Presbytrials Dr. Jeffery Machat

1. Visx Presbyopia trial
TLC Toronto
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2. Study Centers and
Investigators
• University of Ottawa Eye Institute
– W. B. Jackson, MD
– G. Mintsioulis, MD
• TLC, Toronto
– J. Machat, MD
• Image Plus Laser Eye Center
– J. Wiens, MD
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3. Multifocality – What Does it Mean?
• Optics before hyperopic presbyopia treatment
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4. Multifocality – What Does it Mean?
• Modify optics for long depth of focus
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5. VISX Multifocal Treatment
Design
– Central zone provides near correction
– The diameter of the central zone is proportional to the pupil
size (wavefront driven)
– The combination of the central zone, peripheral zone, and
the LASIK flap produces an aspheric curve that expands
the depth of focus
near correction distance correction
25
20
Depth [um]
15
10
5
0
-3 -2 -1 0 1 2 3
Diameter [millimeter]
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6. VISX® Hyperopic Presbyopia
Ablation Profile
Hyperopic-Presby
+2D Hyperope
15
Ablation Profile
10
5
0
-3.5 -2.5 -1.5 -0.5 0.5 1.5 2.5 3.5
Diameter
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7. Corneal Topography Case
Study
• ID#14115: OS
• Pre-Op
– 20/50 uncorrected distance
– J7 uncorrected near
– J5 distance corrected near
• At 3 months
– 20/20 uncorrected distance
– J1 uncorrected near
– J1 distance corrected near
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8. Corneal Topography Case Study
(14115: OS)
2.5 49 2.5 39.41 3 49
38.5 41
40
38
39 40.8387
40.5 39
38 40
38.5
38. 39. 5
4131
31 . 5
9
57
8 54 39. 40. 5
483
40. 0.
4
38
19
0
3 .5 388.
9 5
3 4
2 5 39. 48 2 40 0 48
39. 41.5 41. 55 41
44 .5
0
39
8 00
.8 398
38
3
44
513 .3
58 39
1.5 38. 7 47
1.5 40 41 41.5 .4 47
1
. 51 33
93 91
7 3 31 .5
8 .5 8 46 .4 42 46
1 .5
8
3 41 .
45 1 3
9 4
0. 4 3
1
3 05
. 41 03
0
4 0 4 .53
8 .5 9
54 9 45 .5
42. 5 84
8 45
3 0
.
0.5 . 9 0.5 5 41 4
1 5
9 4
.5 .
3 4 41 5 44
.
1 5
2
44
9 1 8
0
8 4
08 9
3 .
04 3
3 . 043 2 2 4
3 5 3
3 4 15
44
9 89 4 .
8
1
0 41.5 43 0 43
3 4 3
-0.5 8 5 -0.5 9
. . 4
3 .
5 8 42 30
9 5 42
9
0
13 ..4 2
4 8
9 51 42.5 4 5 9
-1 4
0 34
4
3 -1 4 1. 38
.5
3
0. 3 1 4 8
8
.5 .5 41 1 .5 30
4 41
3 9 42
8
37 3 41
-1.5 9 7 -1.5
.5 38
.5 40 4
30
8 40
3 40
.8 .5
3 41.5 41
31
4
9
80 0 38
9 31
4 .5
.01
38 4 44
-2 .5 -2 39.0. 5
39. 4 41 9. 5
33
9
8. 5 39 5 13 39
40. 8
40. 5 7
38 48 3
31
40
9 1 39
8
.5
3 48.3
30 5
39.5 39
41
38
40 40.8387 39
40.5 40 38
38.5
39 40.5
39.4131
Pre-op 3 months post-op
-2.5 38 -2.5 38
-2.5 -2 -1.5 -1 -0.5 0 0.5 1 1.5 2 2.5 -2.5 -2 -1.5 -1 -0.5 0 0.5 1 1.5 2 2.5
• Processed topography maps shows mean curvature
within optical zone area at pre and 3 months
• Post-op central regionAisights
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Jeffery
J.
