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

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.