Risks & Benefits
At Cornerstone Eye Associates, patient safety & results are our top priority. While most of our patients are very pleased with their results, like all medical procedures, there are risks involved.
Before undergoing a refractive procedure, you should carefully weigh the risks and benefits based on your own personal value system, and try to avoid being influenced by friends that have had the procedure or doctors encouraging you to do so.
Some patients lose vision. Some patients lose lines of vision on the vision chart that cannot be corrected with glasses, contact lenses, or surgery as a result of treatment.
Some patients develop debilitating visual symptoms. Some patients develop glare, halos, and/or double vision that can seriously affect nighttime vision. Even with good vision on the vision chart, some patients do not see as well in situations of low contrast, such as at night or in fog, after treatment as compared to before treatment.
You may be under treated or over treated. Only a certain percent of patients achieve 20/20 vision without glasses or contacts. You may require additional treatment, but additional treatment may not be possible. You may still need glasses or contact lenses after surgery. This may be true even if you only required a very weak prescription before surgery. If you used reading glasses before surgery, you may still need reading glasses after surgery.
Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.
Results are generally not as good in patients with very large refractive errors of any type. You should discuss your expectations with your doctor and realize that you may still require glasses or contacts after the surgery.
For some farsighted patients, results may diminish with age. If you are farsighted, the level of improved vision you experience after surgery may decrease with age. This can occur if your manifest refraction (a vision exam with lenses before dilating drops) is very different from your cycloplegic refraction (a vision exam with lenses after dilating drops).
Bausch & Lomb Technolas 217A Excimer Laser Important Safety Information
Approval of the premarket approval application supplement is for the TECHNOLAS 217z Zyoptix System for Personalized Vision Correction to perform wavefront-guided LASIK treatments in patients 21 years of age or older for the reduction or elimination of myopia up to 7.00 D sphere with up to -3.00 D of astigmatism and MRSE = 7.50 D at the spectacle plane; and in patients with documented stability of refraction for the 12 months prior to the date of the preoperative examination, as demonstrated by a change of less than or equal to 0.50 D.
Wavefront-guided LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), conventional LASIK, and other refractive surgeries.
Approval of the application 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 timepoint: there was a loss of = 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.
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 rated significantly worse occurred in at least 1% of 340 eyes in the effectiveness cohort at 6 months post-treatment: Fluctuation of vision (4.2%); blurring of vision (3.8%); glare (3.2%); halos (2.6%); dryness and double vision (2.4% each); headache, redness, and night driving difficulty (1.2% each).
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 .875 mm. Long-term risks of wavefront-guided LASIK for myopia and myopic astigmatism beyond 6 months have not been studied.
The safety and effectiveness of the Bausch & Lomb TECHNOLAS 217z Zyoptix System have NOT been established for wavefront-guided surgery 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 -7.50 D MRSE.
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.
Contact our Rochester offices to setup a consultation. We will review your visual goals and discuss whether LASIK is right for you. (877) 470-EYES