FDA-Approved Outcomes: Results from US Clinical Trials
(with the 200 Hz ALLEGRETTO WAVE)
Results from US clinical trials for wavefront-guided vision correction and comparison to Wavefront Optimized™ correction.
Most important clinical outcomes: WFO (Wavefront Optimized™) & WFG (wavefront-guided) study groups
- 93% of patients achieved UCVA 20/20 or better
- More than 85% of all patients (WFG and WFO) saw at least as good or better without glasses after treatment than before with glasses
- 0% enhancement rate in the WFO group
- 2.7% enhancement rate in the WFG group
- Low contrast acuity improved in patients with significant pre-op RMSh
- No symptomatic increase in aberrations observed after WFO or WFG LASIK
- WFG LASIK proven to reduce aberrations, specifically trefoil and spherical aberrations (patients up to -4 D or more than 0.3 µm RMSh)
- WFO LASIK also reduced aberrations in patients with pre-op RMSh < 0.5 µm
Most important subjective outcomes: WFO (Wavefront Optimized™) & WFG (wavefront-guided) study groups
- At stability, most patients (88.9%) would highly recommend the treatment to a friend, 97.5% would probably or highly recommend it
- Over 90% of patients rated their visual quality good or excellent after treatment (WFG 94.5% / WFO 92%)
Important distinctions in the FDA approval: Custom offset of sphere and cylinder
- The ALLEGRETTO WAVE is the first system to allow a wavefront-guided offset of -3.00 to +1.00 D for sphere and -3.00 to 0.00 D for cylinder.
- Also, the ALLEGRETTO WAVE is the first laser system to allow surgeon adjustment of the cylinder settings.
WaveLight is the only company in the market that has proven the ability to reduce higher order aberrations!