Intracorneal Inlays for Presbyopia

ModeratorIoannis Pallikaris

InstructorsStephen SladeJohn Vukich

Dimitrios Bouzoukis

Insructional Course 59

19/9/2011

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)

 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

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

8,400micro-

perforations(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

• 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

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

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

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)

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

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

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

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

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