Transcript tecnis - PromotoraAmericana

TECNIS® Multifocal IOL
MD to MD Speaker Presentation
2009.12.28-CT1551
Overview
• TECNIS® Multifocal IOL Introduction
• US Clinical Results
• The Principle of Optical Synergy
• Visual Acuity Comparisons
• Patient Selection and Implantation
2
The TECNIS® Multifocal IOL
The ONLY multifocal IOL that offers:
• Spherical aberration correction to essentially zero
• Better chromatic aberration reduction
• A pupil-independent, full-diffractive posterior surface
– High-quality vision in all light conditions
• Clear hydrophobic acrylic
– Not associated with glistenings
– Full transmission of healthy blue light
• Next-generation one-piece design
TECNIS® multifocal intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult
patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who
desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are
intended to be placed in the capsular bag.
3
The TECNIS® Multifocal IOL
US Clinical Results
• Nearly 90% of patients are able to function comfortably without
glasses at ALL distances
• Nearly 9 out of 10 patients NEVER wear glasses
• 91.7% patient satisfaction at 1 year
• 92.1% simultaneous 20/25 or better distance AND 20/32 or better
near
• At 1 year post-op, total occurrence of halos and glare showed
significant improvement.
4
TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.
TECNIS® Multifocal Acrylic IOL
13.0 mm
overall
diameter
TECNIS®
IOL
wavefrontdesigned
aspheric
surface
Frosted,
continuous
360° posterior
square edge
Posterior
diffractive
surface
6.0 mm
optic
diameter
5
Anterior side
Haptics
offset for 3
points of
fixation
Posterior side
TECNIS® Multifocal 1-Piece IOL Specifications
• Full diffractive posterior surface
– Pupil-independent
• Wavefront-designed aspheric anterior
surface
• Light distribution 50/50
• +5.0 D to +34.0 D in 0.5 D
increments
• Optical power add +4.0 D
– To optimize acuity at preferred
reading distance of 33 cm
• Model number: ZMB00
6
TECNIS® Multifocal Design Benefits
Ease of implantation
• The next-generation design
• Bag-friendly coplanar delivery
• Reduced center thickness for
a slim lens profile additionally
facilitates implantation
• Polished haptic loops reduce
friction and enable controlled,
gentle unfolding of the lens in
the capsular bag
7
TECNIS® Multifocal Design Benefits
ProTEC™ 360° Edge Design
• The 360° square edge is
designed to limit LEC
migration
• Uninterrupted contact with the
posterior capsular bag even at
the haptic-optic junction
• Unlike traditional single-piece
designs, it prevents cell
migration along the haptic
• The frosted-edge design
minimizes edge glare
8
TECNIS® Multifocal Design Benefits
Tri-Fix™ 3-Point Fixation
• Characterized by an offset haptic
design
• 3-point fixation provides:
– Constant capsular contact
– Additional stability over traditional single-piece
lenses
• Contact of sharp optic edge against the
posterior capsule limits LEC migration
• Rapid, long-term stabilization of the
optic and refraction
9
Posterior
Tri-Fix™
3-point
fixation
Anterior
US Clinical Results
US Clinical Results
Study Parameters
• Two multicenter, evaluator-masked comparative clinical evaluation
studies with a total of 306 bilateral TECNIS® Multifocal subjects
– 4-6 month study results presented for 297 bilateral multifocal and 119 bilateral
monofocal subjects
– One year study results presented for 292 bilateral multifocal
and 114 bilateral monofocal subjects
• Subject assignment was not randomized
– Based on patient’s choice for a multifocal or monofocal
11
TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.
US Clinical Results
Distance corrected binocular near visual acuity
at best distance (1-year)
100
94.1
81.7
80
% of
Patients
N=290
60
99.0
49.7
40
20
0
1.0 (20/20)
or better
12
0.8 (20/25)
or better
TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.
0.6 (20/32)
or better
0.5 (20/40)
or better
US Clinical Results
Spectacle Usage (1 year)
100.0
86.2
80.0
% of
Patients
N=290
60.0
40.0
20.0
12.8
1.0
0.0
Never
13
Sometimes
TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.
