Richard L. Lindstrom, MD's "Thoughts on Corneal and Lens based Refractive Surgery to Enhance Near Vision in the USA: 2015" presentation from OIS@ASCRS 2015
1. Richard L. Lindstrom, MD
Founder and Attending Surgeon:
Minnesota Eye Consultants
Adjunct Clinical Professor Emeritus:
University of Minnesota: Department of Ophthalmology
Associate Director: Minnesota Lions Eye Bank
Board Member: University of Minnesota Foundation
Visiting Professor: UC Irvine:
Gavin Herbert Eye Institute
2. Acufocus, Inc.
C,I,R
, Abbott Medical Optics, Inc. C,I,, Advanced Refractive Technologies
C
Alcon Laboratories, Inc.
C
, AqueSys C,I Bausch +
Lomb, Inc.
C,I,R
,
Bio Syntrx C,I
Calhoun Vision Inc, C,I Clarity Ophthalmics C,I
,
Clear Sight C,I
, Confluence Acquisition Partners I, Inc. I,
Curveright, LLC I, CXL Ophthalmics, LLC I, EBV Partners C,I
, EGG Basket Ventures C,I,
ELENZA, C, Encore
C,I
Evision Photography, C,I, Evision Medical Laser , I, Eyemaginations, Inc. C,I
, ForSight, C,
Forsight Vision 6, Inc. C
Foresight Venture Fund #3, C,I
, Fziomed I,
Glaukos
Corporation
C,I
, HEAVEN Fund
I
, Healthcare Transaction Services
I,
High Performance Optics
C,I,
Hoya Surgical Optics C , ISTA, C, Lensar C,I
Lifeguard Health, C,I , Lumineyes, Inc. C , Minnesota Eye Consultants, P.A. C,I
,
NASA –Vision for Mars Program,C
Nicox, C
NuLens
C,I
Ocular Surgery News/Slack,
c
, Ocular Optics C,I
Ocular Therapeutix, C,I, Oculeve, Inc. C, ,
Omega Eye Health,C,I, Omeros Corp., C
OnPoint, I, Quest
C,I.R
, Rainwater Healthcare I, Refractec
C,I
, MD, Revision Optics,
I,
Revital Vision C, I,, Schroder Life Science Venture Fund C,1, Sight Path, C, I
3D Vision Systems C,I
, Tearlabs, Inc. C,I, Tracey Technologies C,I
, Transcend
Medical, Inc,
C,I
, True Vision, C,I, Versant
C
Viradax
I
, Vision Solutions Technologies C,I,
*C=Consultant *I= Investor * MD= Medical Director *R= Royalty
THIS PRESENTATION MAY CONTAIN DISCUSSION OF OFF LABEL USE OF FDA APPROVED DRUGS AND/OR DEVICES
“This presentation represents the speaker’s professional experience.”
“Products/procedures not approved by the FDA and off label use of FDA approved products/procedures may be discussed.”
Financial Disclosures
3. Incidence and Prevalence of
Presbyopia/Near Vision Dysfunction
• Universal after the age of 45
• 40% of USA population
• 110-120 million people
• 24% myopic (>-1.00)
• 26% hyperopic (>+1.00)
• 50% emmetropic (+0.875 to -0.875)
• 30% also have astigmatism over 1
diopter
4. A Few Important Concepts:
Accommodation: The eyes dynamic
ability to focus under CNS control
through a range in power of the eye
as the distance to the object being
observed varies. (Usually measured
in diopters or an accommodative
amplitude).
5. A Few Important Concepts:
Depth of Focus: The range in
distance or diopters over which an
individual eye or optical system can
see specific target (usually 20/40
and J3)
6. Monovision Blended Vision:
A. Most popular approach to enhance near vision
worldwide
B. Gives highest quality of vision.
C. Aspheric IOL’s or custom ablation stabilization
preferred by me.
D. Visual target.
1. Distance eye: Plano to -0.50
2. Near eye: -1.25 to -1.75
7. Multifocal Optics
A. Second most popular approach to enhance
near vision with corneal or lens based
refractive surgery worldwide.
B. Multifocal Optics can be refractive,
diffractive, or a hybrid.
C. Multifocal Optics can be distance dominant,
near dominant, or symmetrical.
