Clincal Results (FDA Clinical Trial Data Summary.pdf)
When it was approved in 2003 as the first new laser in five years, the FDA granted ALLEGRETTO WAVE the widest approval range ever initially given to a new laser for both myopic and hyperopic vision correction. Since then, the results have been astoundingly positive. ALLEGRETTO WAVE has been proven to provide superior clinical results, as shown by the following statistics:
- At one year after treatment, more than 93% of patients said they saw at least as well or better than they had with glasses or contacts before treatment.
- More than 98% of patients achieved 20/40 vision one year after treatment; 20/40 is the level of visual acuity required to pass most driving tests.
- Nearly 60% of near-sighted patients achieved 20/16 vision after one year of treatment.
- Both near- and far-sighted patients reported an improvement in their reaction to bright lights and night driving glare after ALLEGRETTO WAVE treatments. In addition, near-sighted patients reported an improvement in sensitivity to light.
- Predictable results are the norm for the ALLEGRETTO WAVE. More than 90% of patients achieve refraction within 1 diopter of their target correction.
A great source for information about LASIK and questions to ask your physician is the FDA website and the website of the American Society of Cataract and Refractive Surgery.
ALLEGRETTO WAVE expands the boundaries of candidacy for LASIK. However, there are certain people who are less than ideal candidates for LASIK and ALLEGRETTO WAVE. These patients are encouraged to speak with their doctor to find the best vision correction option:
- Your age is under 21. In this case your growth phase has not been fully completed, meaning that your eyes can still change. In that case LASIK is not a good option.
- You are pregnant or nursing. Pregnancy causes changes to your hormone system. This can also cause your vision to change. It is therefore better to wait until your child is born and you have finished nursing.
- Glaucoma or high blood pressure
- Keratoconus a corneal irregularity
- Inflammation of the eye (uveitis, blepharitis or iritis)
- Herpes simplex that has infected your eye
- Previous severe injuries on the eye
- Corneal scars or infections
- Certain medications
- Unstable refraction
- Other diseases of the eye such as AMD, diabetic retinopathy, cataract or others
LASIK is also not recommended for patients with:
- Very large pupils
- Thin corneas
- Dry eye
- Unstable refractive errors
During the consultation with your doctor, please be sure to mention all medications you are taking and any medical conditions you have that might affect the success of laser correction.
Click below to view the PDF of the complete ALLEGRETTO WAVE clinical results for Myopia and Hyperopia.