Download ICL Design ICM is Very Thin

8/28/2015
Financial Disclosure:
• Alcon, consultant
Michael S. Petrik, MSc, OD, FAAO
The author has received no financial gain
nor proprietary investment in any of the
companies or products presented today
History of ICL
Implantable Collamer Lens (ICL)
ƒVisian ICL™ (Staar Surgical)
ƒOver 500,000 have been implanted globally
ƒIntraocular lens made of collamer
ƒRemovable/exchangable
ƒVery flexible (easy to inject, easy to explant)
ƒEasy to lathe: wide range of prescriptions
ƒExcellent optical perfomance (HD vision)
ICL Design
ƒ100% Collagen & HEMA
(hydroxyethyl methacrylate) copolymer
i. First ICLs in Western World implanted in 1993:
Roberto Zaldivar (Mendoza, Argentina)
Christian Skorpik (Vienna, Austria)
Paolo Pesando/Vincenso Assetto (Turin, Italy)
ii. ICLM first approved in USA on Dec.26, 2005
iii. In Canada, ICM/ICH approved June 6, 2001
and Toric (TICM) approved June 8, 2005
Howard Gimbel implanted most TICM worldwide
ICM is Very Thin
< 100 um
OPTIC
ƒ Excellent biocompatibility
1) Protein repulsion – negative ionic
charge, reduces protein adherence
2) Shields lens – Collamer attracts fibronectin, a
protein that binds to collagen, which shields it
from autoimmune attack by the body
HAPTIC
≈ 100
microns
FOOTPLATES
500-600 um
ƒ Excellent transmittance and low reflectance
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‘HD Vision’ with ICL
1. Corneal ‘Preservation’ Technique
No corneal remodeling/injury
‘Sparing the cornea’
Nodal Point Optics
Refractive correction sits further to back of the eye
Closer to nodal point = best optical position
PRK (Bowman’s)
2. Minimal Tissue Disruption
Lens NOT sutured to structures
Not removing tissue
3. Nodal Point Optics
Light rays that are not refracted, but
are translated down the optical axis
¾Refractive index 1.45
¾UV Absorbing
(10% transmission)
LASIK
(Stroma)
ICL (sulcus)
Myopic ICM: -3.0 to -20.0 (USA)
-3.0 to -23.0 (CAN)
Hyperopic ICH: +3.0 to +20.0 (CAN)
¾Removable/
Exchangeable
¾Very malleable/foldable
ƒ Corrects cylinder at the individual axis
ƒ Rotate +/- 22 degrees (CW or CCW)
Toric TICM: -3.0 to -23.0 sph
+1.0 to +6.0 cyl (CAN)
1. Diffuse lamellar keratitis
2. Central toxic keraotopathy
3. Epithelial ingrowth
4. Flap disturbance
5. Corneal striae/folds
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*Adults 19 – 45 years of age
*No ocular pathology
*Minimum 8mm dilated pupil (mesopic)
*ACD ≥ 2.8 mm – measured from corneal
endothelium (3.0mm preferred)
*Angle grade VHIII to IV (>30 deg.)
*Min. endothelial cell count
~2500 cells/mm2
*Stable refractive ≤ 0.50 D for 1 year
*Low endothelium cell count <2000 cells/mm2
*Fuchs’ dystrophy or corneal pathology
*Uveitis, pigment dispersion syndrome,
retinal diseases, glaucoma, cataract
*History of intraocular surgery
*Blind in follow eye (amblyopia acceptable)
*Diabetes, pregnant or nursing
*The ‘20/40’ patient/expectations
™ Keratoconus/Forme Fruste
™ Thin corneal thickness
™ Patients at risk for post op ectasia
™ High refractive error in healthy eye
™ Pseudophakia
™ Amblyopia?
Sulcus = depression or furrow
Anterior to
crystalline
lens
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ƒ Placed in the posterior chamber of
the phakic eye (sulcus)
o The corneal endothelium benefits from a
‘shield function’ of the iris.
