in the position of the toric pIOL. The final manifest refraction for this eye was
plano À1.00 Â 160.
CONCLUSIONS: Implantation of the collagen copolymer toric pIOL was a safe, effective surgical
procedure for the correction of myopic astigmatism in eyes with mild PMD.
Financial Disclosure: No author has a financial or proprietary interest in any material or method
mentioned.
J Cataract Refract Surg 2012; 38:256–261 Q 2012 ASCRS and ESCRS

At present, several options for the visual rehabilitation devices fail to comfortably or adequately correct
of patients with pellucid marginal degeneration vision, PMD patients may benefit from surgical
(PMD) are available. Usually, a graded approach to approaches. These have included implantation of
treatment is taken, starting with the least invasive intrastromal corneal ring segments,3,4 crescentic
means of vision correction the patient can tolerate. wedge resection,5 crescentic lamellar keratoplasty,6
Spectacles and soft toric contact lenses may work central penetrating keratoplasty (PKP),7 oversized
initially; however, as the condition progresses, they central PKP,8 and inferiorly decentered PKP.7,9 More
may fail to provide the patient with adequate vision. recently, corneal collagen crosslinking (CXL) with
Rigid gas-permeable (RGP) contact lenses are another riboflavin and ultraviolet light has shown promise in
option; however, some patients experience discomfort stabilizing the pathology of PMD and improving
wearing them.1 In addition, because of the peripheral keratometric astigmatism.10,11
thinning of the cornea, patients with PMD are notori- The toric Implantable Collamer Lens collagen copol-
ously difficult to fit with contact lenses.2 When optical ymer phakic intraocular lens (pIOL) (Staar Surgical

