VISION
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PERSONALIZE EVERY PROCEDURE

The STAR S4 IR® Excimer Laser delivers 100% personalized ablation based on the proven wavefront-guided technology of the iDESIGN® System and WaveScan WaveFront® System. Driven by proprietary technology and the versatility to treat a broad range of patients, the STAR S4 IR® Excimer Laser delivers the proven results that provide excellent outcomes for refractive patients.

PROVEN TECHNOLOGY

Powered by the iDESIGN® System’s wavefront-guided measurements, the STAR S4 IR® Excimer Laser performs a customized treatment that includes the eye’s higher-order aberrations. Utilizing Fourier algorithm technology, the laser precisely ablates the eye using 100% of the iDESIGN® System’s data points.

Exclusive technology helps ensure accurate placement of the laser according to surgeon specifications.

  • Iris Registration technology provides a noncontact, automated method to correctly align and center treatment while allowing for instant re-registration in the event of intraoperative movement
  • Variable Repetition Rate (VRR) delivers Fourier-reconstructed shapes with optimized ablation time while minimizing thermal impact on the cornea
  • Variable Spot Scanning (VSS) technology incorporates an array of varying laser pulse diameters to ensure an accurate match between target and ablation shapes
  • ActiveTrak 3-D Active Eye Tracking technology follows the eye’s motions in three dimensions to capture more than 99.4% of eye movements
  • ActiveTrak Automatic Centering technology locates and automatically sets the treatment center in relation to the pupil center

 

VSS Simulation Results1

Systems_VSS_VRR_chart

In a theoretical simulation, the STAR S4 IR® Excimer Laser’s Variable Spot Scanning (VSS) showed consistently more precise ablation than the alternative single spot scanning (SSS) ablation.1

PROVEN RESULTS

The STAR S4 IR® Excimer Laser is primed to deliver exceptional visual quality and patient satisfaction.

In a clinical study where the STAR S4 IR® Excimer Laser and iDESIGN® System worked together, myopic patients reported significant improvements in all measures of visual quality and function:

  • 99% had little to no difficulty participating in active sports or outdoor activities2
  • 99% experienced little to no difficulty with the clarity of their vision2
  • 97% were satisfied with their vision2
  • 93% reported little to no difficulty driving at night2
  • A majority of participants achieved 20/16 or better visual acuity3

PROVEN VERSATILITY

With its broad treatment inclusion criteria, the STAR S4 IR® Excimer Laser allows refractive surgeons to treat a wide range of patients.

Treatment

Refractive Error

Approved Treatment Range

iDESIGN® System Wavefront-Guided LASIK

Myopia

Up to -11.0 D with or without astigmatism up to -5.0 DC (patients 18 years and older)

WaveScan System Wavefront-Guided LASIK

Myopia

Up to -11.0 MRSE with or without astigmatism up to -3.0 DC (patients 21 years and older)

Hyperopia

Up to +3.0 MRSE with or without astigmatism up to +2.0 DC (patients 21 years and older)

Mixed Astigmatism

From +1.0 to 5.0 DC, where cylinder > sphere or of opposite sign (patients 21 years and older)

Conventional LASIK

Myopia

Up to -14.0 D with or without astigmatism from +0.5 to 5.0 DC (patients 18 years and older)

Hyperopia

From +0.5 to 5.0 D with or without astigmatism up to +3.0 DC, with a maximum MRSE of +6.0 D (patients 21 years and older)

Mixed Astigmatism

Up to +6.0 DC, cylinder > where sphere or of opposite sign (patients 21 years and older)

Conventional PRK

Myopia

No more than -6.0 D with no more than +1.0 D of refractive astigmatism (patients 18 years and older)

No more than -12.0 D, with no more than +4.0 D of refractive astigmatism (patients 21 years and older)

Hyperopia

Between +1.0 and +6.0 D, with no more than +1.0 D of refractive astigmatism (patients 21 years and older)

Between +0.5 and +5.0 D with refractive astigmatism from +0.5 to 4.0 D with a maximum MRSE of +6.0 D (patients 21 years and older)

D: Diopter, DC: Diopter cylinder, MRSE: Manifest refraction spherical equivalent.

STAR S4 IR® Excimer Laser

Laser Engine

Class IV laser with 193.0 nanometer output

Pulse Duration

20.0 nanoseconds

Repetition Rate (Standard)

1.5 to 10.0 Hz

Repetition Rate
(CustomVue®
and Advanced
CustomVue®
Procedures)

6.0 to 20.0 Hz

Approximate
System Size

Width: 1.27 m
Length: 2.03 m
Height: 1.49 m
Weight: 726 kg

REFERENCES 

  1. Myopia US IDE Study 110-IDMY. Additional Patient Reported Outcome Analyses. (N=170 patients).
  2. Data on File. Abbott Medical Optics, Inc. 2015.  DOF2015OTH0012.
  3. Clinical studies submitted to FDA via P930016 supplement 044.

