Dr Canali. Visian lente fachica. Brescia 16maggio 2017. 7 Corso refractive live surgey Fondazione Poliambulanza. Lenti premium e femtolasik.

5. I-CARE (Corneal)
AcrySof Cachet
(Alcon Inc)
Monopezzo, idrofila in
materiale acrilico con quattro
aptiche. Il diametro dell'ottica è
5.75 mm con un diametro
complessivo da 12 mm a 13,5
millimetri
Monopezzo pieghevole, idrofoba in
materiale acrilico, con diametro dell'ottica di
6,0 millimetri, lunghezza complessiva da
12,5 a 14,0 mm. Le anse sono progettate per
consentire la stabilità lente senza creare una
forza eccessiva che potrebbe causare danni
ai tessuti angolari o ovalizzazione pupillare.
Introdotta in camera anteriore con un
iniettore. Non è necessaria iridectomia

6. Worst nel 1978 ideò l’iris-claw o "lobsterclaw" per la
correzione dell’afachia, una IOL complanare monopezzo
in PMMA che veniva posizionata in camera anteriore
ancorandola in una piega dello stroma medio-periferico
dell’iride (parte meno vascolarizzata e meno reattiva)
Nello stesso anno (1986) in cui Baikoff impiantò la sua
prima lente con ottica biconcava, Fechner in Germania
eseguì l’impianto della prima iris-claw per correggere una
miopia elevata con cristallino in situ

7. Nel 1998 viene commercializzata dalla ditta Ophtec B.V. con il nome di
Artisan, in Europa, e Verisyse negli Stati Uniti. Nel 2003 sono entrate
sul mercato le IOL pieghevoli Artiflex Piol (Ophtec B.V.), Veriflex negli
Stati Uniti con ottica in silicone convesso-concava con diametro di 6
mm, aptiche in PMMA e lunghezza complessiva di 8,5 mm. Il
vantaggio della Artiflex, flessibile rispetto all'Artisan, è la piccola
incisione attraverso cui può essere inserita (3,2 mm), diminuendo
l'astigmatismo indotto chirurgicamente
La lente Artisan è una monopezzo in PMMA con lunghezza totale di
8,5 mm e ottica di 5 o 6 mm di diametro in base al potere

8. Lenti da camera anteriore a fissazione
iridea

9. Nel 1986 Fyodorov impiantava la prima lente fachica
con aptiche in camera posteriore e ottica in campo
pupillare: la “collar button” o lente a fungo
La lente era monopezzo in silicone con
piccola zona ottica (3-4 mm) a
superficie concava, posizionata in
campo pupillare e veniva mantenuta in
sede dai movimenti della pupilla

10. Nel 1990 nasce la prima lente fachica
da camera posteriore (PCP-IOL)
Ottica biconcava con diametro
utile di 4,5 mm, parte aptica piatta
e rettangolare (plate aptic) di 6
mm di larghezza e lunghezza
variabile

11. L’unica lente fachica in silicone ancora in commercio ma in attesa
del FDA approval è la Medennium Phakic Lens (MPL), evoluzione
della Phakic Refractive Lens (PRL-CP - Carl Zeiss Meditec)
Lenti da camera posteriore
In silicone di seconda generazione con indice
refrattivo elevato (n=1.46), superficie
posteriore concava con raggio di 10,0 mm
che imita la curvatura anteriore del
cristallino
Lente pieghevole con minima induzione di astigmatismo. Grazie al
materiale idrofobo non viene a contatto con la capsula anteriore del
cristallino né sviluppa sinechie anteriori

12. Nel 1994 la Staar sviluppa una lente da camera posteriore e
annuncia il primo impianto in Argentina eseguito dal dottor
Zaldivar. In realtà questa fase sa di italiano perché il primo
chirurgo ad impiantare un ICL fu il dottor Pesando nel settembre
del ’93 seguito poche ore dopo dal dottor Assetto e nel
nell’autunno ‘94 dal dott. Caramello
La lente è chiamata ICL (Implantable Collamer Lens)
Visian ICL V4c