256 Q 2012 ASCRS and ESCRS 0886-3350/$ - see front matter
Published by Elsevier Inc. doi:10.1016/j.jcrs.2011.08.040

TORIC PIOL FOR MYOPIC ASTIGMATISM IN PMD 257

Co.) has been used to safely and reliably correct of PMD was based on these data, analysis of corneal topog-
moderate to high myopia and astigmatism.12–16 Given raphy indices by the Corneal Navigator feature of the OPD
Scan II, and clinical judgment. All patients had a high index
that the progression of corneal thinning and ectasia in
of suspicion (above 90%) for PMD as indicated by the
PMD, like keratoconus, tends to stabilize in the third or Corneal Navigator. Figure 1 shows the corneal topography
fourth decade of life,17 toric pIOL implantation may be of 1 patient.
another option for the surgical correction of myopic
astigmatism in this setting. Studies18–20 are beginning
Surgical Technique
to show the safety and efficacy of this treatment
modality in keratoconus. To our knowledge, there is All eyes had implantation of an Implantable Collamer
Lens toric pIOL, which is currently approved in Canada
only 1 case report of a patient with PMD who derived for the correction of myopia between À4.00 D and
benefit from toric pIOL implantation.21 This retrospec- À20.00 D and astigmatism between 1.00 D and 4.00 D. Before
tive case series evaluated patients with myopic surgery, all patients had 2 neodymium:YAG peripheral
astigmatism secondary to PMD who had implantation iridotomies in each eye to prevent pupillary block glaucoma.
of the toric pIOL. The horizontal meridian was marked preoperatively at the
slitlamp to account for posture-related ocular cyclotorsion.
Topical anesthesia of bupivacaine (Marcaine 0.75%) was
PATIENTS AND METHODS administered, and the eye was prepared and draped in the
All consecutive cases with PMD that had implantation of standard sterile fashion. Two limbal paracenteses were
the toric pIOL by the same surgeon (H.V.G.) from January created at 6 o’clock and 12 o’clock. Intracameral
1, 2002, to May 30, 2011, were retrospectively reviewed for preservative-free lidocaine 1.00% was injected, and the
postoperative outcomes. Most patients initially presented anterior chamber was filled with hydroxypropyl methylcel-
for consultation regarding corneal refractive surgery due lulose (Ocucoat). A temporal clear corneal incision was
to contact lens intolerance. Eligibility for toric pIOL implan- created with a 2.75 mm diamond keratome blade (Alcon
tation was determined on an individual basis. Stability in Laboratories, Inc.).
the manifest refraction (within G0.50 diopter [D]) in the Next, the toric pIOL was implanted in the eye using an
year before surgery was required. Exclusion criteria in- MSI-TR injector (Staar Surgical Co.) and allowed to unfold.
cluded previous ocular surgery, trauma, amblyopia, ante- The haptics were gently maneuvered into the ciliary sulcus
rior segment pathology other than PMD, posterior using 2 Pallikaris manipulators (Duckworth & Kent Ltd.)
segment pathology other than myopia, and anterior cham- in a hand-over-hand technique. The toric pIOL was gently
ber depth (ACD) less than 2.70 mm. Informed consent rotated into the orientation specified by the manufacturer
was obtained after detailed discussion of all relevant risks, to correct the astigmatism. The 11 o’clock peripheral iridoto-
benefits, and alternatives of the procedure. In particular, my was entered and stretched with a Pallikaris manipulator
patients were informed about the paucity of literature to confirm patency. After the ophthalmic viscosurgical
regarding the use of the toric pIOL in patients with PMD. device was irrigated from the anterior chamber, care was
After surgery, patients were invited to complete a short taken to ensure that the orientation of the toric pIOL had
survey detailing the quality of their distance and night not shifted.
vision; the presence of glare, halos, image ghosting, or Stromal hydration was performed to achieve wound
double vision; other symptoms; and overall satisfaction integrity, and a small bolus of intracameral vancomycin
with the procedure. (1 mg in 0.1 mL of sterile balanced salt solution) was admin-
istered through 1 of the paracenteses. At the end of the
surgery, a drop of apraclonidine 0.5% (Iopidine) and 2 drops
Preoperative Evaluation of ofloxacin (Ocuflox) were given. The same surgical proto-
All eyes had a comprehensive preoperative ophthalmic col was followed in the fellow eye on the same day or 1 or
examination that included corrected distance visual acuity 2 days later.
(CDVA), manifest refraction by autorefraction (Canon,
RK-F1), keratometry, ACD, corneal topography by OPD
Postoperative Evaluation
Scan II (ARK 10000, Nidek Co. Ltd.) and Orbscan IIz (Bausch
& Lomb), and axial length by partial coherence interferome- All eyes were examined postoperatively at 1 day, 1 week,
try (IOLMaster, version 5, Carl Zeiss Meditec AG). Diagnosis and 1, 3, and 6 months. The examinations included UDVA,
CDVA, manifest refraction, intraocular pressure, and pIOL
vaulting. Outcome measures were recorded at the last post-
Submitted: June 6, 2011. operative visit and included UDVA, CDVA, manifest refrac-
Final revision submitted: August 12, 2011. tion, and corneal topography performed using the same
Accepted: August 14, 2011. devices as preoperatively.

From Gimbel Eye Centre (Camoriano, Aman-Ullah, Purba, Sun,
Gimbel) and the University of Calgary (Camoriano, Gimbel), Statistical Analysis
Calgary, Alberta, Canada; Loma Linda University (Gimbel), Loma The mean and standard error of the mean (SEM) were
Linda, California, USA. calculated for the following variables: age, preoperative
CDVA (expressed as the logMAR), postoperative CDVA,
Corresponding author: Howard V. Gimbel, MD, MPH, Gimbel Eye preoperative spherical equivalent (SE), postoperative SE,
Centre, 450, 4935 - 40 Avenue Northwest, Calgary, Alberta T3A and postoperative UDVA. Histograms showing the percent-
2N1, Canada. E-mail: cgy-info@gimbel.com. age of patients achieving a particular level of UDVA, change

