Approval Criteria for Wavefront (Custom) Platforms
Was Not Created Equal
All the information below is based on published data by the FDA.
|
PLATFORMS |
| CRITERIA |
Visx |
Alcon |
Zyoptix (Bausch & Lomb) |
| Range of Approval |
-6.00 Myopia -3.00 Astigmatism -6.50 Combined |
-7.00 Myopia -0.50 Astigmatism |
-7.00 Myopia -3.00 Astigmatism -7.50* Combined
* The widest range |
Cases Performed with Wavefront-Guided (as of 8/03) |
< 10,000 |
< 10,000 |
>100,000 |
Efficacy - Results at 6 months |
20/12.5 - 74% 20/16 - 23%
20/20 - 93% ALL* (260/357**) - 95% Myopia only***
* ALL=includes myopia and astigmatism ** Only 80% of patients that started the trial were available for evaluation *** Not including 12 patients that were excluded because need of retreatment |
20/12.5 - Not reported 20/16 - Not reported
20/20 - 80% Myopia only (111/139) Total 426
20/25 - 91.4% (127/139) |
20/12.5 - 70.3% ALL - 74.4% Myopia only
20/16 - 30% ALL
20/20 - 91.5% ALL - 94% Myopia (340/340)
20/25 - 95.3% ALL
|
Increase of Best Corrected Visual Acuity (more than 1 line on vision chart) |
10.4% |
38% |
80% |
Nighttime driving difficulty compared with before surgery |
Not reported |
19% |
40.3% |
Best Corrected Visual Acuity less than 20/25 after surgery |
0% (0/357) |
0.2% (1/451) |
0% (0/340) |
| Retreatment |
3.4% (12/357) |
None |
None |
Uncorrected Visual Acuity after surgery compared with Best Corrected Visual Acuity before surgery |
70% |
52.6% |
78% |
Contrast sensitivity - ability to differentiate quicker objects at a distance > 2 levels improvement |
Not tested |
> 15.2% Mesopic (semi-dark conditions)
> 2.2% Photopic (better or light conditions) |
> 22.7% Mesopic (semi-dark conditions)
> 24% Photopic (better or light conditions) |
| Higher Order Aberations |
The average HOA did not decrease |
x |
37.5% reduction from baseline |
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