Presbyopia 2019 Session III: Extended Depth of …...• Combines diffractive technology from Tecnis...
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Daniel H. Chang, M.D. Empire Eye and Laser Center Bakersfield, California, USA Friday, 13 September, 2019 Presbyopia 2019 Session III: Extended Depth of Focus: New Strategies Synergy: Beyond Symfony
Transcript of Presbyopia 2019 Session III: Extended Depth of …...• Combines diffractive technology from Tecnis...
Daniel H. Chang, M.D. Empire Eye and Laser Center Bakersfield, California, USA
Friday, 13 September, 2019
Presbyopia 2019 Session III: Extended Depth of Focus: New Strategies
Synergy: Beyond Symfony
Financial Disclosures
• AcuFocus: S
• Allergan: C, S
• Carl Zeiss Meditec: C, L, S
• Johnson & Johnson Vision: C, L, S
• Mynosys Cellular Devices: C, S
• Omega Ophthalmics: C, O
!2C: Consultant/Advisor L: Lecture Fees O: Equity/Stock Owner S: Grant Support
Before Symfony…
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Tecnis Multifocal 1-Piece Intraocular Lens (IOL) DFU, Models ZKB00 and ZLB00. Santa Ana, CA. Abbott Medical Optics Inc. Tecnis Multifocal 1-Piece Intraocular Lens (IOL) DFU, Model ZMB00. Santa Ana, CA. Johnson & Johnson Surgical Vision, Inc.
50 cm 40 cm 33 cm
ZKB00 (2.75 add)
ZLB00 (3.25 add)
ZMB00 (4.0 add)
ZCB00
Tecnis Multifocal IOL: Good Distance and Near VA
Symfony…
!4Tecnis Symfony Extended Range of Vision IOL Package Insert
Symfony ZXR00
Monofocal ZCB00
~1 D Tecnis Symfony IOL: Continuous range of VA
Tecnis Multifocal IOL: Good Distance and Near VA
Beyond Symfony…
!5Graphics: Johnson & Johnson Vision
Tecnis Multifocal IOL: Good Distance and Near VA
Tecnis Symfony IOL: Continuous range of VA
Goal: Continuous range of high-contrast VA
from Distance through Near
Beyond Symfony…Synergy!
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Goal: Continuous range of high-contrast VA
from Distance through Near
• Combine diffractive technologies
• Correct chromatic aberration
• Pupil-independent design
Tecnis Multifocal IOL: Good Distance and Near VA
Tecnis Symfony IOL: Continuous range of VA
Graphics: Johnson & Johnson Vision
Beyond Symfony…Synergy!
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Tecnis Multifocal IOL: Good Distance and Near VA
Tecnis Symfony IOL: Continuous range of VA
Images: Johnson & Johnson Vision
Tecnis Synergy IOL: Combines MF and EDOF
technology
Goal: Continuous range of high-contrast VA
from Distance through Near
Beyond Symfony…Synergy!
!8Graphics: Johnson & Johnson VisionTecnis Synergy IOL
Tecnis Synergy & Trifocal IOLs Depth of Focus
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DOF2019OTH4004 – Perez G. Simulated VA of the TECNIS Synergy® IOL and PanOptix IOL. 12 April 2019. DOF2019OTH4005 – Perez G. Simulated VA of the TECNIS Synergy® IOL and AT Lisa Tri IOL. 5 May 2019. DOF2019OTH4006 – Perez G. Simulated VA of the TECNIS Synergy® IOL and FineVision IOL. 5 May 2019.
Tecnis Synergy & Trifocal IOLs Visual Quality in Low Light
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DOF2019OTH4002 – Weeber H. MTF of the TECNIS Synergy OptiBlue IOL, and other lens models. 27 Mar 2019.
Tecnis Synergy & Trifocal IOLs Visual Quality in Low Light
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DOF2019OTH4002 – Weeber H. MTF of the TECNIS Synergy OptiBlue IOL, and other lens models. 27 Mar 2019.
