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IOLs

Tecnis 1 Piece Iol

Tecnis 1 piece Iol

IT'S THE ONE WITH THE NEXT-GENERATION DESIGN

ProTEC™ 360° edge design increases protection

1 2
360° square edge for uninterrupted contact at the haptic-optic junction Frosted edge designed to minimize unwanted edge glare
AcrySof® IOL TECNIS® 1-Piece IOL
3 4
Limits LEC migration at the haptic-optic junction17

Tri-Fix™ 3-Point Fixation designed to increase stability

Tri-Fix™ Design

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  • Haptics offset allows three points of capsular bag fixation
  • Provides refractive predictability, long-term stability, and centration

TECNIS® 1-Piece IOL increases ease of implantation

  • Bag-friendly, coplanar delivery
  • Proprietary surface treatment for ease of unfolding
Haptic Loops Slim Lens Profile
6 7
Polished haptic loops enable controlled, gentle unfolding in capsular bag Reduced center thickness for slim lens profile facilitates implantation

Lens features

TECNISIOLs are the FIRST and ONLY wave-front designed IOLs with claims approved by the FDA for:

  • Reduced spherical aberration3
  • Improved functional vision3
  • Improved night driving simulator performance3

The TECNISIOL reduced spherical aberration to essentially zero3

A clinical study showed that the average ocular spherical aberration of TECNIS™ IOL eyes was not significantly different from zero.3

Total Ocular Spherical Aberration of TECNIS IOL Eyes is Not Significantly Different From Zero3

Mean Spherical Aberration Measurements, 90±15 Days Postoperatively, Study 001: Z9000: N=25; Lens with Spherical Optic: N=243

Improved Functional Vision

TECNIS™ IOLs are likely to provide a meaningful safety benefit to elderly drivers3,10

In a simulated night-driving study, at 55 mph the TECNIS™ Lens provided an additional 45 feet of identification distance, allows for a second of additional reaction time, when compared to a leading competitor.3
  • In the study, the TECNIS™ lens improved the identification distance for a pedestrian hazard by 45 feet compared to a traditional spherical lens implant3
  • At 55 mph, the 45-foot increase in visibility with the TECNIS™ lens allows for an additional half-second (0.50 second) to perceive and react to a driving hazard compared to a traditional spherical lens implant3,10
  • In comparison, the addition of the center high-mounted brake lights only improved driver reaction time by 0.35 seconds10
  1. Artal P, Alcón E, Villegas E. Spherical aberration in young subjects with high visual acuity. Presented at: XXIV Congress of the European Society of Cataract and Refractive Surgeons; September 9-13, 2006; London, England.
  2. Artal P, Berrio E, Guirao A, Piers P. Contribution of the cornea and internal surfaces to the change of ocular aberrations with age. J Opt Soc Am A Opt Image Sci Vis. 2002;19(1):137-143.
  3. Package insert. TECNIS™ Foldable Posterior Chamber Intraocular Lens. Advanced Medical Optics, Inc.
  4. Packer M, Fine IH, Hoffman RS. Functional vision, wavefront sensing, and cataract surgery. Int Ophthalmol Clin. 2003;43(2):79-91.
  5. Holladay JT, Piers PA, Koranyi G, et al. A new intraocular lens design to reduce spherical aberration of pseudophakic eyes. J Refract Surg. 2002;18:683-691.
  6. Guirao A, Tejedor J, Artal P. Corneal aberrations before and after small-incision cataract surgery. Invest Ophthalmol Vis Sci. 2004;45(12):4312-4319.
  7. 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.
  8. Wang L, Dai E, Koch DD, Nathoo A. Optical aberrations of the human anterior cornea. J Cataract Refract Surg. 2003;29(8):1514-1521.
  9. 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.
  10. McBride DK, Matson W. Assessing the significance of optically produced reduction in braking response time: possible impacts on automotive safety among the elderly. Potomac Institute for Policy Studies. April 1, 2003.
  11. Glasser A, Campbell MC. Presbyopia and the optical changes in the human crystalline lens with age. Vision Res. 1998;38:209-229.
  12. Smith G, Cox MJ, Calver R, et al. The spherical aberration of the crystalline lens of the human eye. Vision Res. 2001;41(2):235-243.
  13. Guirao A, Gonzalez C, Redondo M, et al. Average optical performance of the human eye as a function of age in a normal population. Invest Ophthalmol Vis Sci.1999;40(1):203-213.
  14. Wang L, Koch D. Ocular higher-order aberrations in individuals screened for refractive surgery. J Cataract Refract Surg. 2003;29(10);1896-1903.
  15. Holzer M, Auffarth G. Data presented at the DOC 2006.
  16. Oshika T, Klyce SD, Applegate RA, et al. Changes in corneal wavefront aberrations with aging. Invest Ophthalmol Vis Sci. 1999;40:1351-1355.
  17. Scilley K, Jackson GR, Owsley C, et al. Early age-related maculopathy and self-reported visual difficulty in daily life. Ophthalmol. 2002;109:1235-42.
  18. Data on file, Advanced Medical Optics, Inc.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. Buell W, Menapace R, Sacu S, et al. Effect of a silicone intraocular lens with a sharp posterior edge on posterior capsule opacification. J Cataract Refract Surg. 2004;30:1661-1667.

