1. Intracorneal Inlays for Presbyopia Moderator Ioannis Pallikaris Instructors Stephen Slade John Vukich Dimitrios Bouzoukis Insructional Course 59 19/9/2011

2. FLEXIVUE MICRO-LENS (Presbia) KAMRA (Formerly ACI 7000) (Acufocus) VUE+ (Formerly Presbylens) (ReVision)

3. Flexivue Micro-Lens (Presbia) KAMRA (formerly ACI 7000) (Acufocus) Vue+ (formerly Presbylens) (ReVision) Procedure Modified monovision Mechanism of action Changes the refractive index Increases the depth of focus Changes the anterior corneal curvature Surgery PocketFlap or PocketFlap Stromal Depth 280-300 microns200 microns120 microns Biocompatible YES Inlay Thickness 15-20 microns10 microns20-40 microns Diameter 3.2 mm3.8 mm2 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 INLAYS CHARACHTERISTICS

4. Slit Lamp KAMRA CORNEAL INLAY (ACUFOCUS)

5. 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

6. Inlay Design 8,400 micro- perforations (5-11µ) 8,400 micro- perforations (5-11µ) Pseudo-random pattern Maximize nutrient flow Minimize visual symptoms KAMRA Inlay

7. 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

8. Surgical Procedure PocketFlap KAMRA Inlay

9. VUE+ CORNEAL INLAY (ReVision)

10. 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

11. 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

12. How It Works 12 Inlay Thickness 30 µm Flap Bed Bowman’s Layer Stromal Cushion 100 µm Inlay has same refractive index as cornea but increases curvature in the center of the pupil VUE+ Inlay

13. 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)

14. Diameter: 3mm Peripheral zone with refractive power Peripheral zone with refractive power: +1,25D to +3,00D Central zone without refractive power Thickness: 20μm Inlay Design FLEXIVUE MICRO-LENS Inlay

15. 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

16. There is a central myopic effect only when we analyze the 3,5mm zone. The concept of “Smart Monovision” Preop 3 months Post – Inlay Seidel Sphere -0.34 Cylinder -0.50 X 160 5.0 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 FLEXIVUE MICRO-LENS Inlay Near Far

17. 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

18. 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 iFS 150 FLEXIVUE MICRO-LENS Inlay