Machat.
ll
r
steepened as intended

9. Volumetric PSF Simulation
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10. PSF Simulation
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11. Baseline Characteristics
• 75 eyes of 43 hyperopic presbyopic subjects
– Ottawa Eye Institute: 54 eyes of 27 subjects
– TLC, Toronto: 16 eyes of 12 subjects
– Image Plus Laser Eye Center: 5 eyes of 4 subjects
• Pre-Op Refractions
– Sphere: 1.70 D ± 0.58 (range 0.5 to 3.5 D)
– Cylinder: 0.43 D ± 0.35 (range 0.00 to 1.5 D)
• Age: 56 ± 5 (range 47 to 68)
• 60% Female
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12. Monocular Uncorrected
Distance Vision
100 100 100
100 94
92
Percent of Eyes
82
79 79
80
61
60 54
49
44
40 33
20
7
1
0
Pre-Op (n=75) 1 Month (n=71) 3 Months (n=63)6 Months (n=56) 12 Months
(n=34)
20/20 or better 20/25 or better 20/40 or better
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13. Binocular Uncorrected
Distance Vision
100 100 100 100
100 100 100
100 96
Percent of Subjects
88
82 79
80
65
60 56
40
19
20
5
0
Pre-Op (n=37) 1 Month (n=34) 3 Months (n=29) 6 Months (n=24) 12 Months (n=11)
20/20 or better 20/25 or better 20/40 or better
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14. Monocular Uncorrected
Near Vision
100 98
100 97
92 94 91 93
85
Percent of Eyes
80
71
68
64 62
60
40
20
3
0 0
0
Pre-Op 1 Month 3 Months 6 Months 12 Months
(n=75) (n=71) (n=63) (n=56) (n=34)
J1 or better J3 or better J5 or better
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15. Binocular Uncorrected
Near Vision
100 100 100 100 100 100 100 100
97 100
92
Percent of Subjects
100
82
80
60
40
20
8
3
0
0
Pre-Op (n=37) 1 Month (n=34) 3 Months (n=29) 6 Months (n=24) 12 Months (n=11)
J1 or better J3 or better J5 or better
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16. Reading Performance Test
• Functional vision test
measured monocularly
Endpoints:
– Reading Acuity - based on
number of words read
correctly
– Maximum Reading Speed
– Critical print size – smallest
font at which maximum
speed is possible
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17. Reading Performance Results
Pre-op distance-corrected vision compared to post-op
uncorrected vision
Reading Acuity Critical Print Size
98 100
100 100 100
92
Percent of Eyes
Percent of Eyes
100 86 76 68
80
80 48
56 60
60
40
40 8
16 20
20
0
0 Pre-Op w/ 3M w/o
Pre-Op w/ 3M w/o correction correction
correction correction
(n=63) (n=51)
(n=63) (n=51)
J1 or better J3 or better J5 or better
J1 or better J3 or better J5 or better
Maximum Reading Speed was maintained post-operatively
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18. MRSE Over Time
2.50 ± 0.59 Upper 95% CI
1.91 MRSE
MRSE (Diopters)
2.00
Lower 95% CI
1.50
1.00
± 0.71 ± 0.38
0.50 -0.19 ± 0.54 ± 0.41 0.12
± 0.55 -0.04 -0.05
-0.13
0.00
-0.50
-1.00
Pre 1M 3M 6M 9M 12M
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19. 6M Intended vs. Achieved
4.00
Achieved MRSE
3.00
2.00
1.00
0.00
0 1 2 3 4 5
Intended MRSE
73% of eyes are within ±0.5 D of emmetropia at 6M Post-op
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20. 12M Intended vs. Achieved
4.00
3.00
Achieved MRSE
2.00
1.00
0.00
0.00 1.00 2.00 3.00 4.00 5.00
Intended MRSE
82% of eyes are within ±0.5 D of emmetropia at 12M Post-op
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21. Monocular Simultaneous Uncorrected
Distance and Near Vision @ 6 month
1.30
1.10
0.90
0.70
Pre-op (n=56 eyes)
0.50
6 M (n=56 eyes)
J3 or better
0.30
0.10
-0.10
-0.20 -0.10 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90
20/25 or better 77% of eyes achieve both 20/25
distance and J3 near or better
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22. Binocular Simultaneous Uncorrected
Distance and Near Vision @ 6 mth
1.30
1.10
0.90
0.70
J3 or better
0.50 Pre-op (n=24 subjects)
6 M (n=24 subjects)
0.30
0.10
-0.10
-0.20 -0.10 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90
20/25 or better 96% of subjects achieve both 20/25
distance and J3 near or better
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23. Functional Near Vision Scores
