The Verisyse™ Phakic IOL

Surgeon Presentation
Outline
• Future of Myopic Refractive Surgery
• Phakic IOLs: Evolution & Technology
• The Verisyse™ Anterior Chamber, Iris-Fixated
Phakic IOL
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Product features
Clinical data
Patient selection, Pre-op Assessment
Implantation
Future of Myopic
Refractive Surgery
Myopic Refractive Surgery
• Total US Population = 286,158,000
– Myopic
• Mild (<-2.00 D)
• Moderate (-2.00 to -6.00 D)
• High (>-6.00 D)
72,000,000 25%
46,080,000
23,040,000
2,880,000
64%
32%
4%
• Surgeons are becoming progressively less willing
to attempt LASIK in high myopes (≥12 D)
(U.S. Bureau of Census, International Database/Archives of Ophthalmology,
March 1983 / Market Scope 2003 / WrongDiagnosis.com / Tay –
Study of 412,000 Singapore males.)
Refractive Surgery Trends
• New technologies will expand the total elective
refractive market – high myopia
– Phakic IOLs
– Pseudoaccommodative IOLs
• Refractive surgeries will grow to 2.5 to 3.0 million
procedure per year by 2010
• 58% of U.S. surgeons not currently performing
phakic IOL implantations plan to do so in
the future
(2003 Survey of ASCRS)
Verisyse™ Phakic IOL
• Larger 7 mm effective optical zone (vs. 5.0 mm
to 6.0 mm with LASIK)
• Diopter range (US): -5.00 to -20.0 D
• Additive technology – IOL can be removed
– Stable, removable split-haptic/iris fixation
• Endothelial cell loss within acceptable range
• Opens refractive market to vision correctionminded cataract surgeons
Verisyse™ Phakic IOL
• Challenges
– Requires large incision and suturing
– Enclavation process can be technically
challenging, learning curve
– Risk of infection (lower with fourth-generation
fluoroquinolones)
Verisyse™ Phakic IOL
• Benefit
– Tradeoff for greater surgical challenge is fewer
functional visual complications and high-quality,
high-contrast vision for patients who are not good
Custom LASIK candidates
Phakic Lenses
Evolution &
Technology
Early Anterior Chamber Lenses
1950’s
Strampelli
1953
Dannaheim
1954
Cogan Boberg-Ans
1954
• Significant Complications
– Poor fit / heavy
– Poor lens quality
– Poor surgical technique
• Angle-fixated lenses associated with ↑
complications
Barraquer
1954
The Verisyse™ Phakic IOL
• Verisyse® (Artisan™ in Europe)
– Design introduced in 1991
after 5 year trial
– Concave- Convex
configuration (low profile)
• Decreased risk of
endothelial damage
• Twice the effective
power range
The Verisyse™ Phakic IOL
(-5 TO -20 D) for the
Correction of Myopia:
Product Features
Verisyse™ Features
• Perspex CQ-UV PMMA
• 8.5 mm overall length
Myopic Lenses
VRSM5US050
5 mm Optic
VRSM6US060
6 mm Optic
-3.00 to -23.5 D in 0.50 D steps (in Europe)
Verisyse™ Features
• Enclavation site – attaches to
peripheral iris leaving anterior
chamber angles unobstructed
– Maintains 1.5 to 2.0 mm
distance from corneal
endothelium at the angle
– Allows wide dilation
1.5 to 2.0 mm
0.95 mm
Verisyse™ Features
• Split haptic fixation
– Attaches to peripheral iris
without inhibiting iris function
– Less risk of pupil ovalization
than with angle-fixated AC
phakic IOLs
– Avoids issues of PC phakic
IOLs (e.g. cataract formation)
Verisyse™ Features
• Lens is vaulted anteriorly to ensure clearance
from anterior lens capsule
– Vault range 0.35 to 0.93 mm, dependent on lens power
– Occupies ~ 30% of anterior chamber
– Lens / endothelium separation 2.03 to 3.25 mm
0.92 mm
0.92 mm
Verisyse™ Features
• Holds 60% of European market share for
phakic IOLs
– #1 design worldwide
• Resolves high degrees of ametropia while
retaining full range of natural accommodation
• Design has been in use for >18 years
• More than 150,000 phakic procedures have
been performed worldwide using the
Verisyse™ lens design
Clinical Data:
The FDA Study
Verisyse™ vs LASIK
FDA Study: Investigational Sites