Always
US Clinical Results
Combined 20/25 or better distance and
20/32 or better near (1-year)
100.0
80.0
% of
Patients
92.1
81.4
60.0
40.0
N=291
20.0
0.0
Uncorrected
14
TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.
Distance Corrected
US Clinical Results
Ability to function comfortably
without glasses (1 year)
100
96.9
89.7
95.5
80
% of
Patients
60
40
N=290
20
0
Near
15
Intermediate
TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.
Distance
Important Safety Information
Important Safety Information – TECNIS ® Multifocal IOL
Caution: Federal law restricts this device to sale by or on the order of a physician. (Rx only can be used in place of
this text)
Indications: TECNIS® Multifocal intraocular lenses are indicated for primary implantation for the visual correction of
aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by
phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence.
The intraocular lenses are intended to be placed in the capsular bag.
Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use
labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Some visual effects associated with
multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a
perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients,
the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low
illumination conditions. On rare occasions these visual effects may be significant enough that the patient will request
removal of the multifocal IOL. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens
compared to a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night
or in poor visibility conditions. Patients with a predicted postoperative astigmatism >1.0D may not be suitable
candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential
spectacle independence.
16
Important Safety Information
Important Safety Information – TECNIS ® Multifocal IOL
Precautions: The central one millimeter area of the lens creates a far image focus, therefore patients with abnormally
small pupils (~1 mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however,
because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such
patients will derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal
patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal
stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront
measurements as two different wavefronts are produced (one will be in focus (either far or near) and the other
wavefront will be out of focus); therefore incorrect interpretation of the wavefront measurements is possible. The longterm effects of intraocular lens implantation have not been determined; therefore implant patients should be monitored
postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled
glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully
monitored postoperatively. Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt
solution or sterile normal saline. Do not store in direct sunlight or over 45C. Emmetropia should be targeted as this
lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve
centration.
Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the Tecnis®
Multifocal lens was macular edema, which occurred at a rate of 2.6%. Other reported reactions occurring in 0.3 – 1.2%
of patients were hypopyon, endophthalmitis, and secondary surgical intervention (including biometry error, retinal
repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and patient dissatisfaction).
Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.
17
Optical Synergy
Multiple Factors Affect Patient Outcomes
• Multiple lens design and material attributes affect quality of vision,
including:
– Spherical aberration correction
– Chromatic aberration correction
– Material clarity
– Light transmission
• For multifocal lenses, pupil-independence also needs to be
considered
• While each lens attribute provides an individual benefit, the total
benefit of these combined attributes can create a significant visual
improvement
19
Advantage:
Correcting Spherical Aberration to Zero
The Average Cornea Eye (ACE) Model
• The average cornea eye (ACE) model was developed by collecting
topography measurements from a significant sampling of cataract
patients*
• This study concluded that the average amount of corneal spherical
aberration is +0.27 microns throughout life
• Multiple studies with over 500 patients combined confirm this data
21
*Holladay JT, et al. J Refract Surg. 2002;18:683-91.
Studies Validating the ACE Model
Bellucci R, Scialdone A, Buratto L, et al. Visual acuity and contrast sensitivity comparison between Tecnis
and AcrySof SA60AT intraocular lenses: a multicenter randomized study. J Cataract Refract Surg.
2005;31(4):712-717.
Holladay JT, Piers PA, Koranyi G, van der Mooren M, Norrby NE. A new intraocular lens design to reduce
spherical aberration of pseudophakic eyes. J Refract Surg. 2002;18(6):683-91.
Kennis H, Huygens M, Callebaut F. Comparing the contrast sensitivity of a modified prolate anterior surface
IOL and of two spherical IOLs. Bull Soc Belge Ophtalmol. 2004;294:49-58.
Kershner RM. Retinal image contrast and functional visual performance with aspheric, silicone, and acrylic
intraocular lenses. Prospective evaluation. J Cataract Refract Surg. 2003;29(9):1684-1694.
Martinez Palmer A, Palacin Miranda B, Castilla Cespedes M, et al. [Spherical aberration influence in visual
function after cataract surgery: prospective randomized trial.] Arch Soc Esp Oftalmol. 2005;80(2):71-78.
