Insructional Course 59
19/9/2011
Intracorneal Inlays for Presbyopia
Moderator
Ioannis Pallikaris
Instructors
Stephen Slade
John Vukich
Dimitrios Bouzoukis
KAMRA (Formerly ACI 7000)
(Acufocus)
VUE+ (Formerly Presbylens)
(ReVision)
FLEXIVUE MICRO-LENS
(Presbia)
INLAYS CHARACHTERISTICS
Flexivue Micro-Lens
(Presbia)
KAMRA
(formerly ACI 7000)
(Acufocus)
Vue+
(formerly Presbylens)
(ReVision)
Procedure
Modified monovision
Modified monovision
Modified monovision
Mechanism of action
Changes 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 flow
YES
(Central hole)
YES
(Micropores)
Yes
(Hydrogel permeable
material)
FDA Approved
NO
(Clinical trials)
NO
(Phase III)
NO
(Clinical trials)
CE Mark
YES
YES
YES
Slit Lamp
KAMRA CORNEAL INLAY
(ACUFOCUS)
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
Inlay Design
8,400
microperforations(5-11µ)
Pseudo-random
pattern
Maximize
nutrient flow
Minimize visual
symptoms
KAMRA Inlay
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
Surgical Procedure
Pocket
Flap
KAMRA Inlay
VUE+ CORNEAL INLAY
(ReVision)
Optical Principals of Inlay
Inlay Design
• 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
Presbyopic Corneal MicroLens
Product Overview
•
•
•
•
11
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
2 mm diameter, ~30 μm thickness
VUE+ Inlay
How It Works
Stromal Cushion
100 µm
Bowman’s
Layer
Inlay Thickness
30 µm
Flap Bed
Inlay has same refractive index as cornea but
increases curvature in the center of the pupil
12
VUE+ Inlay
Optical Design
1 Near
2 Intermediate
3 Distance
1
2 3
3
2
Refraction map (from Tracey wavefront data)
1
1
Average radial refraction (Tracey)
2 3
Corneal Cross-section
FLEXIVUE MICRO-LENS CORNEAL INLAY
(PRESBIA)
Inlay Design
Thickness: 20μm
Diameter: 3mm
Peripheral zone with refractive
power: +1,25D to +3,00D
Central zone without
refractive power
FLEXIVUE MICRO-LENS Inlay
Inlay Characteristics
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
FLEXIVUE MICRO-LENS Inlay
The concept of “Smart Monovision”
There is a central myopic effect only when we analyze the 3,5mm zone.
FLEXIVUE MICRO-LENS Inlay
3 months Post – Inlay
Preop
3.5 mm
Higher Order Aberrations
Higher Order Aberrations
Seidel Sphere
Seidel Sphere
-0.34
-2.05
Cylinder
-0.50 X 160
Cylinder
-0.50 X 174
Near
Higher Order Aberrations
5.0 mm
Higher Order Aberrations
Far
Seidel Sphere
Seidel Sphere
-0.54
-0.75
Cylinder
-0.26 X 167
Cylinder
-0.36 X 161
iTrace wavefront analysis
UDVA: 20/25, J1
Slit lamp photo and eye image taken
from the iTrace.
Inlay centered on visual axiscoincides 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
Setting of the laser parameters
iFS 150
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
FLEXIVUE MICRO-LENS Inlay