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Wavefront Comparison Chart

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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