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Epi-Bowman Keratectomy[E.B.K] with the Epi-Clear*,A new device for corneal epithelial ablation. First 10 treated patients Matsliah Taieb M.D., Ben Nissan.

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Presentation on theme: "Epi-Bowman Keratectomy[E.B.K] with the Epi-Clear*,A new device for corneal epithelial ablation. First 10 treated patients Matsliah Taieb M.D., Ben Nissan."— Presentation transcript:

1 Epi-Bowman Keratectomy[E.B.K] with the Epi-Clear*,A new device for corneal epithelial ablation. First 10 treated patients Matsliah Taieb M.D., Ben Nissan David M.D., Andrew Fink M.D., Yariv Bar-on E.S.C.R.S. Milan 2012 The authors have a financial interest in the subject matter.

2 Purpose Clinical study of a new disposable device for corneal epithelial ablation.

3 Device Single-use device Bio-compatible Polymer Multi-blade geometry with collecting grooves Ergonomic Titanium Handle Ergonomic device holder

4 Methods Group A (EBK) Epi-Clear device – 20 eyes from 10 Myopic patients; – Range sph equivalent; from -1.75dt to -7.25dt – Age Range: from 19 to 27 – 2 eyes EBK enhancements Goup B (PRK ) P.T.K. 35 microns + hockey knife – 89 eyes from 46 Myopic patients ; – Range sph equivalent; from -1.00dt to dt – Age Range: from 18 to 43

5 Patients Non-consecutive cases / same surgeon Wavelight allegretto 400Hz Drugs: – Oxybu-procain dilution with Diclofenac, Dexamethasone, Quinolone, Artificial tears Bandage: – Soft contact lens –(Dispo) Protocol: – Control at D1-D2-D3-D7

6 Clinical Analysis Procedure estimation: – Duration – Handiness Epithelial ablation zone (EAZ) quality : – Debris-free – Round shaped regular borders – Healthy epithelial borders – Retains Integrity of the Bowman’s Membrane Patient recovery – Re-epithelization duration – Pain intensity and number of anesthesic drops used – UCVA – back to activity

7 Surgical Procedure Human eyeAnimation

8 Clinical Results Group A – Epi-Clear Device Group B – Control, Hockey Knife Percentage (%) of patients reporting any kind of pain or discomfort. Maximum pain at daily intervals

9 Epithelium Recovery Time Group A – Epi-Clear Device Group B – Control, Hockey Knife Mean % of epithelium recovery

10 Discussion Procedure – quick, safe and precise – Short learning curve – Mean procedure duration; 10 seconds – Epithelial ablation zone (EAZ) quality – Intact Bowman’s membrane – Free of debris with graduated borders Patient recovery – Functional UCVA seems to be faster with EBK compared to PTK/ASA – Post-operative pain notably reduced compared to PTK/ASA – 95% of the 20 eyes were completely healed 48 hours post-procedure

11 Conclusions The EBK procedure for surface ablation in refractive surgery, seems precise, safe for surgeons to perform. Allows the patient functional UCVA (6/10) within the first 48 hours. Following theses results a multi-center study has begun.


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