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Assil – Sinskey Eye Institute
Arrowsmith Eye Institute
Eye Surgery Center of LA
Koch Eye Associates
Price Vision Group
Hunkeler Eye Center
Anis Eye institute
LSU Eye Center
Stanford University
Rothchild Eye Institute
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Emory University
UCLA/Maloney Vision Institute
John-Kenyon Eye Center
Minnesota Eye Consultants
Kremer Laser Eye Center
Ophthalmology Ltd
Manhattan Eye Ear & Throat
Bascom Palmer Eye Institute
Mackool Eye Institute
Moran Eye Center, U of Utah
Shiley Eye Institute, UCSD
FDA Study
• Prospective, nonrandomized study of 662
subjects (mean age 39.6 years)
– 493 of which were followed for one year and 231
followed for three years
• Correction of axial myopia with lens powers
from -5.00 D to -20 D
• Mean lens power (n=662): -12.6 D
BSCVA 20/40 or Better
First Eyes (n=662)
Percentage of Eyes
20/40 or Better
100
98.5
99.2
100
99.6
99.6
100
100
100
80
60
40
20
0
s
ar
Ye
3
s
ar
Ye
2
ar
s
Ye
th
1
on
M
11
s
7th
on
M
6
s
4th
on
M
2
1ks
ee
W
3
2p
eo
Pr
Best Spectacle Corrected Visual Acuity
100
Percentage of Eyes
100
99
80
81
94
94
79
99
99
99
94
100
100
83
90
79
60
60
40
20
0
preop
1 year
2 years
3 years
n=662
n=491
n=355
n=228
Time After Surgery
20/20 or better
20/25 or better
20/30 or better
20/40 or better
Change in BSCVA at Three Years
Percentage
of Eyes
6%
49%
Snellen Lines
Gained/Lost
0.3 %
-2
5.9%
-1
44.7%
0
38.8%
+1
8.4%
+2
1.9%
>+2
Induced Astigmatism
• Incision size: 5.2 to 6.2 mm
• Some cylinder reduction by selective
incision placement
• Refractive cylinder change >2.0 D
– 2.4% of first eyes at one year (n=492)
– 2.0% of first eyes at two years (n=355)
– 3.5% of first eyes at three years (n=226)
• FDA safety target: <5%
Uncorrected Visual Acuity
Percentage of Eyes
First Eyes at Three Years
100
90
80
70
60
50
40
30
20
10
0
92
82
68
50
84
All first eyes
(n=231)
71
52
First eyes
targeted for
emmetropoia
and pre-op
BCVA 20/20 or
better (n=88)
31
20/20 or
better
20/25 or
better
20/30 or
better
20/40 or
better
Uncorrected Visual Acuity
Achieved Correction (D)
Predictability
Intended vs. Achieved Manifest Spherical Equivalent
6 Months
24.0
23.0
22.0
21.0
20.0
19.0
18.0
17.0
16.0
15.0
14.0
13.0
12.0
11.0
10.0
9.0
8.0
7,0
6.0
5.0
4.0
3.0
2.0
1.0
86% + 1.0 D
61% + 0.5 D
(with no enhancements)
3
4
5
6
7
8
9
10 11
12 13 14 15 16 17 18
Intended Correction (D)
19 20 21 22 23 24
Stability
2.00
0.00
-2.00
-4.00
-6.00
- 0.062 D
from 2 yr.
to 3 yr.
-0.019 D
from 6 mos.
to 1 yr.
-8.00
-10.00
-12.00
-14.00
Time After Surgery
yr
3
yr
2
yr
1
m
o
6
m
o
3
m
o
1
k
d
1
w
1
Pr
eo
p
-16.00
Visual Symptoms at Night
Subjects With At Least 1 Year Follow-up (n=412)
Subject Response
Subjects with Change in
Symptom:
p-value
Pre-op=No
Post-op=Yes
Pre-op=Yes
Post-op=No
Glare (26.4%; 98/371)
51%
49%
0.840
Halo (28.0%; 104/372)
65%
35%
0.002
Starburst (21.5%; 80/372)
55%
45%
0.371
*McNemar Chi-square test
Majority of subjects had no change
Contrast Sensitivity
Mesopic With Glare
Contrast Sensitivity
n=31*
300
100
30
Preop
Postop
10
3.0
p= 0.03
1.5
3
6
12
Cycles per Degree
*One eye analysis
18
Patient Satisfaction
Percentage of Subjects
Subjects With At Least 1 Year Follow-up (n=412)
100
90
80
70
Quality of
Vision
60
Satisfaction
with Surgery
50
40
Recommend
Procedure
30
20
10
0
Favorable
Neutral
Unfavorable
Conclusions
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Excellent uncorrected visual acuity
Excellent predictability
Good stability
Contrast sensitivity unchanged or improved
High subjective satisfaction rates
Verisyse™ Phakic IOL Implantation Versus
LASIK
Investigators conducted a prospective, randomized
comparison of Verisyse™ Phakic IOL implantation
with Excimer LASIK in myopic patients correcting
between -9.00 and -19.50 diopters.
