crystalens HD

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Crystalens HD
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Crystalens HDIntroduction

• Multipiece silicone posterior chamber IOL for the
  treatment of cataracts
• Built on the heritage of success of Crystalens
  IOLs

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• Crystalens IOLs are the first and only
  FDA-approved accommodative IOLs

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Crystalens HD Design Enhancement

• Slight increase in negative spherical aberration
  over central 1.5 mm of optic helps improve
  depth-of-focus
• Designed to improve near VA without compromising
  distance VA or contrast sensitivity

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AccommodationMechanism
Fincham. The Mechanism of Accommodation. Br J
Ophthalmol 1937
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AccommodationResearch Findings

• Key studies
• Cramer. Humans (1851)
• Glasser et al. Primates (circa 2004)
• Breen, Dell, Waltz et al. (circa 2005)
• Crystalens study (2006)
• Maximum accommodative power change is in the
  center of the crystalline lens or Crystalens

• Power change
• Greater in the center
• Less in the periphery
• Generally greater than the change in SE
  (refraction)
• Aberration
• Increase in negative spherical aberration
• Increase in coma

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Accommodation Progress in Understanding
Anatomical diagram of accommodative
arching (1937)
Wavefront mapping of accommodative
arching (2006)
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Phakic Accommodation Early Presbyopic Adult
UCDVA 20/20 UCNVA J2
Power change 2.58 D Demand 3.00 D
Pupil size distance 4.20 Pupil size near 4.10
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Phakic Accommodation 11-Year-Old Subject
UCDVA 20/15 UCNVA J1
Power change 1.97 D Demand 2.50 D
Pupil size distance 6.7 Pupil size near 4.8
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Crystalens Accommodation Crystalens Vs Natural
Lens
Natural crystalline lens
Crystalens HD
crystalens
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Crystalens Accommodation3 Years Post-Surgery,
70-Year-Old Subject
UCDVA 20/15 UCIVA 20/20 UCNA J1
Power change 4.81 D Demand 2.50 D
Pupil size distance 3.8 Pupil size near 3.1
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Crystalens HD
Crystalens HD was designed to mimic the central
bulging of a young natural lens consistently
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Lens Comparison
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Crystalens HD50 Magnification
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Crystalens HD Vs Five-O 36 Magnification
Crystalens Five-O
Crystalens HD
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Image Quality
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ONE Point of FocusSimulated Images
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IOL Quality of Vision
? Crystalens HD100 ? Crystalens AT-50SE ?
ReSTOR SN60D3 ? ReZoom ? ReSTOR SN6AD3
NB Resolution of the human eye is between 6 and
20 cycles/mm
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Distance Image Quality under Mesopic Conditions
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Depth of Focus
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Depth of Field
Crystalens HD
AT-45
Wavefront Error
P-V 0.72 RMS 0.57
P-V 0.51 RMS 0.36
Bench Test
Data from Ed Sarver
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Through Focus Study
5 mm pupil
3 mm pupil
Image Sharpness
Image Sharpness
Diopters
Diopters
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3-mm Pupil
Crystalens HD
ReSTOR SA60D3
ReSTOR SN60D3
-1.0 D
-0.5 D
Plano
0.5 D
1.0 D
1.5 D
2.0 D
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5-mm Pupil
Crystalens HD
ReSTOR SA60D3
ReSTOR SN60D3
-1.0 D
-0.5 D
Plano
0.5 D
1.0 D
1.5 D
2.0 D
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Crystalens HD Outcomes
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Crystalens HDEvidence of Effectiveness

• Objective
• To assess the effectiveness of the Crystalens HD
  (HD-100) accommodating IOL in providing near,
  intermediate, and distance vision
• Design
• Eligible patients were screened preoperatively to
  establish a baseline
• Patients underwent small-incision cataract
  surgery with phacoemulsification and a continuous
  circular tear intact capsulorhexis and were
  implanted with Crystalens HD-100 IOL

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Crystalens HDPlatform

• Clinical evaluation was performed on the AT-45
  platform
• The HD will be commercialized on the Five-O
  platform

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InvestigatorsFDA Clinical Trial
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Crystalens HD TrialStudy Parameters

• Visual Acuity (VA)
• Uncorrected
• Near (40 cm), intermediate (80 cm), and distance
  
• Corrected
• Near with distance correction, with and without
  the minimal reading and for the best-corrected
  near VA
• Intermediate with distance correction
• Distance best corrected
• Compared with Crystalens AT-45

• Contrast sensitivity
• Under mesopic conditions with and without glare
• Under photopic conditions without glare
• Compared with Crystalens AT-45 and Five-O

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HD-100 Uncorrected Distance VA
Within 0.50 D of Intended Target Refraction
4-6 Months Postoperatively
Monocular
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HD-100 Uncorrected Intermediate VA
Within 0.50 D of Intended Target Refraction
4-6 Months Postoperatively
Monocular
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HD-100 Uncorrected Near VA
Within 0.50 D of Intended Target Refraction
4-6 Months Postoperatively
Monocular
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Crystalens HD Outcomes

