When approved in 2003 as the first new laser in five years, the FDA granted Allegretto the widest approval range ever initially given to a new laser for both myopic and hyperopic vision correction. Since then, the Allegretto system has continued to demonstrate excellent clinical results in the hands of an increasing number of surgeons.
Claims of superior clinical results are supported 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 treatments. In addition, near-sighted patients reported an improvement in sensitivity to light.
- Predictable results are the norm for the Allegretto. More than 90% of patients achieve refraction within 1 diopter of their target correction
At the end of the day, we care most about your visual results. “It’s not about any particular bells and whistles of one laser or another, or about marketing hype — it’s about results,” says Dr. Wallace. “We demonstrated excellent results in our practice with other laser systems prior to incorporating Allegretto. The only reason to make this significant investment in new technology is if the visual results achieved with this laser can be even better than they were before.”
Wavelight Clinical Results
Below are the clinical results of FDA studies on the outcomes of the Allegretto Wave laser. It is important to note, the data shows only single primary treatments (no enhancements). Because no enhancements were allowed in the FDA studies, real-life results (those including enhancements) would be even better, resulting in a higher percentage of 20/20 outcomes.
| Myopia (Nearsighted) Study Number of eyes treated 901 Treatment range approved: Up to -12D Sphere with up to -6D of Astigmatism, Single Treatment Data | |||
| Uncorrected Visual Acuity (%) | |||
| 3 Months | 6 Months | 12 Months | |
| 20/16 or better | 56.58 | 60.61 | 58.33 |
| 20/20 or better | 84.38 | 87.72 | 87.44 |
| 20/25 or better | 92.74 | 94.88 | 94.1 |
| 20/40 or better | 98.03 | 98.34 | 98.87 |
| |||
| Hyperopia (Farsighted) Study Number of eyes treated 290 Treatment range approved: Up to +6D Sphere with up to +5D of Astigmatism, Single Treatment Data | |||
| Uncorrected Visual Acuity (%) | |||
| 3 Months | 6 Months | 12 Months | |
| 20/16 or better | 31.11 | 34.43 | 36.25 |
| 20/20 or better | 68.89 | 67.45 | 67.5 |
| 20/25 or better | 82.67 | 83.02 | 88.75 |
| 20/40 or better | 96.44 | 95.28 | 98.75 |
Further reading:
FDA references relating to the Wavelight Allegretto laser approvals.