Spanish language
Mester U, Dillinger P, Anterist N. Impact of a modified optic design on visual function: clinical comparative
study. J Cataract Refract Surg. 2003;29(4):652-660.
Packer M, Fine IH, Hoffman RS, Piers PA. Prospective randomized trial of an anterior surface modified
prolate intraocular lens. J Refract Surg. 2002;18(6):692-696.
Piers PA. Use of adaptive optics to determine the optimal ocular spherical aberration. J Cataract Refract
Surg. 2007; 33:1721–1726.
Wang L, Koch DD. Ocular higher-order aberrations in individuals screened for refractive surgery. J Cataract
Refract Surg. 2003; 29:1702-08. ?
22
Patented Wavefront-Designed Optic
The TECNIS® Multifocal aspheric surface was designed using the
ACE model
• Provides -0.27 microns of spherical aberration to correct residual
spherical aberration to essentially zero*
23
*Data on file. Abbott Medical Optics Inc.
Why Target Zero Spherical Aberration?
• At this time, the average
spherical aberration of
the eye is zero
• Spherical aberration increases
with age
0.50
Microns (Ocular spherical aberration Z(4,0))
• Peak visual performance
occurs around age 19-25
0.25
0.00
SA (<25 years)
mean 0.02
(SD 0.052)
-0.25
SA (>25 years)
mean 0.042
(SD 0.038)
-0.50
20
25
30
35
Age (year)
Spherical aberration of young subjects
(<25) with visual acuity better than 20/15
have zero spherical aberration on average
24
*Artal P, et al. Presented at ESCRS 2006.
Spherical Aberration Correction
Correcting spherical aberration (SA) to zero results in sharper
focus of light and therefore sharper vision at both near and
distance.
*
TECNIS® Multifocal IOL
25
*In the average cataract patient
*
ReSTOR® +3.0 IOL
Spherical Aberration Correction
There is a measurable difference
An IOL that fully corrects spherical aberration can provide a 13%
increase in contrast over an IOL that leaves +0.1 residual
spherical aberration*
MTF measurements based on ACE cornea model, which is derived from wavefront
measurements of actual cataract patients and validated by numerous studies.
26
*Zhao H, et al. Presented at ESCRS. 2009.. Theoretical analysis.
Advantage:
Correcting Chromatic Aberration
Chromatic Aberration Correction
What is chromatic aberration?
• Occurs when light is separated into its spectral components
• These wavelengths refract differently, creating multiple focal points
28
Chromatic Aberration Correction
Factors affecting chromatic aberration correction:
Optic Material
• The chromatic aberration of optical materials can be expressed by
their Abbe numbers
• The higher the number, the greater chromatic aberration reduction,
especially for distance vision
Optic Design
• A diffractive surface and a high add power correct for lens-induced
chromatic aberration at the near focus
29
Chromatic Aberration Correction
TECNIS® Multifocal IOL material provides better chromatic
aberration correction due to three factors:
1.
Diffractive surface corrects chromatic aberration at near focus for all pupil sizes
2.
+4.0 D add power corrects ocular chromatic aberration at near focus better than a +3.0 D
add power
3.
Material has a higher Abbe number and therefore less chromatic aberration at the distance
focus*
TECNIS® Multifocal IOL
30
*Zhao H. Mainster M. Br J Ophthalmol . 2007
ReSTOR® +3.0 IOL
Chromatic Aberration Correction
• AMO® hydrophobic acrylic has
the highest Abbe number of IOLs
tested*
• This can mean up to a
12% increase in contrast
compared to the AcrySof
material**
Comparison of Abbe Numbers*
60
55
47
50
43
40
37
30
20
10
0
31
*Zhao H. Mainster M. J Cataract Refract Surg. 2007
**Zhao H, et al. Presented at ESCRS. 2009.
AMO Acrylic
Crystalline Lens
Hoya Acrylic
Alcon Acrylic
Combining Spherical and Chromatic Aberration
Correction
Several studies have shown the correction of chromatic
aberration and spherical aberration together is more
beneficial than the sum of the two individual corrections.
