1. 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

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 eye
Animation

8. 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

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 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

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.