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 – 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.