13. La ICL è costruita con un materiale detto “Collamer” formato da
0.2% di collagene di origine porcina, 63% di componente acrilica
(idrossietilmetacrilato), 33% di acqua e la restante percentuale da
benzofenone che presenta un’elevatissima biocompatibilità
performance ottica
Nel 2003 l’FDA statunitense approva l’ICL per la correzione
miopica.
Dopo la prima autorizzazione l’FDA richiede un cambiamento del
nome della lente per la tutela del paziente: da Implantable Contact
Lens a Implantable Collamer Lens per evitare che il paziente
ritenesse la procedura non invasiva
Dal 2003 la ICL è la lente fachica più utilizzata

14. • Foldable
• Posterior chamber sulcus-located
• Made of Collamer®: Proprietary material to
STAAR
• State-of-the-art patented technology:
 Manufactured by STAAR
• Wide range of prescriptions
 Myopia, hyperopia, astigmatism (range dependent on
local approvals)
• Excellent quality of vision with many clinical
studies

15. Visian ICL
This material is for ICL proctors
ONLY

16. Current Visian ICL situation
CONFIDENTIAL 16
This material is for ICL proctors ONLY
• Over 650,000 Visian ICLs have been implanted. Over
10,000 of these have been in eyes for 15 years or more.
• Included in these numbers are over 130,000 Toric ICLs
and >200,000 Visian CentraFLOW lenses implanted.
• The Visian ICL is the fastest growing refractive technology
in the world.
• STAAR R&D is working on a pipeline of products including
preloaded ICLs and ICLs that treat presbyopia.

17. Exceptional Patient Satisfaction
2. Sanders D, Schneider D, Martin R, Brown D, Dulaney D, Vukich J, Slade S, Schallhorn S. Toric Implantable Lens for Moderate to High
Myopic Astigmatism. Ophthalmology 2007; 114: 54-61
3. UV-absorbing collamer implantable lens (ICL) for the correction of myopia. PMA# P030016. Presentation to the Ophthalmic Devices
Advisory Panel. October 2003.
This material is for ICL proctors
ONLY

18. • Behind the iris
– Far from the endothelium
– Excellent cosmesis (invisible to the eye)
– Close to the Nodal points of the eye
– Greater effective Optical Zone (at the corneal plane)
• Sulcus located
– Stable location (allows for Toric design with same platform)
– Easy to remove/exchange
– No fixations into tissues (iris)
– Does not alter shape/remove tissue of
the cornea
Posterior Chamber Concept

19. Made of Collamer material
• Collagen & HEMA copolymer
– Excellent biocompatibility -
“quiet eye“
– Excellent transmittance and
low reflectance patterns
– Very flexible (foldable, small incision,
easy to inject and remove)
– YAG friendly
– Easy to lathe: wide range of prescriptions possible
– Best material for a phakic IOL, long-term safety
and tolerance proven
– Available only from STAAR
This material is for ICL proctors
ONLY

20. Collamer Summary
• Hydrophilic: no glare
• Affinity for fibronectin: Biocompatibility
• Refractive index = 1.45
• Elastic: Gentle unfolding
• Tensile strength: Strong, Resists Tearing
• UV Chromophore (covalently bound)
This material is for ICL proctors
ONLY

21. COMPARISON V3 & V4 and MODELS
Includes V4b and V4c models
Design features:
This material is for ICL proctors
ONLY

22. ICL V4 ICL V4B & V4c
11.0 11.6
11.5 12.1
12.0 12.6
12.5 13.2
13.0 13.7
Hy
p
My
op
This material is for ICL proctors ONLY. Not for MDs
Lens Length:
This material is for ICL proctors
ONLY

23. The Design of the Visian ICL CentraFLOW
with KS- Aquaport – The Port
• 360µm port in the center of the
optic.
• Designed to restore more natural
aqueous flow and eliminate the
need for iridotomies.
• 360µm Peri-optic ports are
designed to facilitate OVD removal
and provide redundancy for the
central optic port. V4c model available for the
myopic spheric and myopic toric
lens versions
This material is for ICL proctors
ONLY

