Epi-Bowman Keratectomy[E. B. K] with the Epi-Clear

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Presentation transcript:

Epi-Bowman Keratectomy[E. B. K] with the Epi-Clear 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 The authors have a financial interest in the subject matter. E.S.C.R.S. Milan 2012

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

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

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 -10.50dt Age Range: from 18 to 43

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

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

Surgical Procedure Human eye Animation

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

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

Discussion Procedure – quick, safe and precise Patient recovery 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

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.