Surgical Treatments

With the Bausch & Lomb Zyoptix® Personalized Laser Vision Correction System, your doctor can advance your vision to a new level of precision and clarity. In a clinical study 91.5% of subjects achieved 20/20 or better vision.

Read a brief statement including relevant indications, warnings, precautions and adverse events.

Your eye is as unique as your own fingerprint, with its own special shape and complex characteristics that make it unlike any other. The best treatment is one that is unique to you. To better understand your particular vision and any impairments you may have, the Zyoptix® system maps thousands of data points — giving your doctor a fully detailed, three-dimensional picture of your cornea’s shape and characteristics. Your doctor can then provide a unique treatment for each eye, resulting in personalized vision correction that is as individual as your eye.

Small imperfections in the shape of the eye can cause a scattering of light, which in turn can contribute to vision impairment. This scattering of light forms distinct patterns within the eye known as aberrations. The innovative design of the Zyoptix® personalized laser vision correction system allows your doctor to measure these aberrations, then plan a treatment that exactly matches the eye’s individual vision errors.

How it Measures Up?

The following results are from the U.S. clinical trial of 340 eyes, conducted by Bausch & Lomb (six months after surgery), and submitted to the FDA.

Zyoptix 217z100 Excimer Laser - Brief Statement

INDICATIONS AND INTENDED USES: The Zyoptix® 217z100 System for Personalized Laser Vision Correction is approved to perform wavefront-guided LASIK for the reduction or elimination of myopia with sphere up to -7.00 D and cylinder up to -3.00 D and MRSE less than or equal to -7.50 D at the spectacle plane, in patients who are 21 years of age or older, and in patients with a stable refraction of ± 0.5 diopters (in both cylinder and sphere components) over the past year.

ALTERNATIVES: Wavefront-guided LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), incisional refractive keratotomy (RK), and Conventional LASIK.

CLINICAL EXPERIENCE: Approval of the Zyoptix® 217z100 System for Personalized Laser Vision Correction to perform wavefront-guided LASIK, for reduction or elimination of myopia with sphere up to -7.00 D and cylinder up to -3.00 D and MRSE less than or equal to 7.50 D at the spectacle plane, is based on a clinical trial of 340 eyes (117 spherical eyes and 223 spherocylindrical eyes). All treated eyes were available for analysis of safety at 3 months, and all eyes were followed for 6 months. Accountability at 3 and 6 months was 100.0%. All 340 eyes were evaluated for effectiveness with 100.0% accountability at both 3 and 6 months.

The analysis of data from 340 total eyes treated and based on refractive data at 6 month follow-up examination, found that 99.4 % (338/340) were corrected to 20/40 or better and 91.5% (311/340) were corrected to 20/20 or better visual acuity without spectacles or contact lenses.

The study showed that at the 6-month stability time point: there was a loss of greater than or equal to 2 lines of best corrected vision that can be obtained with spectacles in 1/223 astigmatic myopia eyes and in 1/117 spherical myopia eyes; there were no eyes with astigmatic or spherical myopia with best spectacle corrected visual acuity (BSCVA) worse than 20/25 (if 20/20 or better preoperatively). During the course of study, no eye lost >2 lines of BSCVA and no eye had a BSCVA worse than 20/40.

Long term risks of wavefront-guided LASIK for myopia and myopic astigmatism beyond 6 months have not been studied.

CONTRAINDICATIONS: LASIK surgery is contraindicated in patients with collagen vascular, autoimmune, or immunodeficiency diseases, pregnant or nursing women, in patients with signs of keratoconus or any other condition that causes thinning of the cornea, and in patients who are taking one or both of the following medications: isotretinoin (Accutane), or amiodarone hydrochloride (Cordarone).

WARNINGS: The decision to perform LASIK surgery in patients 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. The safety and effectiveness of the Bausch & Lomb Zyoptix® 217z100 System has NOT been established in patients with these conditions or in patients whose Wavefront-measured pupil size is less than 6.00 mm or greater than 7.00 mm; for treatments greater than -7.00 D spherical myopia, or greater than -3.00 D cylinder, or greater than -7.50D MRSE. LASIK is not recommended in patients with a known history of Herpes Simplex or Herpes Zoster, or in patients who have insulin-dependent diabetes, severe allergies or significant dry eye that is unresponsive to treatment. LASIK is also not recommended in patients whose preoperative corneal thickness would leave less than 250 microns of remaining non-ablated cornea following the laser treatment.

PRECAUTIONS: The safety and effectiveness of the Bausch & Lomb Zyoptix® 217z100 System for Personalized Laser Vision Correction have not been established in patients with ocular disease, corneal abnormality, and pervious corneal surgery or trauma to the intended ablation zone, patients with a prior history of refractive surgery, in patients with corneal neovascularization within 1.0 mm of the ablation zone, or patients under 21. The safety and effectiveness of the Bausch & Lomb Zyoptix® 217z100 System for Personalized Laser Vision Correction have not been established in patients taking hormone replacement therapy or antihistamines who may have delayed re-epithelialization of the cornea following surgery, in patients who are taking sumatripin (Imitrex) for migraine headaches, in patients with a history of glaucoma, for treatment of myopia greater than -7.00 D of sphere, astigmatism greater than -3.00 D, and MRSE greter than -7.50 D at the spectacle plane, in patients with a residual corneal thickness less than 250 microns at the completion of ablation, over the longer term (more than 6 months after surgery), in patients with a history of keloid formation, or in patients with a tendency to form scars. Patients 50 years of age and older may be likely to experience a reduction in predictability of outcomes (as compared to younger patients). The safety and effectiveness of wavefront-guided LASIK surgery has ONLY been established with an optical zone size between 6.0 mm and 7.0 mm with a constant blend zone of 1.5mm. Although the ZyWave® Wavefront System measures the refractive error and wavefront aberrations of the human eyes, including myopia, hyperopia, astigmatism, coma, spherical aberration, trefoil, and other higher order aberrations through fifth order, in the clinical study for this PMA, the average higher order aberration did not decrease after Zyoptix Personalized Vision Correction.

Preoperative evaluation for dry eye should be performed. Patients should be advised of the potential for worsening of symptoms associated with dry eye syndrome post-LASIK surgery.

Pupil size should be evaluated under mesopic conditions, and patients with large mesopic pupils should be advised of the potential for negative effects on optical visual symptoms after surgery such as glare, halos, and difficlty with night driving.

ADVERSE EVENTS: For the correction of myopia with sphere up to -7.00 D and cylinder up to -3.00 D and MRSE less than or equal to -7.50 D at the spectacle plane, the clinical trials showed that the following adverse events occurred in at least 1% of the 340 eyes at any interval up to 6 months post-treatment: debris in the interface (5.3% at 1 month, 2.4% at 3 months and 1.2% at 6 months). The following subjective patient adverse events reported as "significantly worse" occurred in at least a 1% of the subjects at 6 months post final treatment: fluctuation of vision, blurring of vision, glare, halos, dryness and double vision, headache, redness, and night driving difficulty.