FDA Approves iDESIGN® Advanced WaveScan Studio System to Treat Hyperopia with and without Astigmatism
The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has approved a new indication for the Star S4 IR® Excimer Laser System and iDESIGN® System. This system can now be used for LASIK patients with hyperopia, with and without astigmatism. Hyperopia, also known as farsightedness, is a common type of refractive error where distant objects may be seen more clearly than objects that are near. However, people experience hyperopia differently. For people with significant hyperopia, vision can be blurry for objects at any distance, near or far.[1]
iDESIGN® System Now Offers a Full Range of Treatments
In addition to myopia and mixed astigmatism, doctors can now treat hyperopia over a wide range of pupil sizes, and those who are 18 years of age and older. Capturing five different measurements in a single capture sequence, 1)Wavefront aberrometry; 2) Wavefront refraction; 3) Corneal topography; 4) Keratometry; and 5) Pupillometry – the iDESIGN® System can help save time during the procedure.
“With its five-measurement capture sequence and high-definition sensor, the iDESIGN® System creates an individualized treatment plan for each patient,” said Dr. Jay Pepose. “It’s now capable of treatment for a wider spectrum of patients who may have myopia, mixed astigmatism, or hyperopia. This broad range of treatment in one system will now offer more solutions to more patients.” Dr. Pepose served as a medical investigator for the clinical trial.
This new indication is for wavefront-guided laser assisted in situ keratomileusis (LASIK) for use in patients:
- with hyperopia with and without astigmatism as measured by the iDESIGN® System up to +4.00 D spherical equivalent, with up to 2.00 D cylinder
- with agreement between manifest refraction (adjusted for optical infinity) and the iDESIGN® System refraction as follows:
- 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, and
- with refractive stability (a change of ≤1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).
[1] https://nei.nih.gov/health/errors/hyperopia
###
For more information on safety, please see the indications and important safety information below.
iDESIGN® Advanced WaveScan Studio System and STAR S4 IR® Excimer Laser System
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 Manuals for the STAR S4 IR® Excimer Laser System and iDESIGN® Advanced WaveScan Studio (iDESIGN®) System for a complete listing of Indications and Important Safety Information. INDICATIONS: The STAR S4 IR® Excimer Laser and the iDESIGN® System is indicated for wavefront guided LASIK in patients with myopia as measured by the iDESIGN® System up to -11.00 D SE, with up to -5.00 D cylinder; in patients with hyperopia with or without astigmatism as measured by the iDESIGN® System up to +4.00 D SE, with up to +2.00 D cylinder; and in patients with mixed astigmatism as measured by the iDESIGN® System where the magnitude of the cylinder (1.0 D to 5.0 D) is greater than the magnitude of the sphere, and the cylinder and sphere have opposite signs; with agreement between manifest refraction (adjusted for optical infinity) and the 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 for: patients with collagen vascular, autoimmune, or immunodeficiency diseases, pregnant or nursing women, patients with signs of corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea, patients with symptoms of significant dry eyes, patients whose corneal thickness would cause the anticipated treatment to violate the posterior 250 microns (μm) of corneal stroma, and in patients with 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 systemic diseases likely to affect wound healing, such as autoimmune connective tissue disease, diabetes or an immunocompromised status, have a history of Herpes simplex or Herpes zoster keratitis, have severe allergies or tendency rub their eyes often, have glaucoma, elevated IOP, ocular hypertension or being followed for possible glaucoma (glaucoma suspect), 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, ocular disease, corneal abnormality, 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 myopia and more than 2 years for mixed astigmatism), 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.
©2017 AMO Manufacturing USA, LLC. iDESIGN, iDESIGN Advanced WaveScan Studio, and STAR S4 IR are trademarks owned by or licensed to AMO Manufacturing USA, LLC, its subsidiaries, or affiliates.