iDESIGN Patient Education Presentation (1)
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The document describes the iDESIGN Advanced WaveScan Studio System, a new technology for wavefront-guided LASIK. It captures over 1,200 data points from each eye, more than previous technologies, to create a highly personalized treatment plan. The system is indicated for correcting nearsightedness up to -11 diopters and astigmatism up to -5 diopters. Clinical studies showed 99% of patients had clear, sharp vision after surgery with few side effects. The system provides smarter technology for refractive eye surgery.
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iDESIGN Patient Education Presentation (1)
- 1. IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM Introducing
- 2. REFRACTIVE ERRORS Common eye conditions that prevent people from seeing well • Myopia (Nearsightedness) • Hyperopia (Farsightedness) • Astigmatism • Mixed Astigmatism Most vision problems occur because of some inability to focus the image on the retina February 5, 2016 2
- 3. WAVEFRONT-GUIDED LASIK • Highly precise map of the eye is generated, detailing all higher and lower refractive errors • This accurate assessment allows the surgeon to tailor the treatment that’s 100% personalized February 5, 2016 3
- 4. Technology Overview YOUR LASIK PROCEDURE JUST GOT SMARTER February 5, 2016 4
- 5. IDESIGN SYSTEM INDICATIONS The STAR S4 IR® Excimer Laser System and iDESIGN System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: • with myopia as measured by the iDESIGN System up to -11 D spherical equivalent with up to -5 D cylinder • with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN System refraction of: ─ Spherical Equivalent: Magnitude of the difference is less than 0.625 D ─ Cylinder: Magnitude of the difference is less than or equal to 0.5 D • 18 years of age or older • with refractive stability (a change of ≤1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery) February 5, 2016 5
- 6. February 5, 2016 6 YOUR LASIK PROCEDURE JUST GOT SMARTER • The only vision correction procedure that uses a unique process to map the eye’s entire visual pathway making it 100% personalized • With over 15 million procedures, iLASIK technologies have given people better vision , hassle free from glasses or contact lenses* *You may need reading glasses after laser surgery even if you did not wear them before.
- 7. February 5, 2016 7 • Captures more data about the imperfections of the eye than ever before* – Over 1,200 data points from each eye – More data for outstanding treatment accuracy • Uses a high-definition sensor that has 5x the resolution of previous technology* • 100% personalized treatment plan is based on this large amount of high-quality information As compared to the WaveScan System THE IDESIGN SYSTEM – SMART TECHNOLOGY
- 8. THE IDESIGN SYSTEM WAVEFRONT-GUIDED LASIK • Corrects a broader range of astigmatism (up to -5 D) in people with nearsightedness • Potential to capture complex, challenging eyes • 18 years of age or older February 5, 2016 8
- 9. THE IDESIGN SYSTEM RESULTS IN CLEARER, SHARPER VISION YOUR PATIENTS WILL ENJOY • 99% of people were not limited in active sports or outdoor activities after surgery1 • 99% of people had little to no difficulty with the clarity of their vision after surgery1 • 97% of people were satisfied with their vision after surgery1 • 93% of people had little to no difficulty driving at night after surgery1 • Majority of people achieved 20/16 or better vision after surgery1 February 5, 2016 91. Clinical Studies submitted to FDA: P930016/S044
- 10. iDESIGN System Overview YOUR LASIK PROCEDURE JUST GOT SMARTER February 5, 2016 10
- 11. REFRACTIVE MEASUREMENT February 5, 2016 11 Phoropter (Manifest) Method of Refraction One single data point WaveFront Method of Refraction Over 1,200 data points
- 12. HOW THE IDESIGN SYSTEM WORKS • It shines a light into the eye of the patient • The light travels as a bundle of rays which pass through the cornea, lens, vitreous and to the retina • The light rays then travel back out of the eye, through a set of tiny lenses, called a Hartmann-Shack lens array, and into a camera February 5, 2016 12
- 13. 5 MEASUREMENTS WITHIN A SINGLE CAPTURE SEQUENCE • Wavefront refraction • Wavefront aberrometry • Corneal topography • Keratometry • Pupillometry February 5, 2016 13
- 14. THE IDESIGN SYSTEM… Next-generation technology – working as a smarter brain – collecting more data about the imperfections of the eye than ever before Corrects nearsightedness up to -11 D, with up to -5 D of astigmatism Clearer, sharper vision for an improved visual well-being after surgery Backed by most trusted name in laser vision correction February 5, 2016 14