J CATARACT REFRACT SURG - VOL 38, FEBRUARY 2012

258 TORIC PIOL FOR MYOPIC ASTIGMATISM IN PMD

same in 4 eyes (40%), and decreased by 1 line in
1 eye (10%) (Figure 3).
The mean SE in all 10 eyes at the last postoperative
visit was À0.58 G 0.1 D. The SE was within G0.50 D of
plano in 7 eyes (70%), within G1.00 D of plano in 9
eyes (90%), and within G1.50 D of emmetropia in all
eyes (Figure 4). Figure 5 is a comparison of the preop-
erative and postoperative astigmatism.
No cataract formation or complications resulting
from inappropriate toric pIOL vault occurred.
All 5 patients completed the postoperative survey.
Of these, 4 patients reported improvement to distance
and night vision and were satisfied overall with the
outcomes of the surgery. The remaining patient was
not satisfied because of severe glare, halos, and ghost-
ing in 1 eye. These symptoms occurred in the eye with
the less advanced PMD. The patient had a preoperative
refraction of À5.75 À2.50 Â 95 in the affected eye, and
the plan was for a residual refractive error of À0.08 D
Figure 1. Corneal topography of a patient with PMD. after surgery. Instead, the patient had a refractive
surprise of C1.75 À1.50 Â 40, which remained stable
in CDVA, and deviation from emmetropia were created after 6 months. She then had removal and replacement
using Excel 2002 software (Microsoft Corp.).
of the toric pIOL because rotation of the pIOL would
not have changed the hyperopic SE. The postoperative
RESULTS refraction with the new toric pIOL was C1.25 À2.75 Â 38
This study evaluated 10 eyes of 5 patients with mild despite the orientation of the toric pIOL being 2 degrees
PMD. The mean age of the 3 men (60%) and 2 women counterclockwise, within G7 degrees of the manufac-
(40%) was 37.4 G 2.6 years. Table 1 shows the preop- turer’s recommended orientation of 5 degrees clock-
erative and postoperative patient data. wise. Upon repeat testing, it was determined that the
The mean CDVA was 0.00 G 0.03 logMAR (20/20) mean keratometry (measured by the same instrument)
preoperatively and À0.04 G 0.03 logMAR (20/18) had steepened by 0.44 D and the steep corneal axis had
postoperatively. The mean postoperative UDVA was rotated 12 degrees clockwise compared with preoper-
C0.14 G 0.05 logMAR (20/28). The postoperative atively. After vector analysis of the postoperative re-
UDVA was 20/20 or better in 4 eyes (40%) and fraction, the toric pIOL was rotated 26 degrees
20/40 or better in all eyes (Figure 2). The postoperative clockwise, after which the manifest refraction was
CDVA improved by 2 Snellen lines in 1 eye (10%), plano À0.50 Â 7 and the UDVA was 20/15À1; the
improved by 1 line in 4 eyes (40%), remained the patient remains satisfied with her vision.

Table 1. Preoperative and postoperative patient data.

Preoperative Postoperative

Pt Age (Y) Eye Sex Refraction CDVA Refraction UDVA CDVA FU (Mo)

1 48 R M À0.75 À3.50 Â 96 20/20 0.00 À0.50 Â 22 20/20 20/15 23
1 48 L M C0.75 À6.75 Â 89 20/25 C0.50 À2.00 Â 81 20/30 20/15 23
2 38 R F À5.75 À2.50 Â 95 20/15 0.00 À0.50 Â 7 20/15 20/15 24
2 38 L F À1.00 À5.50 Â 95 20/20 À0.25 À1.00 Â 95 20/40 20/20 24
3 39 R F À6.50 À4.50 Â 76 20/25 À1.00 À0.75 Â 14 20/40 20/20 33
3 39 L F À3.50 À4.75 Â 98 20/20 0.00 À1.00 Â 147 20/30 20/20 33
4 24 R M À6.50 À4.00 Â 77 20/20 0.00 À0.75 Â 150 20/20 20/15 70
4 24 L M À6.75 À3.75 Â 96 20/15 0.00 À0.75 Â 25 20/20 20/15 70
5 38 R M À7.25 À4.25 Â 64 20/20 À0.75 sphere 20/40 20/20 26
5 38 L M À7.75 À4.75 Â 121 20/25 0.00 À1.00 Â 107 20/40 20/30 26

CDVA Z corrected distance visual acuity; FU Z follow-up; Pt Z patient; UDVA Z uncorrected distance visual acuity



Figure 2. Postoperative UDVA. Figure 3. Change in CDVA.