24. VICH
VTICH
This material is for ICL proctors
ONLY

25. The images below represent simulation of quality of vision
having equal treatment with the ICL and LASIK based on
higher order aberrometry (-7.0D treatment)
After ICL After LASIK
This material is for ICL proctors
ONLY

26. Visual Performance After Posterior Chamber Phakic Intraocular Lens Implantation
and Wavefront-Guided Laser In Situ Keratomileusis for Low to Moderate Myopia.
Am J Ophthalmol 2012;153:1178 –1186. KAZUTAKA KAMIYA, AKIHITO IGARASHI, KIMIYA SHIMIZU, KAZUHIRO MATSUMURA, AND
MARI KOMATSU
• 30 eyes of 20 patients undergoing ICL implantation and 64 eyes of 38
patients undergoing WFG-LASIK for the correction of low to
moderate myopia (manifest spherical equivalent -3.00 to -5.88 D).
• Ocular higher order aberrations (HOAs) and contrast sensitivity (CS)
function were measured at 4 and 6 mm pupil.
4 mm pupil 6 mm pupil

27. CONCLUSIONS:
ICL implantation appears to induce significantly fewer ocular HOAs than WFG-guided LASIK.
Thus, even in the correction of low to moderate myopia, ICL implantation appears to be
superior in visual performance to WFG-LASIK, suggesting that it may be a viable surgical
option for the treatment of such eyes.
ICL WFG-LASIK

28. Summary of ICL characteristics
• Single piece foldable design
• Behind the iris/sulcus located
• Made of a proprietary material COLLAMER, highly
biocompatible, foldable, with excellent optical properties
• Long-term proven history, optimised to enhance safety and
outcomes
• Wide range of prescriptions: full range of correction from -18 to
+ 10 D with or without astigmatism up to 6 D
• Removable/exchangable
• Excellent Quality of Vision (Untouched cornea and tear film)
with fast visual recovery
• Cannot be seen by casual observer – cosmetically attractive for
patients
This material is for ICL proctors
ONLY

29. ™
™
+
Introduzione a EVO+ Visian ICL
 Il disegno della EVO+ Visian ICL introduce un incremento dell’ottica
portando il diametro del piatto ottico ad un diametro con un range da 5.0
mm a 6.1 mm nelle lenti sferiche con potere da -0.5 D a -14.0 D
inizialmente nel mercato Europeo, seguito da un sistematico lancio nei
mercati internazionali.
 Nel mercato Europeo, EVO+ è stata introdotta con l’obiettivo di aumentare
l'apprezzamento dei pazienti Millennial.
Confidential. Internal Purposes Only. Do Not Distribute.
Enlarged optical zone.
with an overall gain in optical surface
(5.0 mm – 6.1 mm optic diameter depending on Diopter)

30. ™
™
+
Confidential. Internal Purposes Only. Do Not Distribute.
Value Proposition
 EVO+ Visian ICL con il diametro del piatto ottico allargato è disegnata
per aumentare ulteriormente le prestazioni, oramai collaudate,
delle Visian ICL soprattutto per i pazienti con pupilla larga.
 Una superficie allargata di tutta l’area refrattiva con una ottima qualità
ottica è un evidente benefit per i giovani pazienti o per quelli con
pupilla più larga.
 Una correzione refrattiva con zone ottiche più larghe sono auspicabili
perchè riducono la possibilità che la luce possa passare
attraverso aree ottiche non trattate refrattivamente o in aree di
transizione, perché questo determina una qualità visiva più bassa
ed effetti indesiderati quali gelare, halos, o aberrazioni di alto ordine
(HOA).