- 15. WHAT YOU NEED TO KNOW ABOUT THE IDESIGN SYSTEM DRIVEN WFG LASIK • Smart technology - captures more data than ever before • Gives you the freedom to possibly live hassle-free from contacts or glasses • Corrects a broader range of astigmatism (up to -5D) in people with nearsightedness. • Results in clearer, sharper vision you will enjoy day and night February 5, 2016 15
- 16. HEALTHCARE PROFESSIONAL INDICATIONS AND IMPORTANT SAFETY INFORMATION CAUTION: U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner. ATTENTION: Reference the Operator’s Manual for a complete listing of Indications and Important Safety Information. INDICATIONS: The STAR S4 IR Excimer Laser and iDESIGN Advanced WaveScan Studio (iDESIGN) System is indicated for wavefront-guided LASIK in patients with myopia as measured by iDESIGN System up to -11.00 D SE, with up to -5.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN System refraction of 1) SE: magnitude of the difference is ˂ 0.625 D, and 2) cylinder: magnitude of the difference is ≤ 0.5 D; with patients 18 years of age and older, and with refractive stability (a change of <1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). CONTRAINDICATIONS: Laser refractive surgery is contraindicated in patients with: collagen vascular, autoimmune, or immunodeficiency diseases, pregnant or nursing women, keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea, symptoms of significant dry eyes, corneal thickness would cause anticipated treatment to violate the posterior 250 microns (μm) of corneal stroma, advanced glaucoma, and uncontrolled diabetes. If the patients have severely dry eyes, LASIK may increase the dryness, this may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery, it may result in poor vision after LASIK. WARNINGS AND PRECAUTIONS: LASIK is not recommended in patients who: have a history of Herpes simplex or Herpes zoster keratitis, have severe allergies or tendency rub their eyes often, are taking the medication Isotretinoin (Accutane®), are taking antimetabolites for any medical conditions. The safety and effectiveness of this laser for LASIK correction have NOT been established in patients: with progressive refractive errors; previous corneal or intraocular surgery; or trauma in the ablation zone, who are taking the medication Sumatriptan (Imitrex®), or Amiodarone hydrochloride (Cordarone®), with corneal neovascularization within 1.0 mm of the ablation zone, over the long term (more than 1 year after surgery), for patients who engage in activities that could endanger or damage the LASIK flap, for patients who have a family history of degenerative corneal disease, history of inflammation of the eye, for patients who have a history of crossed eyes (strabismus) or who have undergone strabismus surgery, prior LASIK or Refractive Surgery, with history of any eye diseases or abnormalities such as corneal scars or active disease, and whose BSCVA is worse than 20/20. To reduce the risk of corneal ectasia, the posterior 250 microns (μm) of corneal stroma should not be violated. The treatment of highly myopic eyes necessitates the removal of significant amounts of corneal tissue. The iDESIGN System calculates the estimated residual bed depth using the pachymetry and intended flap thickness entered by the user. Actual flap thicknesses may vary. If the estimated residual stromal bed is ≤ 320 microns, an in-the-bed pachymetric measurement should be performed. ADVERSE EVENTS: Possible adverse events include loss of best spectacle corrected visual acuity (BSCVA), serious Transient Light Sensitivity Syndrome, serious primary open angle glaucoma, miscreated flap, melting of the flap, severe glare, and severe dry eyes. Complications can include corneal edema, epithelial ingrowth, diffuse lamellar keratitis, foreign body sensation, and pain. ©2015 Abbott Medical Optics Inc. Advanced CustomVue, WaveScan, iDESIGN, iDESIGN Advanced WaveScan Studio, STAR S4 IR, and iLASIK are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries, or affiliates. PP2015OTH0294 February 5, 2016 16 iDESIGN Advanced WaveScan Studio System with STAR S4 IR Excimer Laser
Editor's Notes
- The measurement and treatment of refractive errors has been profoundly beneficial to people. Over the last several hundred years, correcting errors of refraction with spectacles, and later contact lenses, has provided countless millions of people with good vision. With the advent of wavefront technology, we can now better assess the visual function of the eye. No longer restricted to measuring sphere and cylinder, wavefront aberrometers can now quantify other types of aberrations that can impair vision, such as coma and spherical aberration. Using these devices, we are gaining a much better appreciation of the optical characteristics of the eye. In addition to this robust diagnostic capability, wavefront technology is now being used to treat ocular aberrations in the form of wavefront-guided laser-assisted in situ keratomileusis (LASIK).
