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