*Clinical trials for mixed astigmatism and hyperopia indications have also yielded similar good results
REFERENCES
1. Myopia US IDE Study 110- IDMY. Additional Patient Reported Outcome Analyses. (N=170 patients).
2. Data on File. Johnson & Johnson Surgical Vision, Inc. 2015. DOF2015OTH0012.
3. FDA P930016 supplements 044, 045, and 048.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for the STAR S4 IR® Excimer Laser System and the iDESIGN™ System
INDICATIONS
The STAR S4 IR Excimer Laser System and the iDESIGN™ Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision, with myopic astigmatism, up to -6.00 D spherical equivalent as measured by iDESIGN Refractive Studio, with cylinder up to -3.00 D, and a minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; with an agreement between manifest refraction (adjusted for optical infinity) and iDESIGN Refractive Studio 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 0.50 D; Cylinder Axis: If either the manifest cylinder entered into the iDESIGN Refractive Studio or the iDESIGN Refractive Studio cylinder selected for treatment is less than 0.50 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.50 D, the axis tolerance is linearly reduced from 15o (0.5 D) to 7.5o (7.0 D or greater) based on the average magnitude of both cylinders. With documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and with a successful preoperative trial of monovision or history of monovision experience. The STAR S4 IR Excimer Laser System and iDESIGN® Advanced WaveScan Studio System/iDESIGN Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: With hyperopia with and without astigmatism as measured by iDESIGN™ Advanced WaveScan Studio System/iDESIGN Refractive Studio up to +4.00 D spherical equivalent, with up to 2.00 D cylinder; with mixed astigmatism as measured by iDESIGN Advanced WaveScan Studio System/iDESIGN Refractive Studio where the magnitude of cylinder (1.0 D to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; with myopia as measured by iDESIGN Advanced WaveScan Studio System/iDESIGN Refractive Studio up to -11.00 D spherical equivalent, with up to -5.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN Advanced WaveScan Studio System/iDESIGN Refractive Studio 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).
CONTRAINDICATIONS
Wavefront-guided LASIK surgery is contraindicated in patients with collagen vascular, autoimmune or immunodeficiency diseases; in pregnant or nursing women; in patients with corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea; in patients with symptoms of significant dry eyes. 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. In patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma; in patients with advanced glaucoma; in patients with uncontrolled diabetes; in patients with documented evidence of a change in manifest refraction of more than +0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. in patients taking medications with ocular side effects. Examples are Isotretinoin (Accutane®) for acne treatment or Amiodarone hydrochloride (Cordarone®) for normalizing heart rhythm.
WARNING AND PRECAUTIONS
Wavefront-guided 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. To reduce the risk of corneal ectasia, the posterior 250 microns (μm) of corneal stroma should not be violated. Please refer to Operator’s Manual for a list of additional Precautions.
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 who has been trained in the calibration and operation of this device.
ADVERSE EVENTS
Prior clinical study of monovision LASIK using the WaveScan WaveFront System aberrometer, supports the safety and effectiveness of iDESIGN driven Monovision LASIK Treatment. Please refer to Operator’s Manual for a list of Adverse Events and complications in clinical studies for Wavefront-guided Monovision in Presbyopic Patients with Low to Moderate Myopia and Wavefront-guided Myopic Astigmatism, Myopia, Mixed Astigmatism and Hyperopia.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for the STAR S4 IR Excimer Laser System and the iDESIGN Refractive Studio for Wavefront-Guided Photorefractive Keratectomy (PRK)
INDICATIONS
The STAR S4 IR Excimer Laser System and the iDESIGN Refractive Studio is indicated for wavefront-guided photorefractive keratectomy (PRK) in patients: with myopia, with or without astigmatism, as measured by iDESIGN Refractive Studio System with spherical equivalent up to -8.00 D, and cylinder up to -3.00 D, with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN Refractive Studio 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, in patients 18 years of age or older; with refractive stability (a change of ≤1.0 D in manifest refraction spherical equivalent for a minimum of 12 months prior to surgery), and with wavefront capture diameter of at least 4 mm.
CONTRAINDICATIONS
iDESIGN System driven PRK surgery is contraindicated in patients with any type of active connective tissue disease or autoimmune disease, in patients with signs of keratoconus, abnormal corneal topography, and degenerations of the structure of the cornea, in patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma, in patients with uncontrolled diabetes, in patients with active eye infection or active inflammation, in patients with recent herpes eye infection or problems resulting from past infection, in patients with significant dry eyes. If the patients have severely dry eyes, PRK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing or interfere with the surface of the eye after surgery. It may result in poor vision after PRK.
WARNING AND PRECAUTIONS
iDESIGN System driven PRK surgery is not recommended in patients have systemic diseases that may affect wound healing, such as controlled autoimmune, or connective tissue disease, or controlled diabetes, have an immunocompromised status or take medications that may result in a weakened immune system such as antimetabolites for any medical conditions or affect wound healing such as Isotretinoin (Accutane®), have a history of Herpes simplex or Herpes zoster keratitis, have glaucoma, In patients with a cardiac pacemaker, implanted defibrillator or other implanted electronic device, have mild to moderate dry eye, have decreased vision in one eye (e.g., amblyopia). Surgeons are reminded that they should instruct the patient to fixate on the Patient Fixation LED during surgery with or without the use of the ActiveTrak System. Please refer to Operator’s Manual for a list of additional Precautions.
PP2023RF4213