32
Yoon GY, Williams DR. J Opt Soc Am A Opt Image Sci Vis. 2002;19:266-275.
Manzanera S, et al. Ophthalmol Vis Sci. 2007;48:E-Abstract 1513.
Zhao H, et al. Presented at ESCRS. 2009.
Advantage: Material Clarity
Lathing vs. Injection Molding
• TECNIS® Multifocal IOL is manufactured using a proprietary diamond
cryolathing process
• The advantage of cryolathing over injection
molded IOLs:
– Ensures refractive consistency of the material
– Limits microvoid formation from high temperature fluctuations, which have been
shown to cause glistenings*
34
*Miyata A, et al. J Cataract Refract Surg. 2004.
Incidence of Glistenings
Glistenings can cause
• A loss in contrast sensitivity
– Eyes without glistenings were found to
have a 40% increase in contrast
sensitivity at high spatial frequencies*
• Decreased visual acuity
– A study has shown that eyes with higher
grades of glistenings had a small but
significantly greater decrease in visual
acuity than those with lesser grades**
35
*Gunenc U, et al. J Cataract Refract Surg. 2001.
**Christiansen G, et al. J Cataract Refract Surg. 2001.
Glistenings
present in an
AcrySof®
ReSTOR® lens
Advantage: Blue Light Transmission
Transmission of Blue Light
• Blue light is proven to be
essential for optimal
scotopic vision*
• Blue light provides 35% of
scotopic sensitivity*
37
*Mainster MA. Br J Ophthalmol. 2006.
Why Scotopic Sensitivity is Important
• Scotopic visual sensitivity decreases twice as fast with aging than
photopic sensitivity*
– Scotopic sensitivity decreased at a rate of 0.08 log units per decade vs. 0.04 log
units for photopic sensitivity
• Scotopic vision declines with age, even in healthy eyes with no
cataract or retinal problems**
…so why reduce scotopic sensitivity further?
38
*Jackson GR, Owsley C. Vision Res. 2000.
**Mainster MA. Br J Ophthalmol. 2006.
Better Scotopic Vision with Blue Light
Transmission
AMO® hydrophobic acrylic lenses provide up to 21% more
scotopic sensitivity compared to blue-blocking IOLs*
Scotopic Sensitivity Reduction
0
0
-5
-10
-15
-14
-15
-20
-21
-25
AcrySof® Hoya 20D AcrySof® AMO® UVNatural 30D
IOL
Natural 20D blocking
IOL
39
*Mainster MA. Br J Ophthalmol. 2006.
Why Were Blue-Blocking IOLs Developed?
• Interest in blocking blue-light is motivated by the unproven hypothesis
that phototoxicity from environmental light exposure can cause AMD*
• 10 of 12 major epidemiological studies show no correlation between
AMD and lifelong light exposure
40
Mainster MA. Presented at ASCRS .2009.
The AREDs Study Results
• Study results show NO effect of cataract surgery on the risk of
advanced AMD progression
• The significance of this study and the difference in
these findings compared to earlier studies that reported an
association can be attributed to:
– Large number of participants with over 4,500 people
– Follow-up length of 10 years on average
– Inclusion of more people at a greater risk for AMD than population-based studies
41
Chew EY. Ophthalmology. 2009.
What We Didn’t Know
• The first blue-light blocking IOLs were designed prior to the discovery
of the role of blue light sensitive retinal ganglion photoreceptors and
their relation to melatonin suppression*
– The release and suppression of melatonin affects sleep patterns, mood, memory, and
systemic health
• Cataract surgery with a UV-blocking IOL that transmits blue light has
been shown to decrease insomnia and daytime sleepiness**
*Thapan K. J Physiol. 2001.