DISCUSSION transplantation, which is compounded by the issues
The management of refractive errors in cases of mod- of graft rejection and suture management.7,9 Another
erate or advanced PMD is challenging. The highly recently advocated strategy for the treatment of
irregular against-the-rule astigmatism of PMD is PMD is corneal CXL. This technique has been success-
usually not amenable to spectacle correction with fully used to decrease keratometric astigmatism, stabi-
spherocylindrical lenses.17 Although RGP contact lize corneal ectasia, and improve vision in keratoconus
lenses are another alternative, they must often be over- and PMD patients. However, as with the other previ-
sized to overcome the peripheral corneal thinning and ously described surgical techniques, patients with
steepening, leading to decreased comfort.1,2 Intrastro- moderate to advanced PMD still need RGP contact
mal corneal ring segments have been used with some lenses after the procedure.10,11,23 Hence, it would be
success in PMD cases; however, most studies found beneficial for PMD patients who cannot tolerate con-
marginal improvement in UDVA, especially in cases tact lenses to have access to a technology that most ac-
with high preoperative cylinder.22 Although this curately and reliably corrects myopic astigmatism,
modality of vision correction has been better evaluated allowing the best possible uncorrected visual acuity.
in keratoconus patients, the long-term effects of this Toric Implantable Collamer Lens pIOLs have been
technology in PMD are less understood.4,22 Crescentic validated in many studies as safe and effective for
wedge resection or lamellar keratoplasty may help the correction of moderate to high myopic astigma-
flatten the steep axis; however, significant astigmatism tism.12–16 Randomized prospective comparisons
usually remains after the procedure.5,6 Residual between toric pIOL implantation and excimer laser
astigmatism also poses a problem for corneal vision correction24,25 show better safety, predictability,

Figure 4. Postoperative deviation from emmetropia. Figure 5. Comparison of mean preoperative and postoperative astig-
matism (SE Z spherical equivalent).


