Intracorneal Inlays for Presbyopia
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Intracorneal Inlays for Presbyopia
ModeratorIoannis Pallikaris
InstructorsStephen SladeJohn Vukich
Dimitrios Bouzoukis
Insructional Course 59
19/9/2011
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FLEXIVUE MICRO-LENS FLEXIVUE MICRO-LENS (Presbia)(Presbia)
KAMRA (Formerly ACI 7000) KAMRA (Formerly ACI 7000) (Acufocus)(Acufocus)
VUE+ (Formerly Presbylens) VUE+ (Formerly Presbylens) (ReVision)(ReVision)
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Flexivue Micro-Lens(Presbia)
KAMRA (formerly ACI 7000)(Acufocus)
Vue+(formerly Presbylens)(ReVision)
Procedure Modified monovision Modified monovision Modified monovision
Mechanism of actionChanges the refractive index
Increases the depth of focus
Changes the anterior corneal curvature
Surgery Pocket Flap or Pocket Flap
Stromal Depth 280-300 microns 200 microns 120 microns
Biocompatible YES YES YES
Inlay Thickness 15-20 microns 10 microns 20-40 microns
Diameter 3.2 mm 3.8 mm 2 mm
Nutrient flowYES (Central hole)
YES (Micropores)
Yes(Hydrogel permeable material)
FDA ApprovedNO(Clinical trials)
NO (Phase III)
NO (Clinical trials)
CE Mark YES YES YES
INLAYS CHARACHTERISTICS
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Slit Lamp
KAMRA CORNEAL INLAY (ACUFOCUS)
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KAMRA Corneal Inlay• 3.8mm Diameter -
• 5 Microns Thick - 1/10th the Thickness of a Sheet of Paper
• (7.5 mm radius), and Flexible enough to Bend to Different Curvatures without Buckling
• Mass is 71-142 Micrograms - about the Weight of a Salt Crystal
5 microns
AcuFocus Corneal Inlay in profile. KAMRA Inlay
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Inlay Design
8,400micro-
perforations(5-11µ)
Pseudo-random pattern
Maximize nutrient flow
Minimize visual symptoms
KAMRA Inlay
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Optical Principals of Inlay
• Light Rays Pass through the Small Aperture Over a Small Angle, Increasing the Depth of Focus
• Distance Vision is Minimally Affected
3.8mm diameter
1.6mm f22
KAMRA Inlay
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Surgical Procedure
Pocket Flap
KAMRA Inlay
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VUE+ CORNEAL INLAY (ReVision)
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Optical Principals of Inlay
• Light Rays Pass through the Small Aperture Over a Small Angle, Increasing the Depth of Focus
• Distance Vision is Minimally Affected
3.8mm diameter
1.6mm f22
VUE+ Inlay
Inlay Design
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Presbyopic Corneal MicroLens
Product Overview
• Hydrogel corneal microlens implanted after creating a femtosecond flap
• Restores near and intermediate vision in patients with myopic, hyperopic, and emmetropic presbyopia
• Transparent, biocompatible and mimics a healthy cornea
• Removal with reversible vision
11
2 mm diameter, ~30 μm thickness
VUE+ Inlay
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How It Works
12
Inlay Thickness30 µm Flap Bed
Bowman’s Layer
Stromal Cushion100 µm
Inlay has same refractive index as cornea but increases curvature in the center of the pupil
VUE+ Inlay
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3 Distance
1 Near
2 Intermediate
1 2 3
Corneal Cross-section
1 2 3
Average radial refraction (Tracey)
Refraction map (from Tracey wavefront data)
1
2
3
Optical Design
FLEXIVUE MICRO-LENS CORNEAL INLAY (PRESBIA)
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Diameter: 3mm
Peripheral zone with refractive Peripheral zone with refractive powerpower: +1,25D to +3,00D
Central zone without Central zone without refractive powerrefractive power
Thickness: 20μm
Inlay Design
FLEXIVUE MICRO-LENS Inlay
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Inlay Characteristics
FLEXIVUE MICRO-LENS Inlay
Acts changing the refractive index of the cornea
Donut shape bifocal refractive power
The lens is implanted into the stroma of the cornea on the non-dominant eye, inside a corneal tunnel created using femtosecond laser.
The lens is “Invisible”
Biocompatible hydrophilic material with a central hole to increase more the nutrient flow.
The refractive effect is pupil depended, inreasing during near vision and decreasing during far vision, changing less the far vision in the operated eye than in a classic monovision procedure
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There is a central myopic effect only when we analyze the 3,5mm zone.
The concept of “Smart Monovision”
PreopPreop 3 months Post – Inlay3 months Post – Inlay
Seidel Sphere
-0.34
Cylinder -0.50 X 160
5.0 mm5.0 mm
3.5 mm 3.5 mm
Seidel Sphere
-0.54
Cylinder -0.26 X 167
Seidel Sphere
-0.75
Cylinder -0.36 X 161
Seidel Sphere
-2.05
Cylinder -0.50 X 174
Higher Order Aberrations
Higher Order AberrationsHigher Order Aberrations
Higher Order Aberrations
FLEXIVUE MICRO-LENS Inlay
Near
Far
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iTrace wavefront analysis
UDVA: 20/25, J1
Slit lamp photo and eye image taken from the iTrace.
Inlay centered on visual axis-coincides with pupil center
Refractive map of total ocular aberrations in the area of the inlay. The inlay’s peripheral part creates a myopic effect whilst the central part remains emmetropic FLEXIVUE MICRO-LENS Inlay
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Femto parameters:• iPockets software
– Depth: 280-300– Diameter: 4 mm– Bed energy:0.60-0,70– Spot-Line Sep: 2-2 (or 3-3)– Side cut energy: 1.6-1.7– Side cut angle: 160
• Deactivate pocket• Suction-applanation
Setting of the laser parameters Setting of the laser parameters iFS 150iFS 150
FLEXIVUE MICRO-LENS Inlay