42
**Asplund. Arch Gerontol Geriatr. 2002 and 2004.
Advantage: Pupil Independence
With a Full Diffractive Surface
Full Diffractive Surface = Pupil Independence
MTF (50 c/mm)for
for near
MTF (50c/mm)
near
MTF (50 c/mm) for
for farfar
MTF (50c/mm)
0.40
0.35
0.35
0.30
0.25
TECNIS® ZMB00
0.20
ReSTOR® 3.0
0.15
0.10
MTF (50 c/mm)
MTF (50 c/mm)
0.30
0.25
0.20
TECNIS® ZMB00
ReSTOR® 3.0
0.15
0.10
0.05
0.05
0.00
0.00
3mm
5mm
Pupil Size (mm)
3mm
5mm
Pupil Size (mm)
MTF measurements based on ACE cornea model, which is derived from wavefront
measurements of actual cataract patients and validated by numerous studies.
44
Data on file. Abbott Medical Optics Inc.
Full Diffractive vs. Apodized Diffractive
Effect in Bright Light Conditions
• In photopic conditions, light is distributed equally to near and distance
focal points
• Light already begins to shift to distance at under 2mm pupil size with
the apodized design
TECNIS® Multifocal IOL
45
Alfonso JF, JCRS. 2009
ReSTOR® +3.0 IOL
Full Diffractive vs. Apodized Diffractive
Effect in Low Light Conditions
As the pupil widens in mesopic conditions:
• TECNIS® Multifocal IOL is pupil-independent so light is still distributed equally to near
and distance focal points, retaining high-quality near vision
• The apodized design functions as a monofocal lens on the outer perimeter, therefore
distributing more light to distance and degrading the quality of near vision
TECNIS® Multifocal IOL
46
ReSTOR® +3.0 IOL
Light Scatter
• Having a posterior diffractive surface reduces the amount of internal
reflections more than an anterior diffractive surface
• A lower refractive index reduces reflections
– TECNIS® Multifocal IOL: 1.46 RI
– ReSTOR® 3.0 IOL: 1.55 RI
47
Comparing Performance
Distance Performance
MTF (50 c/mm) for far
Distance
0.40
0.35
MTF (50 c/mm)
0.30
0.25
TECNIS® ZMB00
0.20
ReSTOR® 3.0
0.15
0.10
0.05
0.00
3mm
5mm
Pupil Size (mm)
MTF measurements based on ACE cornea model, which is derived from wavefront
measurements of actual cataract patients and validated by numerous studies. Testing
was performed with polychromatic light.
49
Data on file. Abbott Medical Optics Inc.
Near Performance
Near
MTF (50 c/mm) for near
0.35
MTF (50 c/mm)
0.30
0.25
0.20
TECNIS® ZMB00
ReSTOR® 3.0
0.15
0.10
0.05
0.00
3mm
5mm
Pupil Size (mm)
MTF measurements based on ACE cornea model, which is derived from wavefront
measurements of actual cataract patients and validated by numerous studies. Testing
was performed with polychromatic light.
50
Data on file. Abbott Medical Optics Inc.
Intermediate Vision
TECNIS® Multifocal IOL provides excellent intermediate vision
without sacrificing near vision due to:
• High-quality visual acuity at near and distance focal points
allow better depth of focus and therefore better vision in the
intermediate range
• A larger central zone is designed to enhance intermediate
• A 89.7% spectacle independence rate at intermediate confirms that
TECNIS® Multifocal IOL patients have excellent, full range vision*
51
*TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.