ƒ Invisible to the eye
ƒ Removable/exchangable
ƒ No fixations into tissues (iris)
ƒ Does not alter shape of the cornea
or remove tissue
WTW
vs
STS
o Endothelium has a regenerative zone in the
peripheral remodels over time.
o Long term functioning of endothelium relies
on the migration/remodeling of these cells.
ƒ OCOS online ordering system
International: Nidau, Switzerland
USA: Monrovia, California
STS
ƒ BSS vs NaCl packaging
‘Swelling’ factor
‰UBM provides a direct measurement of the STS
‰*WTW is the only approved method by FDA
Diameter ICM: 12.1, 12.6, 13.2, 13.7 (BSS)
(mm)
ICM: 11.5, 12.0, 12.5, 13.0 (NaCl)
ICH: 11.0, 11.5, 12.0, 12.5 (NaCl)
¾ Cylinder is set to individual axis
¾ Lens implanted horizontally*
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Sulcus
ƒ
1-2 weeks pre-op
ƒ Must be large & patent:
at least 0.8 to 1 mm
ƒ Location: 10.30 o’clock and
1.30 o’clock, or (90°) apart in
the superior iris
ƒ Inadequate PIs can cause early
post-op complications (IOP
rise, pup. block)
Manual Marking
Horizontal Slit
Live surgical tracking eliminates need
for manual marking!
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180
°
0°
5°
CCW
Diamond shaped marks indicate axial alignment.
Plus axis at labeled if diamond marks at 0-180°.
Plus axis at labeled + CCW rotation
Plus axis at labeled – CW rotation
Surgical Video to be played
“THE
VAULT”
Myopic
Hyperopic
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Degrees of ICL Vaulting
High vault
ICL Low vault
• IOP spike! High IOP low 30s to 40s mmHg
pupillary block/oversized ICL
retained viscoelastic = ‘burp’
• Anterior Subcapsular Cataract
1.3% - US FDA Trial (0.6% significant)
• Glaucoma (pigmentary, pup. block, ↑IOP)
• Min. endothelial cell count
<1500 mm2 = explant
(World explantation rate is 1%)
ƒ
DO NOT dilate with cyclogel (can cause angle
closure), use 1% trop./2.5% phenyl.
ƒ
IOP check: Caution if IOP >24 mmHg or 10
mmHg higher than pre-op
ƒ
IOP Elevation
ƒ Retained Viscoelastic – burp and recheck
ƒ Non-patent Iridotomies – repeat YAG
ƒ
Check PIs for patency
ƒ
Check ICL vault
ƒ Low vault is common first 24 hours
ƒ Intraocular procedure
ƒ Pre-operative work up is more
demanding
ƒ Requires peripheral iridotomy
*New version to eliminate PIs
ƒ Cost $ = 2-4x more expensive than
LASIK/PRK
¾ Treat high, low and astigmatic refractive
errors (outside ranges of LASIK/PRK)
¾ Removable (LASIK/PRK are ‘committed’)
¾ Does not contraindicate future surgical
procedures (cataract surgery)
¾ ICLs outperform LASIK/PRK in acuity and
stability (Sanders and Vukich, 2006)
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Case 1
Case 1
Female, Caucasian, 23 years old, student from Oklahoma
- heavily dependent on spectacles/soft contact lenses
Implanted Toric ICL: OD: TICM125V4 -15.5 -6.00 x007
OS: TICM125V4 -18.0 -5.00 x180
Pre-op Cyclo Refraction:
OD -11.50 -5.25 x010
OS -13.50 -3.75 x175
24 hour post op:
VA: OD: 20/25+1
OS: 20/20-2
IOP: OD: 13mmHg
OS: 13mmHg
Vault: OD: 100%
OS: 100%
3 month post op:
VA: OD: 20/20-2
IOP: OD: 11mmHg
OS: 13mmHg
OS: 20/25Vault: OD: 110%
OS: 110%
Rx OD: +0.25 -0.25 x015 20/20-1
OS: +0.50
20/25+1
20/25-2
20/25-2
VD=13.75mm
Pre-op Keratometry:
OD 45.92@099, 42.99@009
OS 47.27@086, 43.77@176
ACD:
Angles:
CT:
STS :
IOP:
OD 3.17, OS 3.28 (Pentacam)
OD 40.5deg, OS 40.0deg (Pentacam)
OD 526µm, OS 531µm
OD 12.3, OS 12.4 (Sonomed)
OD 15mmHg, OS 13mmHg
Case 2
Case 2
Male, Caucasian, 36 years old, investment advisor, full
time SCL/glasses, not a candidate for PRK/LASIK
Implanted Toric ICL: OD: ICH120V3 +13.00
OS: ICH120V3 +13.00
Pre-op Cyclo Refraction:
OD +7.00
20/20
OS +7.00
20/20
1 week post op:
VA: OD: 20/20-2
OS: 20/25-2
IOP: OD: 14mmHg
OS: 14mmHg
Vault: OD: 100%
OS: 100%
2 year post op:
VA: OD: 20/20
IOP: OD: 13mmHg
OS: 20/25+2
OS: 14mmHg
Vault: OD: 75%
OS: 75%
Rx OD: -0.25 -0.25 x065 20/20
OS: -0.25 -0.50 x180 20/20
VD=13.75mm
Pre-op Keratometry:
OD 41.67@012, 42.29@102
OS 40.27@010, 41.36@100
ACD: OD 3.00, OS 3.00 (Pentacam)
Angles: OD 31.1deg, OS 34.4deg
CT:
OD 537µm, 540µm
STS: OD 11.6, OS 11.6 (Sonomed)
IOP:
OD 12mmHg, OS 12mmHg
Case 3
Case 3
Male, Caucasian, 35 years old, auto technician from WA
state, heavily dependent on spectacles/contacts
Implanted Toric ICL: OD: TICM125V4 -7.50 -6.00 x025
OS: TICM125V4 -6.50 -6.00 x172
Pre-op Cyclo Refraction:
OD -5.00 -4.25 x014 20/20
OS -4.00 -5.25 x174 20/20
24 hour post op:
VA: OD: 20/20OS: 20/20IOP: OD: 14mmHg
OS: 17mmHg
Vault: OD: 75%
OS: 50%
3 months post op:
VA: OD: 20/20
IOP: OD: 16mmHg
OS: 20/20OS: 17mmHg
Vault: OD: 100%
OS: 75%
Rx OD: plano
20/20
OS: pl -0.50 x020 20/20
VD=13.75mm
Pre-op Keratometry:
OD 45.92@102, 42.61@012
OS 45.92@084, 42.13@174
ACD: OD 2.96, OS 3.04 (Pentacam)
Angles: OD 39.7deg, OS 39.2deg
CT:
OD 542µm, 530µm
STS: OD 11.8, OS 12.0 (Sonomed)
IOP:
OD 16mmHg, OS 17mmHg
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Case 4
Case 4
Female, Caucasian, 52 years old, bus driver
- heavily dependent on spectacles, no contacts
- pt at high risk for RD with refractive lensectomy
Implanted Toric ICL: OD: TCIM120V4 -20.0 -1.00 x073
OS: TCIM120V4 -20.0 -3.00 x100
Pre-op Cyclo Refraction:
OD -15.25 -1.25 x075
OS -16.50 -3.25 x102
24 hour post op:
VA: OD: 20/25
OS: 20/70IOP: OD: 14mmHg
OS: 14mmHg
Vault: OD: 40%
OS: 40%
12 month post op:
VA: OD: 20/15-2
IOP: OD: 17mmHg
OS: 15mmHg
OS: 20/40-2
Vault: OD: 50%
OS: 100%
Rx OD: plano -0.50 x180 20/15
OS: -0.25 -1.25 x150 20/25-2
VD=13.75mm
20/20-1
20/50+2 (amblyopic)
Pre-op Keratometry:
OD 46.55@054, 46.17@054
OS 46.81@012, 45.49@102
ACD: OD 2.99, OS 2.93 (Pentacam)
Angles: OD 41.8deg, OS 42.6deg
CT:
OD 535µm, 532µm
STS: OD 11.43, OS 11.37 (Sonomed)
IOP:
OD 16mmHg, OS 16mmHg
Visian CentraFLOW technology (V4c)
Thank You!
Eliminates the need for preoperative PIs!
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