31. JCRS Article on EVO+ Visian ICL
 JCRS Article1 compared the optical quality (in vitro) of EVO Visian ICL (V4c)
and EVO+ Visian ICL (V5) at 4 different spherical powers and 3.0, 4.5 and 5.5 mm
optical apertures. EVO + lenses were assessed also at largest optical aperture of
6.0 mm.
 RMS of HOAs up to the 7th order, trefoil, coma, tetrafoil, secondary astigmatism,
and spherical aberration showed no statistical differences between models for
any power and optical aperture
 Patients with larger pupil diameters could benefit from the EVO+ Visian ICL
(V5) because the EVO+ Visian ICL (V5) model showed “excellent” in vitro
optical quality with a larger optical diameter than the EVO Visian ICL (V4c)
model.

32. ™
™
+
Confidential. Internal Purposes Only. Do Not Distribute.
EVO and EVO+ Specifications

33. Patients Age Range 21 – 45 years have mean and
maximum pupil diameter under night driving
conditions of 5.4 mm and 5.2 mm, respectively2.
Between a mesopic pupil size and pIOL optic diameter a
possible risk factor for night-vision disturbances exists
such as halos.3
10. Koch DD, Samuelson SW, Haft EA, Merin LM. Pupillary size and
responsiveness; implications for selection of a bifocal intraocular
lens. Ophthalmology 1991; 98:1030–1035
Average Pupil Size by Age Group

34. ™
™
+
Confidential. Internal Purposes Only. Do Not Distribute.
Expanded Optical Zone Comparison
Una zona ottica allargata nelle diottrie <-14.5 mantenendo
lo stesso spessore della lente.
EVO (-14.5 D to -18.0 D)
EVO+ (-0.5 D to -14.0 D)

35. Methods• Retrospective evaluation of safety and efficacy
on patients with hyperopia and myopia
implanted with Implantable Collamer Lens (ICL)
version V4 between 2011 and 2016. Follow up
goes up to 5 years
• Multicentre study involving 5 surgeons from 5
different sites. The sites shared their data in a
cohort of 586 eyes
Doctor ICL Toric ICL hyperopes V4B V4C Total
Cochener 88 114 18 21 169 208
Fournie 13 11 0 6 18 24
Lesueur 15 16 5 8 18 31
Levy 34 172 21 33 152 206
Assouline 47 36 4 22 60 117
586
Number of eyes 586
Age (mean) 37
SEQ -8.59
Anterior Chamber
depth (mm)
3.19
White to White
(mm)
11.84
Intraocular
pressure (mmHg)
14.5
Endothelial Cell
Count
2726

36. Mean uncorrected Visual Acuity (UCVA)
myopes and hyperopes combined
Monocular:
• Stable UCVA: average 0.89
(P>0.05)
• Significant increase in UCVA
between 3 and 4 years (P<0.05)
Binocular:
• Stable UCVA over years:
average 1.01
(P> 0.05)
0.00
0.20
0.40
0.60
0.80
1.00
1.20
1.40
1 yr n=177 2 yrs n=96 3 yrs n=64 4 yrs n=32 5 yrs n=13
Visualacuity
Monocular Binocular

37. Mean Spherical Equivalent (SEQ) myopes and
hyperopes
• Mean SEQ postoperatively: -0.57 D
-2.00
0.00
2.00
4.00
6.00
8.00
preop n=42 1 year n=19 2 years n=8 3 years n=6
Hyperopes
• Mean SEQ postoperatively: 0.30 D
-10.00
-8.00
-6.00
-4.00
-2.00
0.00
2.00
Preop
n=493
1 yr
n=145
2 yrs
n=94
3 yrs
n=59
4 yrs
n=30
5 yrs
n=15
Diopters
Myopes

38. Mean Best Corrected Visual Acuity (BCVA)
myopes and hyperopes
0.00
0.20
0.40
0.60
0.80
1.00
1.20
Preop n=43 1 year n=14 2 years n=7 3 years n=2
Hyperopes
0.00
0.20
0.40
0.60
0.80
1.00
1.20
Preop
n=485
1 yr
n=119
2 yrs
n=86
3 yrs
n=63
4 yrs
n=24
5 yrs
n=16
Visualacuity
Myopes
Slight gain in BCVA from preop (average 0.86) to 5
years after surgery (average 0.92)
BCVA preop average 0.94 and postop average 0.92