Patient Selection and Implantation
Patient Selection
• No contraindications
– e.g., recurrent severe inflammation or uveitis
• Bilateral implantation
• Postoperative astigmatism <0.75 D
• Postoperative emmetropia or max. <0.75 D hyperopia
• Patient motivation (e.g., high diopter glasses, hyperopia, spectacle
independence)
• Visual expectations of the patient
53
Exclusion Criteria
• Macular pathologies, glaucoma with severe visual
field loss
• Monofocal IOL already in one eye (relative exclusion)
• Expected astigmatism > 0.75 D
• Expected myopia > +/- 0.5 D (in post-op spherical equivalent)
• Unrealistic visual expectations
• Happy with reading glasses
• Surgical complications, such as capsulorhexis tear, capsular folds,
fixation in sulcus
• Patient is at risk for developing PCO
54
The One Series™ Ultra Implantation System
Advanced control and
ease-of-use
• Technologically advanced
insertion system specifically
designed for the nextgeneration 1-Piece IOL
• More controlled lens
delivery using a syringestyle inserter with Y-tip
plunger rod
• Easy-to-use, rear-loading
cartridge
• Controlled, gentle unfolding
of the lens in the eye
55
The One Series™ Ultra Implantation System
One Series™ Ultra
Cartridge
Micro Tip: coplanar
lens delivery
Canopy assists in folding of
leading haptic
Rear-loading cartridge
Inserter
Blue Y-tip plunger
rod assists lens
manipulation
postimplantation
Syringe style inserter
results in controlled,
predictable lens delivery
Snap in design locks in cartridge for
secure insertion
56
In Summary
TECNIS® Multifocal IOL provides sharper vision and higher patient
satisfaction by:
• Correction of spherical aberration to essentially zero
• Reduction of chromatic aberration
• Pupil independence with a full diffractive surface
• Transmission of blue light needed for scotopic vision
• Low incidence of glistenings
• High visual acuity and spectacle independence
at ALL distances
57
References
Alfonso JF, Fernández-Vega L, Amhaz H, Montés-Micó R, Valcárcel B, Ferrer-Blasco T. Visual function after
implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg. 2009 May;35(5):885-92
Artal P, Alcon E, Villegas E. Spherical aberration in young subjects with high visual acuity. Presented at ESCRS
2006, Paper 558.
Asplund R, Eidervik, Linblad B. The development of sleep in persons undergoing cataract surgery. Arch Gerontol
Geriatr. 2002 Sep-Oct;35(2):179-87.
Asplund R, Lindblad BE. Sleep and sleepiness 1 and 9 months after cataract surgery. Arch Gerontol Geriatr 2004;
38:69-75.
Chew EY, Sperduto RD, Milton RC, et al. Risk of advanced age-related macular degeneration after cataract surgery:
AREDS report 25. Ophthalmology2009;116:297-303.
Christiansen G, Durcan FJ, Olson RJ, Christiansen K. Glistenings in the AcrySof intraocular lens: Pilot study. J
Cataract Refract Surg. 2001;27:728-733.
Glasser A, Campbell MC. Presbyopia and the optical changes in the human crystalline lens with age. Vision Res.
1998;38(2):209-29.
Gunenc U, Oner FH, Tongal S, et al. Effects on visual function of glistenings and folding marks in AcrySof intraocular
lenses. J Cataract Refract Surg Oct 2001, 27(10) p1611-4.
Holladay JT, Piers PA, Koranyi G, van der Mooren M, Norrby NE. A new intraocular lens design to reduce spherical
aberration of pseudophakic eyes. J Refract Surg. 2002;18(6):683-91.
Jackson GR, Owsley C. Scotopic sensitivity during adulthood. Vision Res. 2000;40(18):2467-73.
Mainster MA, Violet and blue light blocking intraocular lenses: photoprotection vs. photoreception. Br J Ophthalmol
2006: 90; 784-792.
58
References
Manzanera S, Piers P, Weeber H, Artal P. Visual benefi t of the combined correction of spherical and chromatic
aberrations. Poster presented at: Annual Meeting of the Association for Research in Vision and Ophthalmology; 2007
May 7; Fort Lauderdale, Florida. Available at: http://lo.um.es/publications/arvoeabstracts.htm. Accessed May 21, 2008.
Miyata A, Yaguchi S. Equilibrium water content and glistenings in acrylic intraocular lenses. J Cataract Refract Surg.
2004;30:1768-1772.
Package Insert. TECNIS® Foldable Posterior Chamber Intraocular Lens. Abbott Medical Optics Inc.
TECNIS Foldable Posterior Chamber Intraocular Lens [package insert]. Santa Ana, Calif. Abbott Medical Optics Inc.
TECNIS Multifocal Foldable Acrylic Intraocular Lens [package insert]. Santa Ana, Calif: Abbott Medical Optics Inc.
Thapan K, Arendt J, Skene DJ. An action spectrum for melatonin suppression: evidence for a novel non-rod, non-cone
photoreceptor system in humans. J Physiol. 2001;535:261-7.