260 TORIC PIOL FOR MYOPIC ASTIGMATISM IN PMD

and stability profiles with pIOLs. Based on these stud- 2. Kompella VB, Aasuri MK, Rao GM. Management of pellucid
ies, surgeons are now using toric pIOLs to successfully marginal corneal degeneration with rigid gas permeable contact
lenses. CLAO J 2002; 28:140–145
treat myopic astigmatism in keratoconus and 3. Kymionis GD, Aslanides IM, Siganos CS, Pallikaris IG. Intacs for
keratoconus-suspect eyes.18–20 In the largest case series early pellucid marginal degeneration. J Cataract Refract Surg
of keratoconic eyes with the toric pIOL (25 eyes),18 the 2004; 30:230–233
mean postoperative SE refraction was 0.32 G 0.6 D at 4. Barbara A, Shehadeh-Masha’our R, Zvi F, Garzozi HJ. Manage-
1 year, with 84% of cases being within G0.50 D of ment of pellucid marginal degeneration with intracorneal ring
segments. J Refract Surg 2005; 21:296–298
emmetropia. The mean postoperative UDVA and 5. MacLean H, Robinson L, Wechsler A. Long-term results of
CDVA were 0.17 G 0.6 (20/30) and 0.12 G 0.1 logMAR corneal wedge excision for pellucid marginal degeneration.
(20/25), respectively. The results are similar in our case Eye 1997; 11:613–617. Available at: http://www.nature.com/
series, in which we found toric pIOL implantation to eye/journal/v11/n5/pdf/eye1997164a.pdf. Accessed September
be efficacious and safe for the correction of myopic 9, 2011
6. Cameron JA. Results of lamellar crescentic resection for pellucid
astigmatism in eyes with PMD. marginal degeneration. Am J Ophthalmol 1992; 113:296–302
In our postoperative survey, 1 patient was dissatis- 7. Varley GA, Macsai MS, Krachmer JH. The results of penetrating
fied with the quality of vision in the eye with the less keratoplasty for pellucid marginal corneal degeneration. Am
advanced PMD. This patient had removal and replace- J Ophthalmol 1990; 110:149–152
ment of the toric pIOL due to a hyperopic refractive 8. Skeens HM, Holland EJ. Large-diameter penetrating kerato-
plasty: indications and outcomes. Cornea 2010; 29:296–301
surprise. This was followed by repositioning of the 9. Rasheed K, Rabinowitz YS. Surgical treatment of advanced
new toric pIOL due to high residual astigmatism pellucid marginal degeneration. Ophthalmology 2000; 107:
(a combination of a postoperative change in the 1836–1840
corneal topography and slight shift in the position of 10. Spadea L. Corneal collagen cross-linking with riboflavin and
the toric pIOL postoperatively). This case underscores UVA irradiation in pellucid marginal degeneration. J Refract
Surg 2010; 26:375–377
the challenges involved in high-cylinder corrections. 11. Snibson GR. Collagen cross-linking: a new paradigm in corneal
These include corneal irregularity with higher-order disease – a review. Clin Exp Ophthalmol 2010; 38:141–153
astigmatism; cases in which the vertex of the toric 12. Qasem Q, Kirwan C, O’Keefe M. 5-year prospective follow-up
pIOL does match the vertex of the corneal cylinder; of Artisan phakic intraocular lenses for the correction of myopia,
facial asymmetry, which presents challenges in mea- hyperopia and astigmatism. Ophthalmologica 2010; 224:283–290
13. Hashem AN, El Danasoury AM, Anwar HM. Axis alignment and
suring and marking the meridians with a consistent rotational stability after implantation of the toric implantable
facial orientation; and slight rotation of the toric collamer lens for myopic astigmatism. J Refract Surg 2009;
pIOL from its original position, all of which may 25:S939–S943
play important roles in the final refractive outcome.
14. Dick HB, Alio J, Bianchetti M, Budo C, Christiaans BJ,
€
El-Danasoury MA, Guell JL, Krumeich J, Landesz M, Loureiro F,
A concern about toric pIOL implantation in patients
Luyten GPM, Marinho A, Rahhal MS, Schwenn O, Spirig R,
with PMD is the progression of ectasia and astigma- Thomann U, Venter J. Toric phakic intraocular lens; European
tism after the procedure. In PMD, this usually happens multicenter study. Ophthalmology 2003; 110:150–162
in the third and fourth decades of life.17 Hence, careful 15. Chang J, Lau S. Toric Implantable Collamer Lens for high
patient selection is important to ensure stability of the myopic astigmatic Asian eyes. Ophthalmology 2009;
corneal topography before surgery. However, in cases 116:2340–2347
16. Huang D, Schallhorn SC, Sugar A, Farjo AA, Majmudar PA,
of contact lens intolerance, toric pIOL implantation Trattler WB, Tanzer DJ. Phakic intraocular lens implantation
may be justified in patients with active PMD. In this for the correction of myopia; a report by the American Academy
setting, this procedure debulks the astigmatism to of Ophthalmology (Ophthalmic Technology Assessment).
a level at which spectacles may provide acceptable Ophthalmology 2009; 116:2244–2258
vision. Moreover, although not ideal, the reversibility 17. Sridhar MS, Mahesh S, Bansal AK, Nutheti R, Rao GN. Pellucid
marginal corneal degeneration. Ophthalmology 2004;
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18. Alfonso JF, Palacios A, Montes-Mico R. Myopic phakic STAAR
isfied patient with a hyperopic refractive surprise. collamer posterior chamber intraocular lenses for keratoconus.
J Refract Surg 2008; 24:867–874
19. Venter J. Artisan phakic intraocular lens in patients with kerato-
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nus (CLEK) study. Optom Vis Sci 2004; 81:182–188. Available toric phakic intraocular lens implantation for high myopic astig-
at: https://vrcc.wustl.edu/clekarchive/pdf/20%20Edrington% matism in eyes with pellucid marginal degeneration. J Cataract
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Coskunseven E, Pascual I. Refractive and corneal aberrometric Art. No.CD 007679. Abstract available at: http://onlinelibrary.
changes after intracorneal ring implantation in corneas with wiley.com/doi/10.1002/14651858.CD007679.pub2/pdf/abstract.
pellucid marginal degeneration. Ophthalmology 2009; 116: Accessed September 9, 2011
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results of riboflavin ultraviolet A corneal collagen cross-linking
for keratoconus in Italy: the Siena Eye Cross Study. Am First author:
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25. Barsam A, Allan BDS. Excimer laser refractive surgery versus
phakic intraocular lenses for the correction of moderate to


ARTICLE

Axial length measurement in eyes implanted with phakic
posterior chamber intraocular lenses
Daniel Elies, MD1; José Alfonso, MD; José Güell1,2,3, MD; Oscar Gris, MD1

ABSTRACT: Purpose: To determine where eye length measurements obtained with an
optical biometer before and after Implantable Collamer Lens (ICL) implantation would
show any change.
METHODS: We have analyzed a prospective study a sample of 32 eyes of 19 consecutive
patients implanted with an ICL (Staar Surgical, CA). Spherical equivalent refraction
ranged from –5.50 to –21 diopters (D) (mean –13.73±4.48 D). Axial length was measured
using the IOL Master® (Carl Zeiss, Jena, Germany) non-contact optical biometer before
and after ICL implantation.
RESULTS: Mean axial length value was 27.28±2.05 mm (ranging from 24.43 to
33.36 mm) and 27.31±1.98 mm (ranging from 24.56 to 32.76 mm), before and after the
surgery, respectively. Mean axial length difference between both values was –0.03±0.12
(ranging from –0.17 to 0.10 mm). The paired t-test revealed no statistically significant dif-
ferences in axial length between before and after ICL implantation (P=0.1653). Both meas-
urements correlated in a highly positive manner (R = 0.99, P 0.0001).
CONCLUSION: This study shows that axial length measurement before ICL implanta-
tion is comparable to measurements carried out after surgery. Optical biometry achieves
valid and reliable axial length measurements in eyes implanted with ICL.
KEYWORDS: Axial length, ICL, optical biometry.
J Emmetropia 2011; 2: 9-11