Compititive Advanced

Zero spherical aberration means peak visual performance1,11-15

Other IOLs (both spherical and aspheric) are designed to leave positive spherical aberration. The result is a diffusion of the light reaching the retina and a reduction in contrast sensitivity.

Residual Spherical Aberration (SA) of Monofocal Lenses (4 mm pupil)16
*Images simulated using ZernikeTool, created by George Dai, PhD.
†The point spread function (PSF) is the shape of a single, concentrated ray of light as it is projected through a lens. PSF is used to describe the distortion caused by aberrations present in an optical system.
††SA correction of lens at corneal plane.

TECNISIOL demonstrates increased contrast sensitivity in numerous clinical studies7,9,18-22

The clinical study conducted in 2002 and summarized in the labeling did not demonstrate a statistically significant improvement in contrast sensitivity. However, these more recent studies have shown statistically significant improvements in contrast sensitivity function with the TECNIS™ IOL.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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

A comprehensive review and analysis of the published and unpublished studies demonstrates that the TECNIS™ IOL provided a significant 38% (p<0.0001) overall improvement in contrast sensitivity results over a variety of control lenses with spherical optics.

The TECNISIOL shows significant improvement in Modulation Transfer Function (MTF) compared to other aspheric lenses

In one study, the TECNIS™ IOL shows over twice the improvement in MTF at 100 c/mm versus AcrySof™ IQ SN60WF and over three times the improvement in MTF at 100 c/mm versus LI61AO and Canon Staar KS-3Ai.18 In fact, LI61AO performs similarly to a spherical lens.

MTF Comparison of Lens Models (5 mm pupil)18

Modulation transfer function (MTF) measures the ability of an optical system to transfer contrast. The higher the MTF on the graph above, the higher percentage of contrast the lens is transferring for a given image.
(*Average Cornea Eye model)