Tognetto D, Toto L, Sanguinetti G, Ravalico G. Glistenings in foldable intraocular lenses. J Cataract Refract Surg.
2002;28:1211-1216.
Yoon G, Williams DR. Visual performance after correcting the monochromatic and chromatic aberrations of the eye. J
Opt Soc Am A. 2002;19:266-275.
Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol.
2007;91(9):1225-1229.
Zhao H, Piers PA, Mainster MA. The additive effects of different optical design elements contributing to contrast loss in
pseudophakic eyes implanted with different aspheric IOLs. Presented at: 27th Congress of the ESCRS; 2009 Sep 4-8;
Barcelona, Spain.
59
Important Safety Information
Important Safety Information – TECNIS ® Multifocal IOL
Caution: Federal law restricts this device to sale by or on the order of a physician. (Rx only can be used in place of
this text)
Indications: TECNIS® Multifocal intraocular lenses are indicated for primary implantation for the visual correction of
aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by
phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence.
The intraocular lenses are intended to be placed in the capsular bag.
Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use
labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Some visual effects associated with
multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a
perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients,
the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low
illumination conditions. On rare occasions these visual effects may be significant enough that the patient will request
removal of the multifocal IOL. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens
compared to a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night
or in poor visibility conditions. Patients with a predicted postoperative astigmatism >1.0D may not be suitable
candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential
spectacle independence.
60
Important Safety Information
Important Safety Information – TECNIS ® Multifocal IOL
Precautions: The central one millimeter area of the lens creates a far image focus, therefore patients with abnormally
small pupils (~1 mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however,
because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such
patients will derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal
patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal
stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront
measurements as two different wavefronts are produced (one will be in focus (either far or near) and the other
wavefront will be out of focus); therefore incorrect interpretation of the wavefront measurements is possible. The longterm effects of intraocular lens implantation have not been determined; therefore implant patients should be monitored
postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled
glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully
monitored postoperatively. Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt
solution or sterile normal saline. Do not store in direct sunlight or over 45C. Emmetropia should be targeted as this
lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve
centration.
Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the Tecnis®
Multifocal lens was macular edema, which occurred at a rate of 2.6%. Other reported reactions occurring in 0.3 – 1.2%
of patients were hypopyon, endophthalmitis, and secondary surgical intervention (including biometry error, retinal
repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and patient dissatisfaction).
Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.
61
Important Safety Information
Important Safety Information – DK7786 Handpiece with the One Series Ultra Cartridge Implantation System
Caution: Federal law restricts this device to sale by or on the order of a physician.
Indications: The DK7786 handpiece with the One Series Ultra cartridge implantation system is used to fold and assist
in inserting TECNIS® 1-Piece intraocular lenses (IOL), ONLY into the capsular bag.
Warnings: The DK7786 handpiece with the One Series Ultra cartridge implantation system should only be used with
TECNIS® 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger
until the optic body has been completely released from the cartridge tube. The lens and cartridge should be discarded if
the lens has been folded within the cartridge for more than 5 minutes. If the IOL is not properly placed in the cartridge,
the IOL may be damaged and/or implanted upside down. Do not attempt to modify or alter this device or any of the
components, as this can significantly affect the function and/or structural integrity of the design. Use of methyl cellulose
viscoelastics is not recommended as they have not been validated with this implantation system. Do not implant lens if
rod tip becomes jammed in the cartridge.
Precautions: The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use
the AMO Healon® family of viscoelastics. Do not use balanced salt solution. The combination of low operating room
temperatures and high IOL diopter powers may require a slower delivery. Do not use if any component of this
implantation system has been dropped or inadvertently struck while outside of the shipping case. Do not store the
cartridges at temperatures under 5°C or over 30°C.
Contraindications: Do not use the handpiece if the rod tip appears nicked or damaged in any way.
AMO, TECNIS, ProTEC, Tri-Fix, and One Series are trademarks owned by or licensed to Abbott Laboratories, its
subsidiaries or affiliates. AcrySof and ReSTOR are trademarks of Alcon, Inc.
©2010 Abbott Medical Optics Inc.
62