INTRODUCTION Considering the increasing number of implants for
this phakic intraocular lens, the question arises whether
Implantation of a posterior chamber phakic intraoc-
this lens will affect the results of axial length measure-
ular lens for the surgical correction of myopia has been
ment. We need to consider that the speed of sound
proved to be a safe procedure with regard to visual and
through the various materials of phakic lenses, in gener-
refractive results1-9. Recent multicenter clinical studies
al, is widely different and is different from the average
of the United States Food and Drug Administration
velocity used to measure the eye. Then, differences
(FDA) for the STAAR myopic Implantable Collamer
between axial length estimation may happen if this meas-
Lens (ICL, STAAR Surgical, Monrovia, CA) demon-
urement is done before or after ICL implantation. It is
strated the safety and effectiveness of this lens in the
obvious that an accurate biometry is necessary to calcu-
treatment of moderate to high myopia2,3,5,6,9. In addi-
late the power of any intraocular lens for cataract surgery,
tion, recent published outcomes from the clinical FDA
and becomes highly relevant when a phakic intraocular
toric ICL clinical trial10 and other studies11-15 showed
lens is implanted in the cataractous eye. Then, the pur-
also good efficacy and predictability for this lens.
pose of this study is to analyze if there is any change in
the axial length measurement before and after a myopic
Submitted: 11/23/2010 or toric ICL implantation using optical biometry.
Accepted: 12/22/2010
1 Especialista en Catarata y Cirugía Refractiva. Instituto de PATIENTS AND METHODS
Microcirugia Ocular (IMO), Barcelona, Spain.
2 Associate professor of Ophthalmology at Universitat Autonoma All patients included in this non-randomized,
de Barcelona, Barcelona, Spain prospective study underwent a myopic or a toric ICL
3 Director of the Cornea and Refractive Surgery Unit, Instituto implantation at the Instituto de Microcirugía Ocular,
Microcirugia Ocular, Barcelona, Spain.
Barcelona or at the Fernández-Vega Ophthalmological
Address: Daniel Elíes, MD. E-mail: danielies@hotmail.com Institute, Oviedo (Spain) between November 2009 and
© 2010 SECOIR ISSN: 2171-4703 9
Sociedad Española de Cirugía Ocular Implanto-Refractiva

