The document summarizes the benefits and clinical trial results of the iDesign Wavefront aberrometer. It notes that the iDesign features a high definition Hartmann-Shack wavefront sensor that allows for five measurements - wavefront aberrometry, autorefraction, topography, pupillometry, and keratometry - to be captured within a single sequence. A clinical trial of 318 eyes that underwent LASIK using the iDesign found that after 3 months, between 87-90% of eyes achieved 20/20 vision for myopia between -1 to -6 diopters, while 33-72% achieved 20/20 for myopia greater than -6 diopters. The iDesign was shown to provide accurate refractive outcomes within ±0

1. SBK with iDesign
Wavefront
David R. Edmison, MD Focus Eye Centre April 30, 2015

2. iDesign
System key benefits
o High definition sensor maximizes Capture rates
o 5 measurements within a single capture sequence
System clinical trials

3. Advantages of iDesign Wavefront
aberrometry:
o High definition Hartmann-Schack wavefront
sensor maximizes capture rate.
o Higher dynamic range (-16 to +12D sphere,
up to 8D cylinder)
o Five measurements within single capture
sequence.
iDesign Wavefront

4. iDesign Wavefront
High definition Hartmann-Schack wavefront sensor.
o Improved spot quality
o (1257 vs 256)
o Better detection of
o highly aberrated eyes.
iDesign WaveScan
iDesign
WaveScan

5. Five measurements within single capture
sequence.
o Wavefront Guided Aberrometry
o Auto-refraction
o Topography
o Pupillometry
o Keratometry
iDesign Wavefront Guided

6. Five measurements within single capture
sequence.
o Wavefront aberrometry
o Auto-refraction
o Topography
o Pupillometry
o Keratometry
iDesign Wavefront
Hartmann-Schack image

7. Five measurements within single capture
sequence.
o Wavefront aberrometry
o Auto-refraction
o Topography
o Pupillometry
o Keratometry
iDesign Wavefront
Fogging target

8. Five measurements within single capture
sequence.
o Wavefront aberrometry
o Auto-refraction
o Topography
o Pupillometry
o Keratometry
iDesign Wavefront
Axial Map
Elevation Map

9. Five measurements within single capture
sequence.
– Wavefront aberrometry
– Auto-refraction
– Topography
– Pupillometry
– Keratometry
iDesign Wavefront
Five measurements within single capture
sequence.
– Wavefront aberrometry
– Auto-refraction
– Topography
– Pupillometry
– Keratometry

10. Five measurements within single capture
sequence.
o Wavefront aberrometry
o Auto-refraction
o Topography
o Pupillometry
o Keratometry
iDesign Wavefront
Superior than Placido Rings (SimK)

11. iDesign SBK Study Cohort
5 SBK Groups (Dec 11, 2013 to Feb 14, 2014)
(n=318 eyes, 59 excluded for Mv = 259 total)
Group n Sph Cyl SE
-1 to -4D SE 134 -3.03 0.82 -2.62
-4 to -6D SE 65 -5.44 0.89 -5.00
> -6D SE 34 -8.03 1.12 -7.47 *
Mixed Astig 15 -1.42 2.00 -0.42
+0.5 to +3D SE 15 1.12 0.92 1.58
* MMC applied for 30 sec

12. Study Cohort
Study Parameters
o All eyes treated by 3 surgeons (DE, CM & JC)
o All with iDesign wavefront + Iris Reg.
o Laser room controlled for T & H
o 95-105µm flaps, 8.5mm or 9.0mm diam.
o MMC 0.02% applied for 30 for <-6 D SE group
Post-op
o BCL x 24hrs
o PF q2h x 24 hrs → qid x 4d → bid x 2d → d/c
o Zymar qid x 1week & lubricants

13. SE(D)
-0.75
-0.50
-0.25
0.00
0.25
0.50
0.75
Avg SE (D) over Time
3M
-1 to -4 D SE, n=134
-4 to -6 D SE, n=65
> -6 D SE, n=34
1M1W
n=131 n=41 n=30
N=64
n=19
n=15
n=34 n=18 n=12
6M 12M
n=119
n=61
n=29
n=165
N=65
n=34

14. SE(D)
-0.75
-0.50
-0.25
0.00
0.25
0.50
0.75
Avg SE (D) over Time
Mixed astig, n=15
+0.5 to +3 D SE, n=15
n=3n=5
n=3n=15
n=5
3M1M1W 6M 12M
n=12
n=15
n=12N=14
n=1
5

15. SBK UCVA (-1 to -4 D SE)

16. SBK UCVA (-4 to -6 D SE)

17. SBK UCVA (> -6 D SE)

18. SBK UCVA (Mixed astig)

19. SBK UCVA (+0.5 to +3 D SE)

20. Predictability at 3 Mths
0
20
40
60
80
100
%ofEyes
+1 to +2 +1 to +0.5 +0.37 to -0.37 -0.5 to -1 -1 to -2
-1 to -4 D SE
-4 to -6 D SE
< -6 D SE
mixed astig
Over response (D) Under response (D)

21. Predictability at 3 Mths
0
20
40
60
80
100
-1 to -2 -0.5 to -1 +0.37 to -
0.37
+1 to +0.5 +1 to +2
%ofEyes
+0.5 to +2 D SE
Over response (D) Under response (D)

22. 3 months Mean SE 20/20 20/25
-1 to -4D SE -0.05 ± 0.16 D 90% 100%
-4 to -6D SE -0.03 ± 0.28 D 87% 95%
> -6D SE -0.38 ± 0.49 D 33% 72%
Mixed astig -0.42 ± 0.58 D 70% 85%
+0.5 to +3D SE -0.14 ± 0.36 D 86% 100%
Nomogram adjustments under study.
– high myopia and mixed.
Need to analyze PRK & Mv results.
Summary
UCVA

23. 3 months 20/20 20/25 20/20 20/25
iDesign WaveScan
-1 to -4D SE 90% 100% 85% 96%
-4 to -6D SE 87% 95% 81% 93%
> -6D SE 33%* 72%* 44% 71%
Mixed astig 70% 85% 65% 80%
+0.5 to +3D SE 86% 100% 69% 85%
Summary
UCVA
* Small sample size

24. THANK YOU