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Matsliah Taieb M.D., Ben Nissan David M.D., Andrew Fink M.D., Yariv Bar-on

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.

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Matsliah Taieb M.D., Ben Nissan David M.D., Andrew Fink M.D., Yariv Bar-on

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  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 The authors have a financial interest in the subject matter. E.S.C.R.S. Milan 2012

  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 -10.50dt • 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 eye Animation

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

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

  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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