- WFG LASIK, is a variation of refractive surgery where, in the preoperative stages, a highly precise 3-D map of the eye is generated, detailing higher and lower order aberrations (HOAs/LOAs) in the eye. The wavefront capture provides an accurate assessment of the eye and allows the surgeon to tailor the excimer laser, and, rather than applying a sphero-cylindrical correction to the cornea, the laser is instructed to ablate a sophisticated spatially variant pattern based on measurements from an aberrometer. No longer restricted to measuring sphere and cylinder, wavefront aberrometers can now quantify other types of aberrations that can impair vision, such as coma and spherical aberration. Using these devices, we are gaining a much better appreciation of the optical characteristics of the eye and that allow the treatment of refractive errors in the form of wavefront-guided laser-assisted in situ keratomileusis (LASIK).
- Phoropter method of refraction: measurement of refractive errors is reduced to one single data point Higher order errors can not be assessed Wavefront method of refraction: measurement of refractive errors using over 1,200 data points Lower and Higher order refractive errors are assessed
- The iDESIGN System is smart technology that creates an intricate, personalized map of your eye The technology behind the iDESIGN System was originally developed for high-powered telescopes to view distant objects in space. Working like a computer “brain,” the iDESIGN System takes 5 different types of measurements of the eye to create a detailed picture of the eye’s imperfections. These measurements give your doctor a representation of the patient’s vision, based on the behavior of light waves. This device compares the behavior of light passing through the eye to the behavior of light as it would pass through an ideal eye without nearsightedness or astigmatism This personalized, detailed picture is unique to each patient – just like a fingerprint, no two are alike Your doctor develops a 100% personalized treatment plan based on these comprehensive measurements.
- The iDESIGN system can capture the shape of the cornea; its curvature/power; the ocular wavefront; a patient's refraction (how light passes through the eye); and pupil diameter under different lighting conditions − all in one scan of the eye. Wavefront refraction measures the refractive error of the patient - more reproducible (repeatable) than the manifest refraction – where the patient gives input, subjective Wavefront aberrometry measures refractive aberrations of the eye, detects the higher order aberrations in the eye. Complex aberrations include distortions such as coma, trefoil, and spherical aberration, as well as numerous others that cannot be adequately corrected through spectacle lenses. Keratometry measures the curvature of the anterior surface of the cornea. Corneal topography – map gives information about the shape of the cornea. Pupillometry measures pupil diameter under controlled scotopic and photopic lighting conditions. By providing more high-quality measurements, the iDESIGN system improves iris registration – maximizing the chances for successful iris registration. The iDESIGN system takes an image of the patient’s iris and notes up to 24 identifying marks. This image is transferred with the treatment plan to the excimer laser. The patient’ s eye rotates when moving from sitting to lying down so the excimer laser rotates the treatment to ensure it is positioned correctly.
- Your LASIK procedure just got smarter, giving you the freedom to live hassle-free from contacts or glasses The iDESIGN System captures more data than ever before, creating a detailed picture of your eye’s unique imperfections and accurately plans a treatment that’s 100% personalized With its outstanding accuracy, iDESIGN System can help correct a broader range of astigmatism (up to -5D) in people with nearsightedness. iDESIGN System driven LASIK results in clearer, sharper vision you will enjoy day and night