10 AXIAL LENGTH MEASUREMENT IN EYES WITH pIOL

July 2010. Surgery was performed by two surgeons software, STAAR Surgical, Monrovia, CA), with a tar-
(DEA and JFA) after a written informed consent was get refraction of emmetropia in all cases. The ICMV4
obtained. The eyes included in this study had primary and TICMV4 models were implanted in these eyes.
myopia and astigmatism with no previous surgery and All patients underwent pre- and postoperative axial
no abnormal findings diagnosed in the preoperative length measurement using the IOL Master non-con-
ophthalmologic examination. All patients were inap- tact optical biometer (Carl Zeiss, Jena, Germany). The
propriate for other methods of refractive correction due IOL Master® optical biometer uses partial coherence
to one of the following exclusion criteria: insufficient interferometry with a 780 mm laser diode infrared
corneal thickness for excimer ablation or light to measure axial length. The measurement process
abnormal/irregular corneas. Patients with endothelial using this system is fast and the non-contact character
cell counts less than 2200 cells/mm2, anterior chamber of the method reduces the risk of infection and avoids
depth (ACD) from the endothelium less than 2.8 mm, corneal compression hence improving axial length
abnormal iris or other eye diseases were excluded. accuracy. Partial coherence interferometry has been
Patients were enrolled with baseline errors between shown to have the same accuracy as immersion biome-
–5.50 to –21.00 D of myopia (sphere) and 3.00 or try16-19. The measurement of the axial length was done
5.00 D of astigmatism (cylinder). All patients present- preoperative and at one month after the surgery.
ed a stable refraction for 12 months before study Data analysis was performed using SPSS for
enrollment with a best-spectacle corrected visual acuity Windows version 16.0 (SPSS Inc., Chicago, IL).
(BCVA) of at least 20/25 in the study eye. All patients Normality was checked by the Shapiro-Wilk test, and
enrolled in the study were between 22 and 44 years old. the t-test was performed to compare pre- and post-sur-
The Staar ICL is a Collamer (collagen-copolymer), gery outcomes. Differences were considered to be sta-
biocompatible, UV-absorbing, foldable lens with a tistically significant when the P value was 0.05 (i.e., at
refractive index 1.45 at 35°C. This lens is designed to the 5% level).
correct myopia between –3 to –23 D and astigmatism
(if toric) between +1 to +6 D with powers in half-
RESULTS
diopter increments. The lens has an optical diameter
from 4.65 to 5.5 mm and available lengths from 11.5 Thirty-two eyes of 19 consecutive patients (10
to 13.0 mm. To determine the appropriate size of the males and 9 females) implanted with the ICL were
lens, the white-to-white distance was evaluated with an included in this study. Spherical equivalent refraction
Orbscan II (BauschLomb, Rochester, NY) and the ranged from –5.50 to –21 D (mean –13.73±4.48 D).
ACD distance using both an Orbscan II and an anteri- The mean preoperative BCVA was 0.90±0.07 (Snellen
or segment OCT (Visante, CarL Zeiss-Meditec, Gena, decimal visual acuity, ranging from 0.80 to 1.0), the
Germany). The appropriate lens power was determined mean spherical ICL power was –13.53±4.37 D (rang-
with a proprietary software program (ICL calculating ing from –5.50 to –21.00 D) and the mean cylinder
was –4.17±1.04 D (ranging from 0 to + 5.00 D). Mean
implanted ICL size was 12.41±0.34 mm (ranging from
12.00 to 13.00 mm).
Mean axial length value was 27.28±2.05 mm (rang-
ing from 24.43 to 33.36 mm) and 27.31±1.98 mm
(ranging from 24.56 to 32.76 mm), before and after
the surgery, respectively. Mean axial length difference
between both values was –0.03±0.12 (ranging from
–0.17 to 0.10 mm). The paired t-test revealed no sta-
tistically significant differences in axial length between
before and after ICL implantation (P = 0.1653). Figure
1 shows the axial length values measured both before
and after ICL implantation. Continuous line repre-
sents the best linear fit showing a high correlation
between values (R = 0.99, P 0.0001).

DISCUSSION
The results found in the present study point out
Figure 1. Axial length measurement before and after ICL implan- that ICL implantation does not affect axial length
tation using the IOL Master optical biometer. Continuous line rep- measurement. We have obtained a mean reduction in
resents the best linear fit (y = 0.96x + 0.99, R = 0.99, P 0.0001). the axial length value of 0.03±0.12 mm after ICL
JOURNAL OF EMMETROPIA - VOL 2, JANUARY-MARCH