INDICATIONS AND IMPORTANT SAFETY INFORMATION STAR S4 IR® LASER AND IDESIGN® ADVANCED WAVESCAN STUDIO SYSTEM

INDICATIONS FOR USE

The STAR S4 IR® Excimer Laser and iDESIGN® Advanced WaveScan Studio (iDESIGN®) System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: with myopia as measured by iDESIGN® System 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® 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). The STAR S4 IR® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan WaveFront® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of myopia and myopic astigmatism from -6.00 to -11.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination.   For the reduction or elimination of myopia and myopic astigmatism up to -6.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.50D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. For the reduction or elimination of hyperopia and hyperopic astigmatism up to 3.00 D MRSE, with cylinder between 0.00 and 2.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination.  For the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of cylinder (from 1 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. Laser assisted in situ keratomileusis (LASIK) procedure using the STAR S4 IR® Excimer Laser System is intended for use: in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components for at least one year prior to the date of preoperative examination; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -14.0 D with or without refractive astigmatism from 0.5 to 5.0D*; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with or without refractive astigmatism up to +3.0 D, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. In patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring mixed astigmatism where the magnitude of cylinder (≤6.0 D at the spectacle plane) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs. Photorefractive Keratectomy (PRK) procedure using the STAR S4 IR® System is intended for use: in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -6.0 D spherical equivalent at the corneal plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -12.0 D spherical myopia at the spectacle plane with no more than 4.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +1.0 and +6.0 D sphere at the spectacle plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with refractive astigmatism from +0.5 to +4.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. Phototherapeutic Keratectomy (PTK) procedures using the STAR S4 IR® System are primarily indicated for subjects with decreased best corrected visual acuity and/or with disabling pain that is the result of superficial corneal epithelial irregularities or stromal scars in the anterior one-third of the cornea. The subjects must have failed alternative treatment options. For safety, the immediate post- operative corneal thickness must not be less than 250 μm. 

CONTRAINDICATIONS

Laser refractive 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. The Phototherapeutic Keratectomy procedure should not be performed if the post-operative thickness would be less than 250 μm (excluding the epithelium and Bowman’s membrane), or if a deep scar is present that is not contained in the anterior one-third of the cornea.

WARNINGS

LASIK is not recommended in patients who: have systemic diseases likely to affect wound healing, such as autoimmune connective tissue disease, diabetes or an immune compromised status; have a history of Herpes simplex or Herpes zoster keratitis; have severe allergies or tendency to 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; lower uncorrected visual acuity may be anticipated in the PRK treatment of higher degrees of myopia with and without astigmatism (>-5.0 D MRSE). Hyperopic shift has been a major safety issue following PTK. It is advisable to ablate only to a depth that is necessary to improve vision and/or relieve symptoms, and not to attempt to remove all scar tissue. Aggressive attempts to ablate all visible scar tissue risk hyperopic shift and corneal ectasia. Subjects should be informed concerning the possibility of hyperopia and subsequent possible induced anisometropia. Reactivation of herpes simplex keratitis has occurred after PTK. A course of oral acyclovir is recommended if there is a history of herpetic infection. If topical steroids are used post-operatively, subjects must be monitored for possible steroid side-effects, such as ocular hypertension and/or glaucoma with subsequent damage to the optic nerve, or development of posterior subcapsular cataract. Subjects with systemic disease likely to affect wound healing, such as connective tissue disease, diabetes, severe atopic disease, or an immunocompromised status should be approached cautiously, as the safety and effectiveness of the excimer system has not been established in patients with these conditions.

PRECAUTIONS

General: Preoperative pachymetry measurement must be performed. To reduce the risk corneal ectasia, the posterior 250 microns (μm) of corneal stroma should not be violated.  There is no safety and effectiveness for any Laser Vision Correction procedure in patients with progressive refractive errors, ocular disease, corneal abnormality, previous corneal or intraocular surgery, trauma in the ablation zone, residual corneal thickness less than 250 microns at the completion of ablation. There is no safety and effectiveness information for patients that are taking the medication Sumatriptan (Imitrex®) and Amiodarone hydrochloride (Cordarone®). Advanced CustomVue LASIK (using iDESIGN® System): 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. The safety and effectiveness of the iDESIGN® System have not been established for wavefront-guided LASIK surgery in patients with corneal neovascularization within 1.0mm of the ablation zone, over the long term (more than 1 year after surgery), or with prior intraocular or corneal surgery of any kind, whose BSCVA is worse than 20/20, whose wavefront measurement diameter is <4mm, for patients who engage in activities that could endanger or damage the LASIK flap. CustomVue LASIK (using WaveScan WaveFront® System): There is no safety and effectiveness information for CustomVue LASIK (using WaveScan WaveFront® System) for more than 1 year after surgery, for prior intraocular or corneal surgery of any kind, or for retreatment. Conventional LASIK (Manifest Refraction): There is no safety and effectiveness information for the patients who have had prior incisional refractive surgery, for patients with hyperopic astigmatism, for more than 6 months after LASIK surgery for myopia with or without astigmatism, hyperopia with or without astigmatism, or mixed astigmatism. PRK: There is no safety and effectiveness information for PRK refractive treatments over the long term, more than 3 years after PRK surgery for low myopia; more than 1 year after PRK surgery for high myopia with astigmatism or for hyperopia with or without astigmatism, patients with a history of keloid formation, patients taking hormone replacement therapy or antihistamines who may have delayed re-epithelialization of the cornea following surgery, PRK retreatment of hyperopic astigmatism. Of the eyes treated in the PRK trials, only 21/200 (10.5%) of highly myopic eyes had myopia between -10.0 and -12.0 diopters and only 13/275 (4.7%) of hyperopic eyes had hyperopia between +4.0 and +6.0 diopters. These populations were not sufficient to determine the level of effectiveness or the complication rates for this refractive error range with the same reliability as for eyes with less severe refractive errors. PTK: The safety and effectiveness of the STAR S4 IR® System has not been established in treatment of recurrent corneal erosions, treatment of corneal disease in eyes with recurrent or active ocular disease such as iritis, uveitis, keratitis sicca, and severe blepharitis, treatment of scars and irregularities in patients with keratoconus, patients with corneal neovascularization near the ablation zone, patients with systemic disease likely to affect wound healing, patients with previous corneal surgery, pregnant women, or patients under 18 years of age. 

ATTENTION

Reference the Operator’s Manual for a complete listing of 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. 

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