SURGICAL
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MEASURE AND TREAT REFRACTIVE ERRORS IN HIGH DEFINITION

The iDESIGN® System uses proven wavefront acquisition and advanced Fourier algorithms to help create an individualized treatment plan for each and every patient. With its five-measurement capture sequence and high-definition sensor, the iDESIGN® System is the guiding force behind the iLASIK® Technology Suite.

PROVEN TECHNOLOGY

Capture In High Definition

The iDESIGN® System utilizes a high-definition Hartmann-Shack Wavefront sensor, capturing images of outstanding quality.

  • 5x the resolution and 3x the dynamic range of the previous WaveScan WaveFront® System
  • 25x more precise than traditional glasses or contacts measurements
  • Measures up to 1,257 micro-refractions over a 7.0 mm pupil
  • Captures more ocular aberrations unique to every patient’s eye*

Experience Physician Ease Of Use

The iDESIGN® System can help save time during the procedure, capturing five different measurements in a single capture sequence:

  1. Wavefront aberrometry
  2. Wavefront refraction
  3. Corneal topography
  4. Keratometry
  5. Pupillometry

With the convenience of an easy-to-use interface featuring alignment aids,
on-screen tools and seamless integration with the STAR S4 IR®  Excimer Laser,  the iDESIGN® System helps ensure an efficient workflow from start to finish.

PROVEN RESULTS

Deliver Excellent Patient Quality Of Vision

In a clinical trial, myopia patients reported significant improvements in ALL measures of visual functioning and well-being 6 months postoperatively, including:1**

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

Clinical trials for mixed astigmatism and hyperopia indications have also yielded good results.

PROVEN VERSATILITY

Treat a Broad Range Of Patients

The iDESIGN® System is primed to help you treat a wider spectrum of patients compared to the previous WaveScan WaveFront® System.

  • Treats high levels of astigmatism, up to -5.0 diopters
  • Captures a wide range of pupil sizes, from 4.0 to 9.5 mm
  • Allows measurement and treatment planning for patients as young as 18 years old

Measures and treats a number of visual conditions, including:

  • Patients with myopia up to -11.0 diopters SE, with and without astigmatism up to -5.0 D cylinder
  • Patients with hyperopia up to +4.0 diopters SE, with and without astigmatism up to +2.0 D cylinder
  • Patients with mixed astigmatism where the magnitude of cylinder (+1.0 diopters to +5.0 diopters) is greater than the magnitude of sphere, and cylinder and sphere have opposite signs

iDESIGN® Advanced WaveScan Studio System

Measurements

Wavefront aberrometry, wavefront refraction, corneal topography, keratometry, pupillometry

Measurable Range

Sphere and cylinder measurements in 0.01 D increments, spherical equivalent range (6 mm pupil) -16 D to +12 D, cylinder range (6 mm pupil) up to 8.0 D

Approximate
System Size

Length: 0.51 m
Width: 0.46 m
Height: 0.68 m
Weight: 36 kg

FOOTNOTES

*Compared to the Hartmann-Shack sensor in the WaveScan WaveFront® System.

**Results seen using the STAR S4 IR® Excimer Laser.

†System dimensions are only for the optical head and do not include the motorized table.

REFERENCES

1. Food and Drug Administration (FDA). Premarket approval P9300016 S044, S045 and S048.

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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