Near Score Functional Equivalent
J1+ Medicine Bottle fine print
J1 Street Map Legend
J3 STOCK QUOTES
J5 Newspaper Text
J7 Business Letter (10 pt)
J10 Newspaper Headlines
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24. Questionnaire Results
Satisfaction with Overall Visual Sharpness & Clarity
100
79 80
77
80
Percent of Eyes
60
40
16 17
20 13
8 8
3
0
Satisfied/ Very Not Sure Somewhat/ Very
Satisfied Dissatisfied
Pre-op w/ correction (n= 64) 6M w/o correction (n=53) 12M w/o correction (n=35)
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25. Questionnaire Results
Satisfaction with Distance Vision (Bright)
100 94
89
85
80
Percent of Eyes
60
40
15
20 11
6
0 0
0
0
Satisfied/Very Satisfied Not Sure Somewhat/Very Dissatisfied
Pre-op w/ correction (n=64) 6M w/o correction (n=53) 12M w/o correction (n=35)
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26. Questionnaire Results
Satisfaction with Near Vision (Bright)
100 91
83
Percent of Eyes
80
66
60
40 29
13
20 9
0 4 6
0
Satisfied/Very Satisfied Not Sure Somewhat/Very
Dissatisfied
Pre-op w/ correction (n=64) 6M w/o correction (n=53) 12M w/o correction (n=35)
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27. Questionnaire Results
Satisfaction with Vision at Night
100
85
77
80
Percent of Eyes
67
60
40 30
17
20 11
4 6
3
0
Satisfied/ Very Not Sure Somewhat/ Very
Satisfied Dissatisfied
Pre-op w/ correction(n=64) 6M w/o correction (n=53) 12M w/o correction (n=35)
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28. Questionnaire Results
Spectacle Use
100 100
100
84
Percent of subjects
78 78
80
63
58
60
51
40
20
20
4
0 0 0 0 0
0
Reading Computer Driving Day Driving Night Recreation
Pre-op (n=32) 6 Months (n=27) 12 Months (n=18)
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29. Best Corrected Visual Acuity *
• Distance: loss of > 2 lines
– 3 eyes of 2 subjects at 6M, associated w/ SPK
– 1 eye of 1 subject at 12M
– No eye worse than 20/25-2
• Near: loss of > 2 lines
– 3 eyes of 3 subjects at 6M, associated w/ dry eye
– 2 eyes of 2 subjects at 12M
– No eye worse than J1+
*Under Photopic conditions
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30. 2.50
Dim Contrast Sensitivity
2.00
Pre-Op
1.50
Log Level
1 Month
3 Months
1.00 6 Months
12 Months
0.50
0.00
3 6 12 18
Cycles per Degree
Contrast sensitivity scores are within population norms
for 50-75 year age group (shown in gray)
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31. Summary of Long Term Results
• 96% of subjects achieve simultaneous 20/25
distance vision and J3 near vision at 6M
• Spectacle independence is achieved and
maintained
• Patient satisfaction is good
• Loss of contrast sensitivity within normal limits
• 73% of eyes at 6M and 82% of eyes at 12M
within ±0.5 D of emmetropia
• Follow-up is ongoing
• MyopicProperty
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trials now being conducted

32. Toronto Case Study
S.A.-54 yo
• Pre-op Rx:
O.D. +2.50/-0.50 x 120 20/20
O.S. +2.25/-0.50 x 067 20/20
+2.00 add
Successful bifocal SCL wearer
Surgery done Sept 13/04
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33. Bilateral presbyopic ablation
1 year results
UCVA:
O.D. 20/20-1
plano/-0.25 x 20 20/20
O.S. 20/20+
plano/-0.25 x 180 20/20+
@ 40cm UCVA
O.D.: J3
O.S.: J3
negative SA
O.U.: J1
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34. The information provided in this PowerPoint presentation is
for your personal informational purposes only. It is not
medical advice, medical diagnosis or treatment, or
recommendation for medical care or treatment. All medical
questions or concerns about a medical condition, care,
diagnosis or treatment should be presented to a medical
physician, health care provider, or health care professional.
You acknowledge that your use of this information is at your
sole risk, and that you assume and accept full responsibility
for all risk associated with any reliance upon the information
presented.
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Jeffery
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Machat.
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