Lente Fachica da da camera posteriore per correzione miopia Dottor Nicola Canali

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

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

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

Lenti da camera anteriore a fissazione iridea

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

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

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

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

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

• 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

Visian ICL

This material is for ICL proctors ONLY

Current Visian ICL situation

CONFIDENTIAL 16


• 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.

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.


• 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

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


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)


COMPARISON V3 & V4 and MODELS

Includes V4b and V4c models

Design features:


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

Hyp

Myop

This material is for ICL proctors ONLY. Not for MDs

Lens Length:


The Design of the Visian ICL CentraFLOWwith 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 versionsThis material is for ICL proctors

ONLY

VICH

VTICH


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 LASIKThis material is for ICL proctors

ONLY

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, ANDMARI 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

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

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


™

™

+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)

™

™

+


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).

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.

™

™

+


EVO and EVO+ Specifications

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

™

™

+


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)

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 Chamberdepth (mm)

3.19

White to White (mm)

11.84

Intraocularpressure (mmHg)

14.5

Endothelial Cell Count

2726

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

Vis

ual

acu

ity

Monocular Binocular

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

Preopn=493

1 yrn=145

2 yrsn=94

3 yrsn=59

4 yrsn=30

5 yrsn=15

Dio

pte

rs

Myopes

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

Preopn=485

1 yrn=119

2 yrsn=86

3 yrsn=63

4 yrsn=24

5 yrsn=16

Vis

ual

acu

ity

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

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

Pro

po

rtio

n o

f ey

es

Lost one ormore linesNo change

Gained one ormore lines

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

Preopn=448

1 yrn=117

2 yrsn=72

3 yrsn=64

4 yrsn=28

5 yrsn=14

ECC

Myopes

Mean Intraocular Pressure (IOP) myopes and hyperopes

6

8

10

12

14

16

18

20

Preopn=353

1 yrn=161

2 yrsn=92

3 yrsn=61

4 yrsn=37

mm

Hg

Myopes

• The mean Intraocular pressure is well controlled over time (P>0.05)

6

8

10

12

14

16

18

20

preopn=18

1 yearn=14

2 yearsn=8

3 yearsn=4

Hyperopes

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 subcapsularopacifications: 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

VICMO DFU – example of labeled complications

• Adverse reactions and complications due to, or following surgery and implantationof any VTICL may include, but are not limited to: Hyphema, Non-reactive Pupil, Pupillary

• Block, Vault, Additional YAG Iridotomy, Secondary Glaucoma, Cataract, IntraocularInfection, Uveitis/Iritis, Retinal Detachment, Vitritis, Corneal Edema, Macular Edema,Corneal Decompensation, Over/Under Correction, Significant glare and/or halos (undernight driving conditions), hypopion, increased astigmatism, loss of BSCVA,rotation/decentration/subluxation, IOP elevation from baseline (potentially related toangle closure or from pigment occlusion of the trabecular meshwork or pigmentocclusion of the central hole), corneal endothelial cell loss, severe intraocularinflammation, secondary surgical intervention to remove/replace the lens, synechia toimplant, Conjunctival Irritation, Vitreous Loss.

Be familiar, read and understand all current DFUs for each model

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

ICL optimal vault

ICL Sizing

Clinically Significant Anterior Subcapsular Cataract: 1.3% - US FDA

Trial

High Vaulting

ICL Sizing

Lente Fachica da da camera posteriore per correzione miopia Dottor Nicola Canali

Health & Medicine

Transcript of Lente Fachica da da camera posteriore per correzione miopia Dottor Nicola Canali