  1. Artal P, Alcón E, Villegas E. Spherical aberration in young subjects with high visual acuity. Presented at: XXIV Congress of the European Society of Cataract and Refractive Surgeons; September 9-13, 2006; London, England.
  2. Artal P, Berrio E, Guirao A, Piers P. Contribution of the cornea and internal surfaces to the change of ocular aberrations with age. J Opt Soc Am A Opt Image Sci Vis. 2002;19(1):137-143.
  3. Package insert. TECNIS™ Foldable Posterior Chamber Intraocular Lens. Advanced Medical Optics, Inc.
  4. Packer M, Fine IH, Hoffman RS. Functional vision, wavefront sensing, and cataract surgery. Int Ophthalmol Clin. 2003;43(2):79-91.
  5. Holladay JT, Piers PA, Koranyi G, et al. A new intraocular lens design to reduce spherical aberration of pseudophakic eyes. J Refract Surg. 2002;18:683-691.
  6. Guirao A, Tejedor J, Artal P. Corneal aberrations before and after small-incision cataract surgery. Invest Ophthalmol Vis Sci. 2004;45(12):4312-4319.
  7. 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.
  8. Wang L, Dai E, Koch DD, Nathoo A. Optical aberrations of the human anterior cornea. J Cataract Refract Surg. 2003;29(8):1514-1521.
  9. 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.
  10. McBride DK, Matson W. Assessing the significance of optically produced reduction in braking response time: possible impacts on automotive safety among the elderly. Potomac Institute for Policy Studies. April 1, 2003.
  11. Glasser A, Campbell MC. Presbyopia and the optical changes in the human crystalline lens with age. Vision Res. 1998;38:209-229.
  12. Smith G, Cox MJ, Calver R, et al. The spherical aberration of the crystalline lens of the human eye. Vision Res. 2001;41(2):235-243.
  13. Guirao A, Gonzalez C, Redondo M, et al. Average optical performance of the human eye as a function of age in a normal population. Invest Ophthalmol Vis Sci.1999;40(1):203-213.
  14. Wang L, Koch D. Ocular higher-order aberrations in individuals screened for refractive surgery. J Cataract Refract Surg. 2003;29(10);1896-1903.
  15. Holzer M, Auffarth G. Data presented at the DOC 2006.
  16. Oshika T, Klyce SD, Applegate RA, et al. Changes in corneal wavefront aberrations with aging. Invest Ophthalmol Vis Sci. 1999;40:1351-1355.
  17. Scilley K, Jackson GR, Owsley C, et al. Early age-related maculopathy and self-reported visual difficulty in daily life. Ophthalmol. 2002;109:1235-42.
  18. Data on file, Advanced Medical Optics, Inc.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. Buell W, Menapace R, Sacu S, et al. Effect of a silicone intraocular lens with a sharp posterior edge on posterior capsule opacification. J Cataract Refract Surg. 2004;30:1661-1667.

Proven Hydrophobic Material

IT'S THE ONE WITH PROVEN HYDROPHOBIC ACRYLIC MATERIAL

There is no reason to block blue light

  • Blocking blue light does not provide any proven benefit, and increases the risk of compromising scotopic vision and normal circadian rhythms.(6)
  • Furthermore, multiple peer-reviewed studies have failed to find a link between age-related macular degeneration (AMD) and blue light exposure.(6)

Healthy blue light transmission is necessary for optimal scotopic vision(6)

Blue light provides 35%
of scotopic sensitivity
(6)
Blue-blocking IOLs reduce
scotopic sensitivity up to 21%
(6)

1

  • Scotopic vision declines with age, even in healthy eyes without cataract or retinal disease.(6)
  • Driving, mobility and peripheral vision problems have all been associated with reduced scotopic vision.(7)

Blue light is essential for healthy circadian rhythms(6)

Blue light is responsible for 55% of melatonin suppression(6)

3

  • Circadian rhythms are normal 24-hour cyclic activities in the body that influence sleep pattern, mood, alertness, and body temperature.(6)
  • Blue light helps regulate melatonin levels which influence circadian rhythms.(6)
  • Blue light has been shown to regulate melatonin and enhance alertness even in blind persons.(8)

BETTER MATERIAL REDUCES CHROMATIC ABERRATION

What is chromatic aberration?

Chromatic Aberration Present

Chromatic Aberration Corrected
4
  • Chromatic aberration is the uneven focusing of an optical system that causes different wavelengths of light to have different focal points.(9)
  • Chromatic aberration of optical materials can be expressed by their Abbe number. A higher Abbe number is associated with less chromatic aberration and better optical performance.(10,11)
  • Materials with low Abbe numbers and high chromatic aberration negatively impact contrast sensitivity.(10)
TECNIS® IOLs demonstrate lower chromatic aberration than AcrySof® IOLs

5

A higher Abbe number means less chromatic aberration and better photopic performance.(10)

At 30 cycles/degree (equivalent to 20/20), TECNIS® IOLs demonstrate 40% better contrast sensitivity than AcrySof® IOLs.(10)
n=refractive index