• Comparison with Previous Generation Crystalens
  IOLs

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AT-45, Five-O, and HD-100 Uncorrected Near VA
Within 0.50 D of Intended Target Refraction
4-6 Months Postoperatively
n60
Monocular
Subjects
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AT-45, Five-O, and HD-100 Distance-Corrected
Near VA
Within 0.50 D of Intended Target Refraction
4-6 Months Postoperatively
Monocular
n60
Subjects
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Log Contrast SensitivityMesopic Illumination (3
cd/m2) Without Glare
Log contrast Sensitivity
Spatial Frequency
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Log Contrast Sensitivity Mesopic Illumination (3
cd/m2) With Glare (3 Lux)
Log contrast Sensitivity
Spatial Frequency
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Crystalens HD Outcomes

• Comparisons with Multifocal IOL Clinical Trial
  Outcomes

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FDA Labeling Monocular Distance UCVA
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FDA Labeling Monocular Near UCVA
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FDA Labeling Monocular Intermediate UCVA
Intermediate VA not reported for Tecnis
MF 20/25 or better UCIVA not reported for ReSTOR
MF
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Mean Uncorrected Intermediate VA
20/20
20/25
20/32
20/40
Crystalens HD only tested at 80 cm
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Distance Contrast Sensitivity Mean Photopic
without Glare
Log Contrast Sensitivity
Spatial Frequency
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Distance Contrast Sensitivity Mean Mesopic
without Glare
Log Contrast Sensitivity
Spatial Frequency
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Distance Contrast Sensitivity Mean Mesopic with
Glare
Log Contrast Sensitivity
Spatial Frequency
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Postmarket Results with Crystalens HD

• DataLink Registry Data

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• DataLink is an online registry hosted by
  SurgiVision Consultants, Inc. that is available
  to all Crystalens IOL users
• Crystalens HD (HD) data have been added by new
  and existing Crystalens IOL surgeons
• Includes Crystalens and other presbyopia-correctin
  g IOLs

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Results

• As of March 21, 2009
• Total of 41,538 eyes in the registry
• 4,992 are implanted with Crystalens HD
• This following data are based on Month 1 outcomes

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One Month Data Available
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Refractive PredictabilityMean 1 Standard
Deviation
0.61 D
0.62D
0.55 D
0.52 D
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UCVA Comparisons Binocular Distance UCVA
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UCVA Comparisons Binocular Intermediate UCVA
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UCVA Comparisons Binocular Near UCVA
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Recommendations
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Refractive Target

• The optimal postop refraction is plano to plus in
  the distance eye, plano to minus in the near eye
• IOL power selection anticipates change in
  refraction with healing
• A target of slight plus for the distance eye
• Pick the IOL with the Lowest Plus predicted
  outcome
• Will result in plano or near-plano outcome,
  accounting for slight myopic change in most eyes

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Pre-Operative

• Pre-operative measurements critical to your
  success Accurate IOL Calculation
• Keratometry- Immersion and IOL Master
• Axial Length
• If in doubt or if any of the measurements is
  questionable, take measurements again

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Manage Astigmatism

• Use outcome from first eye to help guide second
  eye selection
• Plan treatment to result in residual cylinder
  amounts of 0.50 D
• Plan refractive correction of preoperative
  cylinder
• Treat any postoperative cylinder, as needed

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IOL Calculation

• Use Holladay II formula
• If axial length is 22.0 mm
• Manufacturers ACD 5.55 mm
• If mean Ks are flatter than 42.00 D or steeper
  than 47.00D, independent of axial length
• For all post-refractive eyes
• Use SRK-T formula
• If axial length is gt22 mm
• A-constant 119.0

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Intra-Operative

• Watertight incisions a must
• Capsulorrhexis size 5.5-6.5 mm
• Right side up insertion of lens
• Hinge open side should be facing the anterior
  part of the eye on implantation
• Positioning the Crystalens HD
• Most surgeons place the haptic at the 1200 and
  600 position at the equator inside the capsular
  bag

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Insertion System
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Crystalsert Insertion System

• Easy, controlled, planar, one-handed lens
  delivery
• Inject through sub-3 mm incision
• Single use, disposable device

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Loading the Crystalsert
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Injector Pearls

• 2.8mm incision size
• DO NOT PUMP THE PLUNGER
• Wound entry at about 45 degrees
• Clear the slits

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Crystalens HDSummary

• First and only FDA-approved accommodating IOL
• Mimics natural focusing action of the eye
• Provides single focal point

• Modified optic increases focal range
• Provides improved near vision versus previous
  generations, without compromise to intermediate
  or distance vision
• No compromise to contrast sensitivity

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Crystalens HD
Thank You