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					New Generation Lens Implants
 Instead of Bifocal Glasses

               AAO Media Update
             San Francisco, CA 2009


          Barry S. Seibel MD
Private Practice, Los Angeles and Beverly Hills, CA
  Clinical Assistant Professor of Ophthalmology
      UCLA David Geffen School of Medicine
Financial Disclosure:

Seibel Instruments from Rhein Medical and
Storz


Phacodynamics, SLACK, Inc.


Consultant: Optimedica, Eyemaginations
Medicare Standard; Prior Art
    Medically significant cataract: prevents
   glasses (or contacts) from giving sufficient
   vision for AODL

    Most patients need glasses for every
   distance (far and near/reading)

    A few have low enough astigmatism for
   POTENTIALLY good vision at one distance
   without glasses, usually far.
Prior Art Option for “Bifocal
Vision”: Monovision
   Only for patients with low astigmatism

    Good Luck with incision size, shape,
   location

   One eye for distance, One eye for near

    Successful only in a minority of contact
   lens patients

    Poor depth perception due to both eyes not
   focussing at the same place at the same
   time
Next Step: Option of
Astigmatism Reduction
  Allows much greater percentage of patients
 the option of either better distance vision
 without glasses, or monovision.

  Facilitated by new technology of corneal
 topography to map astigmatism for
 treatment by Limbal Astigmatic
 Keratotomies or LVC. Machine advances
 and Phacodynamics to reduce
 complications for ALL surgeries.

  Further facilitated by new developments in
 IOL biometry (e.g. partial coherence
 interferometry) for more predictability of eye
 power post-op
Paradigm Shift: “Bifocal” IOLs
      Allow Both Eyes to focus at far and at near
     SIMULTANEOUSLY for more natural vision
     with depth perception

     Two basic designs:

        Diffractive / Refractive: light “bifocally”
       divided into distance and near focus

        Pseudoaccomodative: single focus optic
       designed to shift position in the eye with
       reading muscle effort
Current FDA approved
options


 ReSTOR: diffractive / refractive

 Crystalens: pseudoaccomodative

 Technis Multifocal: diffractive
ReSTOR
  Initial version slightly too close a reading
 distance and sometimes inadequate
 intermediate (computer) vision

  Latest version good reading distance and
 intermediate for most patients

  Glare / Haloes inherent with multifocal
 design: mitigated some by apodization and
 diffractive/refractive design
AcrySof ® IQ ReSTOR® IOL




     SN6AD3
     Add Power: +4.0 D
     Spectacle Plane: +3.2 D
     Range: +10.0 D to +34.0 D
     A-Constant: 118.9

                                 9   2
  Overall Frequency of Spectacle Wear
  (Bilateral comparison)



          100%
           90%                                     IQ ReSTOR® IOL +3.0 D [N=138]
           80%
                                                   IQ ReSTOR® IOL +4.0 D [N=131]
           70%
           60%
           50%
           40%
           30%
           20%
           10%
            0%
                                 Never        Sometimes          Always
                                   How often do you wear eyeglasses?

                                                                    10             33
Source: AcrySof® IQ ReSTOR® IOL Package Insert
                             Spectacle Freedom
                                             Overall Vision
                                                                   AcrySof® ReSTOR® IOL (N=339)
                 100                                               Array (N=99)
                  90                                               Eyeonics (N=128)
                       80                                          SA60AT (N=125)
                  80                                        69.3   69
 % of Subjects




                  70
                  60                                   51

                  50         41

                  40
                                  25.8
                  30                              17
                                                                                         23

                  20                     8                                  3
                                                                                 8 4.7
                  10
                   0
                            Never                  Sometimes                    Always
                                             Overall Spectacle Wear
Comparativ e S&E data
                 U.S. FDA Clinical Trials

                Summary of Results:
                125 patients bilaterally implanted in U.S.


•    94.6 % at one year would choose lens again.

•   87% were 20/25 Near and 20/32 Distance simultaneously.


•   94% were 20/32 (~J2) or better at near


•   84.6% Reported never wearing glasses post surgery.
*note: none of the patients studied had any form of
astigmatic correction pre or post-cataract surgery.

                                                             12
Technis Multifocal

 Diffractive design

 Good distance and near ( ? too close )

 Theoretically most glare of all 3 designs

   Theoretically most reading vision at more
 light levels than other designs
                      Better Reading Speed At Near

• For both dim (6 cd/m2) and bright (100 cd/m2) lighting
  conditions with no correction
  words/minute




Hutz W, et al. J Cataract Refract Surg. 2006;32:2015-2021.
                                                             14   10
Package Insert of Tecnis Multifocal




                                      15
Crystalens
 Pseudoaccommodative

  Initial design somewhat small optic and
 flexibility issues

  Current design larger optic with better
 stability

  Most patients with seamless range of vision
 from distance to intermediate or
 near/intermediate.

 Less glare than multifocal design
   Accommodative IOLs


                                 c m
                             Q ui kTi e™ and a
                                  c
                           G r aphi s decom pr ess or
                                                s c
                       ar e nee ded t o see t h i pi t ur e.




HumanOptics 1CU
                  Eyeonics AT-45
       Photopic Pupillometry and P-C IOL Design




1.2 ++ near / + dist    +- near / ++ dist   + near / ++
dist
       +- /
2.5 + nearint+ dist         +- / +
                        + near int dist         ++int
                                            + near / ++
dist
        +- / ++dist
3.8 +-near int              + int
                        ++ near / + dist        ++
                                            + near /int
++ dist
        +- int               + int                ++
Personal Clinical
Experience
  Matching right technology lens to right
 patient

  Extensive optional testing in biometry to
 achieve results not required when glasses
 are assumed most of the time post-op
 (insurance standard surgery)

  Extensive time evaluating patient goals and
 providing education about realistic function
 of various options, both before first eye AND
 before second eye
Personal Clinical
Experience
  ReSTOR for best chance of most range of
 vision (need bright light / smaller pupil for
 best near vision)

  Crystalens for good range of vision with
 less glare than multifocal designs; also in
 conditions not ideal for multifocals, including
 AMD, corneal non-clarity, etc.

 Technis Multifocal for best reading vision in
 widest range of lighting, including less bright
 conditions
Future Options
  Soonest likely are more
 pseudoaccomodative designs

 Tetraflex similar to Crystalens

  Visiogen Synchrony uses unique dual optic
 design to theoretically give more
 accommodative amplitude (range of vision)
 than single optic designs such as Crystalens
 or Tetraflex. Currently larger incision size.
Future Options


 Adjustable IOL power after implantation;
 Calhoun Vision Light Adjustable Lens

 Femtosecond Laser Assisted Cataract
 Surgery to further reduce complications and
 tighten refractive prediction outcomes
Thank You!

				
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