Femtosecond Lenticule Extraction ( FLEx) and Other Exciting Applications of Femtosecond Lasers- New Approaches to Cornea and Lens Laser Surgery
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2 Carl Zeiss Meditec AG Femtosecond Lenticule Extraction ( FLEx) and Other Exciting Applications of Femtosecond Lasers- New Approaches to Cornea and Lens Laser Surgery Manfred Dick, Hartmut Vogelsang Walter Sekundo, Markus Blum San Francisco, 2008
3 Outline Cornea clinical results: Introduction to the surgical method (FLEX ) prospective FLEX study (ethic commission, clinical investigation plan) FLEX study results of 45 eligible eyes detailed case report Lens experimental investigations: Fs-laser-therapy of presbyopia SOMIT research project Diagnosis of accommodation Experimental investigations for a potential therapy
4 Introduction of the new surgical approach FLEX: Femtosecond Lenticule Extraction New approach for corneal refractive surgery Intracorneal lenticule removal to adjust the refractive properties of the eye Tissue removal instead of tissue ablation Precision of cutting determines predictability of the procedure
5 FLEX - Femtosecond Lenticule Extraction 1. Femtosecond laser pulse 2. Laser processing of the lenticule back side Laser processing of the flap side cut Lenticule removal after flap opening
6 FLEX study design prospective multicenter clinical study in Germany (Mainz, Prof. Walter Sekundo / Erfurt, PD Marcus Blum) controlled by ethics commission Femtosecond system provided by Carl Zeiss Meditec as final prototype version
7 VisuMax Femtosecond lasersystem by Carl Zeiss Meditec
8 FLEX - Femtosecond Lenticule Extraction
9 FLEX - Femtosecond Lenticule Extraction 45 eyes in this interim report Lenticule diameters: 6.0 mm to 7.3 mm adapted to mesopic pupil size Remaining stromal bed > 300 µm Myopia < 8 D (mean SEQ D ± 1.07 D) Myopic astigmatism < 6.0 D cyl Target refraction between 0.0 to D
10 Subject demographics - 45 eligible eyes (22 OS, 23 OD) - 12 males, 13 females Mean Range Age 36.6 y 21 y to 62 y MR SEQ D ± 1.07 D D to D MR Sphere D ± 1.25 D D to D MR Cylinder D ± 1.09 D D to D
11 FLEX Femtosecond Lenticule Extraction Safety Change in BSCVA 100% 90% 80% 70% Percentage [%] 60% 50% 40% 30% 40% 42% 38% 40% 20% 10% 0% month (eyes) 3 m (45) 6 m (42) 13% 7% Change in BSCVA 14% 4%
12 FLEX Femtosecond Lenticule Extraction Refractive outcome
13 FLEX Femtosecond Lenticule Extraction Refractive Outcome Learning curve
14 FLEX Femtosecond Lenticule Extraction Stability
15 FLEX Femtosecond Lenticule Extraction Predictability
16 FLEX Femtosecond Lenticule Extraction Efficacy - UCVA
17 FLEX Femtosecond Lenticule Extraction Adverse events 6 months No adverse events and complications No DLK No TLSS 1 case of mild Haze (6 month post OP) Some eyes with microstriae
18 FLEX Femtosecond Lenticule Extraction Adverse events 6 months 4 cases of suction loss - re-treated - Femto-Lasik - Lasek
19 FLEX Case #1 Pre-Op data and therapy parameters Parameter General Data Value Patient ID E1.9-OD Age 33 years MR D / D / 15 (OD) UCVA pre OP <20/200 BSCVA pre OP 20/20 Therapy Parameters Flap diameter 7.8 mm Flap thickness 150 µm Optical zone diameter 6.5 mm
20 FLEX Case #1 Refractive outcome Target sphere: D Parameter Pre-Op Post-Op (6 Months) MR D / D / D / -0.25D / 25 UCVA <20/200 20/20 BSCVA 20/20 20/20 Result: about 1 D sphere over correction
21 FLEX Case #1 Stability Result: stable refraction despite overcorrection
22 FLEX Case #1 Corneal Topography (axial power) Pre Post (1 M) Post (3 M) Post (6 M) Stable and slightly prolate shape Intended optical zone size was achieved
23 Pre-OP Post-1m Post-6m RMS = 0.34 µm ED < 0.07 D RMS = 0.36 µm ED < 0.07 D RMS = 0.39 µm ED < 0.08 D Very small overall changes, i.e. neutral and very stable
24 FLEX Case #1 Change in Spherical Aberration pre/post-op Result: only very slight induction of SA within the OZ
25 FLEX Femtosecond Lenticule Extraction Summary Prospective clinical data show FLEx to be safe and effective for treatment of myopia Refractive outcome is acceptable for all patients Predictability shows moderate over corrections for lower myopic cases FLEX shows the potential for a new way to achieve aberration neutral myopic treatments
26 Principle of potential fs-lasertherapy of presbyopia BMBF Research Initiative SOMIT Joint Project fs-lasertherapie der Presbyopie FKZ: 13N8829
27 WASCA with binocular accommodation target and a DSA-Software for dynamic data acquisition
28 Visante OCT - Diagnosis of accommodation
29 Visante OCT - Diagnosis of accommodation
30 FEM-results: influence of core hardness Deformation at different core hardness (elongation 0.3 mm) E_core: 1 kpa 4 kpa 16 kpa
31 Experimental setup for lens structuring Lasersystem Scanner Auge
32 Fs-Laser structured lens materials Pig eyes: young, soft core, bubbles Sheep eyes: old (10yr.), hard core, cracks Nearly same threshold for observed effects Optimized Laserparameters no bubbles or cracks therapeutic cuts to create gliding planes inside a lens are possible
33 Thank you for your kind attention!
34
35 Visante OCT - Diagnosis of accommodation
36 Visante OCT - Diagnosis of accommodation
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