39. Change in Best Corrected Visual Acuity (lines)
myopes and hyperopes combined
The average over 5 years
follow up:
• 4% lost one or more lines
• 46% had no change
• 50% gained one or more
lines
0
10
20
30
40
50
60
70
1 year n=128 2 years n=82 3 years n=63 4 years n=29 5 years n=11
Proportionofeyes
Lost one or
more lines
No change
Gained one or
more lines

40. Mean Endothelial Cell Count (ECC) myopes and
hyperopes
Percentage
loss
1 year 2 years 3 years 4 years 5 years
-5.65% 0.20% 2.31% 0.94 1.70
1500
2000
2500
3000
3500
preop n=37 1 year n=37 1 year n=8 2 years n=2
Hyperopes
Percentage
loss
1 year 2 years 3 years 4 years
-3.13% 5.48% -5.73% 3.87%
1500
2000
2500
3000
3500
Preop
n=448
1 yr
n=117
2 yrs
n=72
3 yrs
n=64
4 yrs
n=28
5 yrs
n=14
ECC
Myopes

41. Mean Intraocular Pressure (IOP) myopes and
hyperopes
6
8
10
12
14
16
18
20
Preop
n=353
1 yr
n=161
2 yrs
n=92
3 yrs
n=61
4 yrs
n=37
mmHg
Myopes
• The mean Intraocular pressure is well controlled over time (P>0.05)
6
8
10
12
14
16
18
20
preop
n=18
1 year
n=14
2 years
n=8
3 years
n=4
Hyperopes

42. Cataract
 Only 1 case of cataract has been reported
 A 24 year old patient developed a subcapsular
cataract after one year that required cataract
surgery:
 Patient was preop high myopic: S-16.75 C-3.00
 Patient received an ICL version V4b (without Central Hole)
 13 patients developed asymptomatic subcapsular
opacifications:
 9 patients with ICL version V4b (without Central Hole)
 7 myopes (average SEQ -10.34 D) and 5 hyperopes (average SEQ +6.73 D). Average age 41 years old
 Average time of occurrence: 1.8 years
 Efficacy index: 1.16
 Safety index: 1.24

43. VICMO DFU – example of labeled
complications
• Adverse reactions and complications due to, or following surgery and implantation
of any VTICL may include, but are not limited to: Hyphema, Non-reactive Pupil, Pupillary
• Block, Vault, Additional YAG Iridotomy, Secondary Glaucoma, Cataract, Intraocular
Infection, Uveitis/Iritis, Retinal Detachment, Vitritis, Corneal Edema, Macular Edema,
Corneal Decompensation, Over/Under Correction, Significant glare and/or halos (under
night driving conditions), hypopion, increased astigmatism, loss of BSCVA,
rotation/decentration/subluxation, IOP elevation from baseline (potentially related to
angle closure or from pigment occlusion of the trabecular meshwork or pigment
occlusion of the central hole), corneal endothelial cell loss, severe intraocular
inflammation, secondary surgical intervention to remove/replace the lens, synechia to
implant, Conjunctival Irritation, Vitreous Loss.
Be familiar, read and understand all current DFUs for each model

44. Summary of ICL Complications
• Preop
– Power
– Size
• Intraop
– Wound Construction
– Loading
– Insertion
• Early Postop
– Elevated IOP
– Pupil block / angle closure
– Traumatic cataract
– Over or under-sizing
• Late Postop
– Glare, halo
– Iris transillumination
– cataract (?)
– Glaucoma(?)
• Atypical long-term findings
– Pupil Ovalization
– Iris transillumination
– Pigment on lens

45. ICL optimal vault

46. ICL Sizing

47. Clinically Significant Anterior
Subcapsular Cataract: 1.3% - US FDA
Trial

48. High Vaulting
ICL Sizing