(El Danasoury MA, et al. Ophthalmology. 2002;109:955-964)
• n=61 patients (90 eyes)
• mean SE refraction ~ –13.5 D
• 29.5% of patients received a Verisyse™ lens in
one eye and LASIK in the other eye
The Verisyse™ Phakic IOL is sold under the Artisan® name outside the US.
One-Year Outcomes
Verisyse™
(n=43 eyes)
LASIK
(n=41 eyes)
-0.64 ± 0.8 D
-0.87 ± 0.8 D
UCVA 20/20 or better, %
20.9
12.2
UCVA 20/40 or better, %
88.4
58.5
2 or more Snellen lines lost on BSCVA, %
0.0
14.6
2 or more Snellen lines gained on BSCVA (n)%
16.3
2.4
Contrast sensitivity ↓2 or more lines (n)%
4.7
14.6
Mean SE Refraction
The Verisyse™ Phakic IOL is sold under the Artisan® name outside the US.
Author Conclusions
• The Verisyse™ Phakic IOL and LASIK were
found to be similarly effective, stable and
reasonably safe for the correction of moderate
to severe myopia.
• The lens offered significantly better UCVA and
BSCVA, better contrast sensitivity, and a lower
enhancement rate.
Author Conclusions
• Patient preference was significantly in favor of
the Verisyse™ Phakic IOL, mainly because of
the higher quality vision; 72.2% of patients who
received both surgeries preferred the
Verisyse™ Phakic IOL.
Patient Selection &
Preoperative
Assessment
FDA Indication
• The reduction or elimination of myopia in
adults with myopia ranging from -5 D to
-20 D with less than 2.5 D of astigmatism
at the spectacle plane
• Patients with documented stability of
manifest refraction for the prior 6 months,
as demonstrated by a spherical equivalent
change of less than 0.50 D
The ‘Right’ Patient
• Dissatisfied with quality of vision or tired
of depending on glasses
• Unable to wear contact lenses
• Outside the optimal range of laser
refractive surgery
• Considers risks of natural lens exchange
not acceptable
• Likes the idea of a reversible procedure that
offers high-quality, high-contrast vision
The ‘Wrong’ Patient
• Age <21 years or with unstable refraction
• Anterior chamber depth <3.2 mm
• Less than the age-adjusted recommended
endothelial cell density
• Abnormal iris, such as peaked pupil or
elevated iris margin
• IOP >21 mm Hg
• Pupil width under mesopic conditions >5 mm
(5.0 mm optic)
• Inappropriate expectations
Patient Assessment
• Standard intraocular surgical workup
and measurement
– Lens selection dependent
• Precise Refraction
• Precise manual keratometry
• Accurate Biometry – Anterior Chamber Depth
(IOL Master™)
– Endothelial Cell Count
• Target refraction is emmetropia
VERICALC™ 1.1 Program
Note: Refraction is automatically corrected for vertex distance &
ACD is automatically corrected for lens vault value
Verisyse™
Implantation and
Post-surgical Protocol
Pre-Op Patient Prep
• Informed consent
– Elective surgery!
• Pre-Op Meds
– DO NOT DILATE
– Antibiotic/Non-steroidal anti-inflammatory
– Pilocarpine 1%
• Anesthesia
– Peri or Retrobulbar for initial eyes
– Local when experienced
Intraoperative Considerations
• Standard implant instrument set +
enclavation needle
• Scleral or limbal incision recommended
– Avoids post-op wound leaks
• Cohesive viscoelastic
– Easy removal - avoid post-op pressure spikes
– Avoid highly viscous brands (i.e. Healon® 5)
• < 1.4% sodium hyaluronate
– Recommended Healon®, Healon GV®
• Incision placement for astigmatism
correction when possible
– Clear corneal incision with sutures
Iridectomy / Iridotomy
• Iridectomy/iridotomy is essential
• YAG iridectomy can be performed
prior to surgery
Peripheral Iridectomy
Laser Iridectomy
Define Landmarks
• Anatomical
landmarks at
enclavation sites
– Alternatively,
mark longitudinal
axis of lens on
conjunctiva
6 mm
Enclavation
Sites
9:00
3:00
5 mm
12:00
Paracentesis
6:00
4:00
• Two (2) incisions at
10:00 & 2:00
8:00
– 0.50 mm
•
Angle incisions
toward enclavation
sites
Enclavation
Sites
10:00
2:00
12:00
Inject Viscoelastic
• Use cohesive viscoelastic (Healon®, Healon
GV®, etc.)