Proof of Concept Clinical Trial
• Multicenter study (12 US sites) - D Chang W Christie - T Clinch S Gollamudi - J Hu L Katzen - J Lehman R Lehman - J Loden J Rudd - M Scott K Solomon
• Prospective, randomized, bilateral, masked - Test: Tecnis Synergy - Control: Tecnis Multifocal +3.25
• Postoperative visits at 1 Month and6 Months
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Tecnis Synergy IOL
Proof of Concept Clinical Trial
• Primary endpoints at 1 Month postop - Monocular distance-corrected intermediate
visual acuity (DCIVA) at 66 cm - Monocular distance-corrected near visual acuity
(DCNVA) at 40 cm - Distance-corrected defocus curves - Contrast sensitivity (mesopic and photopic
conditions) - Spectacle independence
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Tecnis Synergy IOL
Clinical Defocus Curves Distance-Corrected Monocular at 1 Month
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Multifocal (n = 72)
Synergy (n = 76)
0.4 LINE (2 letters)
loss
0.6 LINE gain
1.5 LINE gain
0.4 LINE gain 0.7 LINE
gain
100 cm 66 cm 50 cm 40 cm 33 cm 30 cm 25 cmTecnis Synergy IOL curve shows a broader working distance compared to a multifocal
Clinical Defocus Curves Distance-Corrected Monocular at 1 Month
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Synergy (n = 76)
20/32+
≥ 20/32 from 0 to -3.5 D defocus
20/25+
20/25 from -1.5 to -3.0 D defocus
100 cm 66 cm 50 cm 40 cm 33 cm 30 cm 25 cm
Enables selection of IOL power that optimizes distance
30 cm
33 cm
Clinical Defocus Curves by Pupil Size Distance-Corrected Monocular at 1 Month
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No variation in Tecnis Synergy defocus performance with pupil size
Intermediate Visual Acuity Mean DCIVA at 66 cm
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Visu
al A
cuity
(Log
MAR
)
-0.1
0
0.1
0.2
0.3
0.4
Monocular Binocular
0.13
0.22
0.04
0.10
Synergy (76) Multifocal (72)
1.2 lines p<0.0001
0.9 lines p<0.0001
Statistically significant difference in DCIVA, favoring Synergy
Near Visual Acuity Mean DCNVA at 40 cm
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Visu
al A
cuity
(Log
MAR
)
-0.1
0
0.1
0.2
0.3
0.4
Monocular Binocular
0.04
0.10
0.030.09
Synergy (76) Multifocal (72)
0.01 lines p>0.05
0.01 lines p>0.05
No difference in DCNVA, but Synergy defocus curve >20/25 down to 33 cm
Distance Visual Acuity Mean BCDVA
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Visu
al A
cuity
(Log
MAR
)
-0.1
0
0.1
0.2
0.3
0.4
Monocular Binocular
-0.07-0.04-0.04
-0.00
Synergy (76) Multifocal (72)
0.04 lines p>0.05
0.03 lines p>0.05
No significant difference in BCDVA
Visual Acuity by Distance Mean Best-Corrected
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Visu
al A
cuity
(Log
MAR
)
-0.1
0
0.1
0.2
0.3
0.4
Distance Intermediate Near
0.04
0.13
-0.07
0.030.04
-0.04
Synergy (76) Multifocal (72)
0.03 lines p>0.05
0.01 lines p>0.05
0.9 lines p<0.0001
Monocular DCIVA 1.2 lines
Contrast Sensitivity
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Mesopic without Glare Photopic without Glare
Mesopic with Glare
• Synergy mean contrast sensitivity values within 0.1 log of multifocal control - All spatial frequencies - All conditions
• No variation with pupil size
Spectacle Independence Overall Spectacle Wear at 1 Month
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Perc
ent o
f Sub
ject
s
0%10%20%30%40%50%60%70%80%90%
100%
Synergy (76) Multifocal (72)
13.9%5.3%
81.9%90.8%
None of the timeA little of the timeSome of the timeMost of the timeAll of the time
No significant difference in reported frequency of spectacle wear overall.
Conclusion Tecnis Synergy IOL
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• Combines diffractive technology from Tecnis Multifocal and Tecnis Symfony IOLs - Continuous high-contrast vision: distance, intermediate, and near - Superior low-light contrast
MultifocalSynergy
• DCIVA 1.2 lines better than Multifocal
• DCNVA range much broader than Multifocal
• BCDVA comparable to Multifocal
Conclusion Tecnis Synergy IOL
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• Combines diffractive technology from Tecnis Multifocal and Tecnis Symfony IOLs - Continuous high-contrast vision: distance, intermediate, and near - Superior low-light contrast
MultifocalSynergy
• Excellent NVA up to 33 cm
• Pupil independent defocus and contrast
• Higher proportion reporting NoSpectacle Wear compared to Multifocal
Daniel H. Chang, M.D.
Thank You!
Presbyopia 2019 Session III: Extended Depth of Focus: New Strategies
Synergy: Beyond Symfony