AXIAL LENGTH MEASUREMENT IN EYES WITH pIOL 11

implantation, but being no statistically significant 4. Gonvers M, Bornet C, Othenin-Girard P. Implantable contact
(P = 0.1653). Measurements of axial length before and lens for moderate to high myopia: relationship of vaulting to
cataract formation. J Cataract Refract Surg 2003; 29: 918-924.
after the surgery highly correlate as is shown in figure 1. 5. Sanders DR, Doney K, Poco M. United States Food and Drug
Our results, obtained in a sample of 32 eyes, showed Administration clinical trial of the Implantable Collamer Lens
that there were no differences in axial length measure- (ICL) for moderate to high myopia: three-year follow-up.
ment before and after ICL implantation. Ophthalmology 2004; 111: 1683-1692.
Unfortunately, there are no previous studies analyz- 6. Edelhauser HF, Sanders DR, Azar R, Lamielle H; ICL in
Treatment of Myopia Study Group. Corneal endothelial
ing the theoretical effect on axial length measurement assessment after ICL implantation. J Cataract Refract Surg.
using partial coherence interferometry of phakic 2004; 30: 576-583.
intraocular lenses. However, it is interesting to discuss 7. Lackner B, Pieh S, Schmidinger G, et al. Long-term results of
a previous work carried out by Hoffer20 analyzing this implantation of phakic posterior chamber intraocular lenses. J
effect with ultrasound biometry. As we have introduced Cataract Refract Surg 2004; 30: 2269-2276.
8. Pineda-Fernandez A, Jaramillo J, Vargas J, et al. Phakic poste-
the speed of sound through the various materials of rior chamber intraocular lens for high myopia. J Cataract
phakic intraocular lenses is variable and changes with Refract Surg 2004; 30: 2277-2283.
the material (collamer, PMMA, silicone or acrylic) and 9. Sanders DR. Anterior subcapsular opacities and cataracts 5
the power (thickness) of the lens. Ultrasound velocity years after surgery in the visian implantable collamer lens FDA
for collamer material is 1740 m/s and the correction trial. J Refract Surg 2008; 24: 566-570.
10. Sanders DR, Schneider D, Martin R et al. Toric Implantable
value in axial length using ultrasound biometry after a Collamer Lens for moderate to high myopic astigmatism.
collamer ICL implantation is very small, with about Ophthalmology 2007; 114: 54-61.
11% of the lens thickness added to the axial length 11. Alfonso JF, Lisa C, Abdelhamid A, Montés-Micó R, Poo-
measured. Optical biometry may be affected in a simi- López A, Ferrer-Blasco T. Posterior chamber phakic intraocu-
lar way. Then, the expected effect on axial length meas- lar lenses after penetrating keratoplasty. J Cataract Refract
Surg. 2009; 35: 1166-1173.
urement is low in eyes with myopic lenses with very 12. Alfonso JF, Fernández-Vega L, Fernandes P, González-Méijome
thin centers (0.1-0.2 mm). Similarly it would happen JM, Montés-Micó R. Collagen copolymer toric posterior
for toric lenses. Although hyperopic lenses have a chamber phakic intraocular lens for myopic astigmatism: one-
thicker center (0.3-1.0 mm), the expected change for year follow-up. J Cataract Refract Surg. 2010; 36: 568-576.
axial length up to ICL powers of +20 D would be 13. Alfonso JF, Fernández-Vega L, Lisa C, Fernandes P, González-
Méijome JM, Montés-Micó R. Collagen copolymer toric pos-
about 0.1 mm giving an effective error in intraocular terior chamber phakic intraocular lens in eyes with kerato-
lens power calculation about a quarter of diopter. conus. J Cataract Refract Surg. 2010; 36: 906-916.
Then, the effect on axial length of hyperopic ICL is 14. Alfonso JF, Baamonde B, Madrid-Costa D, Fernandes P, Jorge
also minimal being not a concern for a surgeon in a J, Montés-Micó R. Collagen copolymer toric posterior cham-
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implanted with hyperopic ICLs should be performed 15. Elies D, Alonso T, Puig J, Gris O, Güell JL, Coret A. Visian
in order to prove this statement. toric implantable collamer lens for correction of compound
In summary, the present study has confirmed that myopic astigmatism. J Refract Surg. 2010; 26: 251-258.
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measurement after myopic or toric ICL implantation immersion ultrasound biometry and partial coherence inter-
ferometry for intraocular lens calculation according to Haigis.
using partial coherence interferometry (IOL Master® Graefes Arch Clin Exp Ophthalmol 2000; 238: 765-773.
optical biometer). Axial length measurements show a 17. Haigis W. Optical coherence biometry. Dev Ophthalmol
high correlation before and after ICL implantation, 2002; 34: 119-130.
showing that optical biometry is a valid and reliable 18. Packer M, Fine IH, Hoffman RS, Coffman PG, Brown LK.
technique for axial length measurement in eyes Immersion A-scan compared with partial coherence interferome-
try: outcomes analysis. J Cataract Refract Surg. 2002; 28: 239-242.
implanted with ICLs. This application is practical to 19. Narváez J, Cherwek DH, Stulting RD, Waldron R,
measure axial length in eyes implanted with ICLs need- Zimmerman GJ, Wessels IF, Waring GO 3rd. Comparing
ing cataract surgery. immersion ultrasound with partial coherence interferometry
for intraocular lens power calculation. Ophthalmic Surg Lasers
Imaging 2008; 39: 30-34.
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2. Sanders DR, Vukich JA, Doney K, Gaston M. U.S. Food and First author:
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