• Always fill from periphery both paracentesis
• Do not overfill
Incisions
• 5 to 6 mm incision
• Consider astigmatism
Stepped
Limbal
Clear Corneal
Insert Lens
• Ensure sufficient miosis
• Use implant forceps
• Visualize Iris/Pupil
Rotate Implant
• Inject viscoelastic over lens
• Rotate haptic to 3:00 & 9:00
• Center optic on pupil
Verisyse™ Instruments
Implant Forceps
Lens Manipulator, Straight
Enclavation Needle
Enclavation Pearls
1st Haptic
• Maintain chamber – Viscoelastic PRN
• Start with your non-dominant hand & enclavate
the corresponding haptic first
– If ambidextrous, temporal haptic first
• Insert enclavation needle in paracentesis first
Position Lens
Align vertical & longitudinal lens axis with reference marks
The Enclavation Process
Lens forceps stabilizes & positions lens
Enclavation needle pulls iris tissues into haptics
The Enclavation Process
• After aligning lens, peripheral iris tissue
is drawn into the split lens haptics
– Stable anchor – minimal tissue trauma
– Reversible
The Enclavation Process
Create small fold of iris
tissue & pull into haptic
Move needle down & create a larger fold of iris tissue
Pull fold of iris & needle through haptic aperture
Enclavation Tissue
Enclavate tissues from directly below split haptics
Enclavation
• Draw small amounts of
superficial iris tissue into
haptic in a circular fashion
• Repeat process until lens is
securely anchored to the iris
Watch Alignment
During Enclavation
• Lens moving
inferiorly
– Enclavate tissue
directly below
superior split haptic to
pull lens superiorly
Watch Alignment
During Enclavation
• Lens moving
superiorly
– Enclavate tissue
directly below inferior
split haptic to pull lens
inferiorly
Lens Fixation: Posterior View
Post-mortem specimen from 86 year-old with
Verisyse™ aphakic IOL in place for 6 years
Position Lens
1st Haptic
• Position haptic over enclavation site & identify
anatomical landmarks or reference marks
Enclavation
1st Haptic
How Much is Enough?
• If you think you have too much iris, you
probably don’t!
• Take multiple small bites in a clockwise,
circular fashion
Too Little
Too Much
Check Alignment
• If significant misalignment
– Reduce enclavation
• Place enclavation needle on top of enclavated
iris & push through split haptic
• Realign & re-enclavate
Position Lens
2nd Haptic
•
•
•
•
Maintain chamber – Viscoelastic PRN
Insert needle through paracentesis
Center optic on pupil (vertically)
Define landmarks under haptic
– Feed slightly peripheral
iris to avoid oval pupil
Enclavation
2nd Haptic
Inspect Lens
•
•
•
•
Reform chamber
Verify centration & pupil
Verify adequate enclavation
Re-position or re-enclavate if necessary
Remove Viscoelastic
• Place sutures & tie
– Leave one suture untied to
facilitate viscoelastic removal
• Carefully remove ALL
viscoelastic
• Tie remaining suture,
reform chamber, check for
leaks
Verisyse Implantation
Intraoperative Astigmatism
• 1 to 2 diopters
– Corneal & limbal incisions
• Incision placement & sutures
– Scleral incision
• LRI or corneal incisions (CI)
• 2 or more diopter
– Corneal & limbal
• Wait for cornea to stabilize – LRI, CI, laser
• LRI or corneal incisions
Post-Operative Astigmatism
• Evaluate patient satisfaction & functionality
– Correct astigmatism if patient is complaining or if
vision is not functional (drivers license, etc.)
• Wait for the cornea to stabilize
– LRI, CI,
– Laser corneal surgery
Post-Surgical Protocol
• Standard post-intraocular surgery meds
– Antibiotic, steroid, NSAID
• Eye shield for 1 week
• Return 1 day post-op to check:
– IOP
– Lens position & pupil
– Visual acuity
• Routine F/U and visual rehabilitation
Fair Balance
Intended Use Statement: Verisyse™ Phakic Intraocular Lenses are intended
for the reduction or elimination of myopia in adults with myopia ranging from
-5 to -20 diopters with less than or equal to 2.5 diopters of astigmatism at the
spectacle plane and whose eyes have an anterior chamber depth greater
than or equal to 3.2 mm, and for patients with documented stability of
manifest refraction for the prior six months as demonstrated by a spherical
equivalent change of less than or equal to 0.50 diopter. Rx Only.
Precautions: Do not resterilize this lens by any method; do not store the lens
at temperatures over 45°C (113°F). Warnings: Surgeons should consider the
risk/benefit ratio for adults with preoperative ocular pathology, including but
not limited to inflammation, distorted eye and microbial infection. Adverse
Events: Adverse events that have been documented as having occurred
following lens implantation include, but are not limited to, hyphema, retinal
detachment and lens dislocation. For a complete listing of precautions,
warnings and adverse events, refer to the package insert.