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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


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 trial, myopia patients reported significant improvements in ALL measures of visual functioning and well-being six months postoperatively, inlcuidng:2*

  • Clarity of vision
  • Satisfaction with correction
  • Near vision
  • Far vision
  • Activity limitations
  • Difficulty driving at night

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

FOOTNOTES

*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. 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

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 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.

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