IT'S THE ONE TO CORRECT SPHERICAL ABERRATION TO ZERO

The FIRST and ONLY wavefront-designed IOL with claims approved by the FDA for:

• Reduced spherical aberration(1)
• Improved functional vision(1)
• Improved night driving simulator performance(1)
  – Meaningful safety benefit for drivers and pedestrians
  – Improved functional vision for other life situations under low-light conditions

Total Ocular Spherical Aberration of TECNIS® IOL Eyes is Not Significantly Different From Zero(1)*

Mean Spherical Aberration Measurements, 90±15 Days Postoperatively. Lens A9000: N = 25. Lens with spherical optic: N = 24.(1)

*The data as it appears here follows the OSA standard and has been changed from the original data to reflect a difference in sign (+or-) that exists between the WASCA measurement and the OSA standard.

• Multiple studies confirm that peak visual performance occurs at age 19, when spherical aberration is zero.(2,3)
• The human cornea has on average +0.27 microns of spherical aberration throughout life, but spherical aberration of the lens increases with age.(4)
• Clinical data shows that correcting residual spherical aberration to zero results in better visual outcomes and the best depth of focus.(5)

Zero spherical aberration = Peak visual performance

Residual Spherical Aberration of Monofocal Lenses (4 mm pupil)(4)

Image simulated using ZernikeTool, created by George Dai, PhD.

IT'S THE ONE FOR IMPROVED FUNCTIONAL VISION

Improved night-driving simulator performance(1)

TECNIS® IOLs are likely to provide a meaningful safety benefit to elderly drivers(1)

Identification distance at 55 mph(1)

In a simulated night-driving study, the TECNIS® IOL provided an additional 45 feet of identification distance and a ½ second of reaction time over a spherical IOL.(1)

Improvement in MTF over other aspheric lenses(4)

MTF Comparison (5 mm pupil)†

In a comparison of lens models at 100 c/mm, the TECNIS® IOL showed improvement in modulation transfer function (MTF) over twice that of the AcrySof® IQ (SN60WF) and over three times that of the SofPort® AO (LI61AO). †Average cornea eye model.(4)

High-quality vision in low-light conditions(4)

TECNIS® IOL	IOL with Residual Spherical Aberration
In aviation-type visual performance testing, vision in low-light (5 mm pupil) conditions was superior with the complete spherical aberration correction provided by the TECNIS® IOL. Actual images as seen in an eye model through the TECNIS® IOL and an IOL with residual spherical aberration.(4)

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.(4,6-11)

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.(4)

Indications and Important Safety Information

TECNIS® IOLs

Caution

Federal law restricts this device to sale by or on the order of a physician.

Indications

Tecnis® lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices 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.

Precautions

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.

Adverse Events

Adverse events occurred at rates between 1.6% and 3.3% during the clinical trials for Tecnis® IOLs or their “parent” IOLs. These events included macular edema, endophthalmitis, anterior lens tissue ongrowth, lens dislocation, hypopyon, corneal edema, iritis, hyphema, secondary glaucoma, and secondary surgical intervention. 

Attention

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

References

1. Package Insert. TECNIS® Foldable Posterior Chamber Intraocular Lens. Abbott 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. Abbott 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. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.

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