10. AT LISA TRI / Toric
Add: 3.33 D / 1.66 D
Optic: Aspheric trifocal/ bifocal
diffractive
Material: 25% hydrophilic acrylic
with hydrophobic surface
Filtration: UV blocker
Optic body diameter: 6 mm
Overall diameter: 11 mm
Angulation: -
from +0D to +32D (0.5D steps)
Toric from -10D to +24D (0.5D
steps)
Quellen: Herstellerangaben
12. Trial Physiol Trifocal IOL
N=40 eyes of 20 patients, 6 months follow-up
Cataract surgery
Alio et al, JRS 2013
13. TECNIS® Symfony IOL merges two
complementary enabling technologies
1. Unique echelette design feature extends the range of
continuous vision1
2. Proprietary achromatic technology reduces chromatic
aberration for enhanced contrast sensitivity1
1. TECNIS Symfony DFU
TECNIS® Symfony IOL is not FDA approved for use in the
US
Elongated Focus
Echelette design feature
14. Clinically Significant Increased Range
of Vision( Depth of Focus)With Reduced Halo and Glare
TECNIS®
Symfony IOL delivers:
- Sustained mean visual acuity of 20/20 or
better through 1.5 D of defocus
- Full range of functional (20/40 or better)
vision through 2.5 D of defocus
- Halo and glare levels comparable to that
of a monofocal IOL due to the lack of a
distinct second focus, coupled with
achromat technology
1. 166 Data on File_Extended Range of Vision IOL 3-Month Study
Results (NZ)
1.5 D
Mean VA of 20/20 or
better though 1.5 D of
defocus
2.5 D
VA of 20/40 or better
through 2.5 D of defocus
TECNIS® Symfony IOL is not FDA
approved for use in the US
15. Multifocal LASIK
• Currently there are three
general methods for
Multifocal LASIK
(No method is FDA
approved in the U.S.)
19. AcuFocus KAMRA inlay reduces aperture size and
increases depth of field. The inlay harnesses
useful light and allows only focused rays to reach
the retina through an uninterrupted pathway.
Presbia Flexivue Microlens and Neoptics Icolens
are multifocal optics. The outer zone on both
inlays provides near vision and the central zone
has a neutral power to provide distance vision.
Both inlays come in a range of powers to address
the progression of near vision dysfunction over
time.
ReVision Optics (RVO) Raindrop Near Vision
Inlay increases the steepness of the cornea
centrally to provide near vision.
Current Corneal Inlays
20. Small Aperture Inlay
1.6mm
Aperture
5 μm
thick
Made from
Polyvinylidene
Fluoride
(PVDF)
8,400 holes
(5-11 μm)
Inlay matches corneal
curvature
3.8mm
Diam
Inlay Design
Presbyo
pia
With Inlay
Inlay
Lens cannot
accommodate
Depth of Focus
Inlay in vivo
Image courtesy of Dr.
Minoru Tomita
Shinagawa LASIK Center
21. RVO: Raindrop Near Vision Inlay
Stromal Cushion
100 µm
• Design:
– A 2mm hydrogel inlay
– Create a multifocal cornea
– Proprietary hydrogel is
permeable allowing for
nutrient flow through the inlay
• Surgical Procedure:
– Implanted ~150 microns deep
– Under a corneal flap
• Method of Action:
– Central 2mm provides near
vision
– Results in a 2-3mm central
corneal steepening
– Peripheral cornea provides
distance
– Transition zone provides
intermediate vision
• Patient Candidates:
– Emmetropes
22. Presbia: Flexivue Microlens
Design:
Disc shape bifocal inlay with
refractive power
Central 0.15mm hole for
nutrient flow
Surgical Procedure:
Implanted 280-300 microns
deep
Inserted into a pocket
Method of Action:
Central zone provides
distance vision
Peripheral zone provides
near
Peripheral corneal also
provides distance vision
Patient Candidates:
Ametropes between -1.00D
to +1.50D
Thickness*: 15 µm Diameter: 3.2 mm
Peripheral
zone with
refractive
power: +1.5
D to +3.5 D
Central
zone
without
refractive
power
*Thickness varies based on power
23. Neoptics: Icolens
Design:
Disc shape bifocal inlay with
refractive power
Central 0.15mm hole for
nutrient flow
Surgical Procedure:
Inserted into a pocket
Inlay preloaded into an inserter
Method of Action:
Central zone provides distance
vision
Peripheral zone provides near
Peripheral corneal also
provides distance vision
Patient Candidates:
Ametropes between -1.00D to
+1.50D
Inlay
24. Accommodating IOL’s
A. Third most common approach to lens based refractive
surgery to enhance intermediate and near vision.
B. The mechanism of action of accommodating IOL’s, like
normal accommodation, is multifactorial and includes
increased depth of focus benefits of pseudo-
accommodation and accommodation.
C. Quality of vision issues are significantly less than in a
multifocal IOL, but slightly greater than with an aspheric
monofocal IOL.
(ARMD, glaucoma, previous refractive surgery, etc are
therefore less of an issue.)
25. Built on an Innovative Platform
Crystalens® AO
Oct 2009
AT-45/
AT-45SE
Nov 2003
AT-Five-0
Nov 2006
AT-HD
July 2008
TRULIGN™
Toric IOL
May 2013
o
o
26. FluidVision Lens
Design
6.0 mm optic
diameter
10.0 mm overall
diameter
Haptic height 3.0 mm
RI = 1.48
The optic is
suspended between
the haptics
27. Thought on the Future
A. Monovision/blended vision will remain an attractive
option.
B. Multifocal development is maturing and growth in
use will continue for several years and then plateau.
(2020)
C. Accommodating IOL development is less mature than
multifocal, but advancing steadily and may eventually
dominate. ( 2020)
D. By 2020 Accommodating IOL’s or those that increase
depth of focus will become more popular, but not
completely replace monovision and multifocal optics.