BETTER MATERIAL NOT ASSOCIATED WITH GLISTENINGS AND CALCIFICATION

  • Glistenings in IOLs may decrease visual acuity(12) and contrast sensitivity.(13)
  • Temperature fluctuations of other IOLs have been shown to cause glistening formation.(14)
  • TECNIS® IOLs are made with a proprietary cryo-lathing method that limits microvoid formation and high temperature fluctuations for reduced glistening formation.(14)
  • The TECNIS® 1-Piece hydrophobic acrylic material is not associated with calcification and opacification found in hydrophilic acrylic IOLs.(15)
Material issues associated with competitive IOLs

6

7
AcrySof® IOL implant after 1 year AcrySof® IOL implant after 2 years
8 9
Hydrophilic Acrylic Material TECNIS® 1-Piece Hydrophobic
Acrylic Material

The clinical study conducted in 2002 and summarized in the labeling did not demonstrate a statistically significant improvement in contrast sensitivity. However, these more recent studies have shown statistically significant improvements in contrast sensitivity function with the TECNIS® IOL.

A comprehensive review and analysis of the published and unpublished studies demonstrates that the TECNIS® IOL provided a significant 38% (p<0.0001) overall improvement in contrast sensitivity results over a variety of control lenses with spherical optics.

REFERENCES:

  1. Package Insert. TECNIS® Foldable Posterior Chamber Intraocular Lens. Advanced Medical Optics, Inc.
  2. Artal P, Alcon E, Villegas E. Spherical aberration in young subjects with high visual acuity. Presented at ESCRS 2006, Paper 558.
  3. Holzer MP. Data presented at the19th Congress of German Ophthalmic Surgeons (DOC), Nuremburg, Germany, 2006.
  4. Data on file. Advanced Medical Optics, Inc.
  5. Piers PA, Manzanera S, Prieto PM, et al. Use of adaptive optics to determine the optimal ocular spherical aberration. J Cataract Refract Surg. 2007;33:1721-1726.
  6. Mainster MA. Violet and blue light blocking intraocular lenses: Photoprotection vs. photoreception. Br J Ophthalmol. 2006;90:784-792.
  7. Owsley C, McGwin G, Scilley K, et al. Perceived barriers to care and attitudes about vision and eye care: Focus groups with older African Americans and eye care providers. Invest Ophth Vis Sci. 2006;47(4):2797-2802.
  8. Zaidl FH, Hull JT, Peirson SN, et al. Short-wavelength light sensitivity of circadian, papillary, and visual awareness in humans lacking an outer retina. Current Biology. 2007;17:2122-2128.
  9. Schwiegerling J. Theoretical limits to visual performance. Surv Ophthalmology. 2000;45(2):139-146.
  10. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol. 2007;91(9):1225-1229.
  11. Negishi K, Ohnumna K, Hirayama N, Noda T. Effect of chromatic aberration on contrast sensitivity in pseudophakic eyes. Arch Ophthalmol. 2001;119:1154-1158.
  12. Gunenc U, Oner FH, Tongal S, Ferliel M. Effects on visual function of glistenings and folding marks in AcrySof intraocular lenses. J Cataract Refract Surg. 2001;27:1611-1614.
  13. Christiansen G, Durcan FJ, Olson RJ, Christiansen K. Glistenings in the AcrySof intraocular lens: Pilot study. J Cataract Refract Surg. 2001;27:728-733.
  14. Miyata A, Yaguchi S. Equilibrium water content and glistenings in acrylic intraocular lenses. J Cataract Refract Surg. 2004;30:1768-1772.
  15. Tognetto D, Toto L, Sanguinetti G, Ravalico G. Glistenings in foldable intraocular lenses. J Cataract Refract Surg. 2002;28:1211-1216.
  16. Steinert RF. In vivo assessment of intraocular lens calcification in a rabbit model. Presented at ASCRS 2006.
  17. Nixon DR. New technologies for premium outcomes: Next generation phaco and TECNIS 1-Piece IOL. Presented at ESCRS, 2007.

Specifications




For more information, contact your AMO representative or call 1-877-AMO-4-LIFE

1. Value theoretically derived for a typical 20.0 D lens. AMO recommends that surgeons personalize their A-constant based on their surgical techniques and equipment, experience with the lens model, and post-operative results. 2. Calculated based on Holladay I formula (Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS. A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17-24).

Information for customers

For consumer information on TECNIS® IOLs please visit

http://www.tecnisiol.com