This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Wavelight ALLEGRETTO WAVE® Eye-Q Excimer Laser System
PMA Applicant: Alcon Research, Ltd.
Address: 6201 South Freeway, Fort Worth, Texas 76134
Approval Date: September 27, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020050s012a.pdf
What is it? The Wavelight ALLEGRETTO WAVE® Eye-Q Excimer Laser System is an ophthalmic laser system for refractive surgery of the cornea designed to correct the vision of patients with a variety of refractive errors (nearsightedness or farsightedness with or without astigmatism) by Laser Assisted In-Situ Keratomileusis (LASIK).
How does it work? LASIK uses an excimer laser to permanently change the shape of the cornea, the clear covering of the front of the eye. A thin flap is cut from the cornea and a hinge is left at one end of this flap. The flap is folded back revealing the corneal stroma, the middle section of the cornea. Pulses from the laser remove a portion of the stroma and then the flap is replaced.
In the previous approval for Wavefront-guided LASIK (P020050/S4), the planned pattern of laser pulses was based on the degree of nearsightedness or farsightedness, which is measured by (1) assessing the natural seeing ability of the eye and (2) using wavefront (e.g., light, ultrasound) technology to map the optical imperfections of the eye. However, this approval uses different hardware (the ALLEGRO Topolyzer) and the associated software (Topography-guided Custom Ablation Treatment, or T-CAT) to plan topography-assisted LASIK treatment. Instead of using wavefront to map the eye, this device maps variations on the surface of the cornea using reflected light. This map (generated by the Allegro Topolyzer) is combined with measures of the natural seeing ability of the eye to determine the pattern of corneal tissue to be removed.
When is it used? This particular device may be used in cases where there are minor variations in the cornea that may not be captured when mapping eye anatomy or when only measuring the natural seeing ability of the eye.
The ALLEGRETTO WAVE® EYE-Q laser system is approved for use in performing Topography-guided LASIK treatments in patients who have nearsightedness with or without astigmatism. You would be a good candidate for Topography-guided LASIK if you are 18 years of age or older and your vision is:
- Up to - 8.0 diopters of nearsightedness, or
- Up to -3.0 diopters of astigmatism, or
- Up to -9.0 diopters nearsightedness with astigmatism; and,
- The amount of nearsightedness with or without astigmatism in your eye did not change by more than 0.5 diopters during the year before your preoperative examination.
What will it accomplish? Even if nearsightedness or farsightedness (with or without astigmatism) is properly corrected, there still may be optical irregularities that can reduce the quality of vision, such as halos and glare. Irregularities in the cornea or in the lens inside the eye may cause distortions in your vision. Wavefront-guided LASIK provides treatment based on irregularities of the whole eye and can leave the cornea more irregular, or “bumpy” than it was before the treatment. Topography-guided LASIK creates a smooth corneal surface and further reduces these irregularities.
When should it not be used? You should NOT have LASIK if any of the conditions below apply. In these cases, the risk of LASIK is greater than the benefit. Therefore LASIK should not be used in:
- Patients with severe dry eye.
- Patients with recurrent corneal erosion.
- Patients with advanced glaucoma.
- Patients with collagen vascular, autoimmune or immunodeficiency diseases.
- Pregnant or nursing women.
- Patients with eyes that have a calculated residual stromal bed thickness that is less than 250 microns.
- Patients with thin and cone-shaped bulging of the cornea (keratoconus), suspected keratoconus, or unstable or irregular central keratometry readings.
- Patients with uncontrolled diabetes.
- Patients with thin corneas or eyes for which preoperative measurement, which contain certain information about irregularities for eye alignment, cannot be obtained.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data (SSED) and labeling are available online.
- NIH - MedlinePlus - Laser Eye Surgery
- FDA's LASIK webpage
- FDA's LASIK webpage, Glossary
- American Academy of Ophthalmology website for LASIK surgery: American Academy of Ophthalmology (AAO) website