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First 10 treated patients Matsliah Taieb MD Ben Nissan David MD Andrew Fink MD Yariv Baron ESCRS Milan 2012 The authors have a financial interest in the subject matter Purpose ID: 228403
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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
E.S.C.R.S. Milan 2012
The authors have a financial interest in the subject matter.Slide2
PurposeClinical study of a new disposable device for corneal epithelial ablation.Slide3
DeviceSingle-use device
Bio-compatible PolymerMulti-blade geometry with collecting groovesErgonomic Titanium Handle Ergonomic device holder Slide4
MethodsGroup 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 272 eyes EBK enhancements
Goup B (PRK) P.T.K. 35 microns + hockey knife89 eyes from 46 Myopic patients ; Range sph equivalent; from -1.00dt to -10.50dtAge Range: from 18 to 43Slide5
PatientsNon-consecutive cases / same surgeon
Wavelight allegretto 400HzDrugs: Oxybu-procain dilution with Diclofenac, Dexamethasone, Quinolone, Artificial tears Bandage:
Soft contact lens –(Dispo) Protocol:Control at D1-D2-D3-D7 Slide6
Clinical AnalysisProcedure estimation:
DurationHandiness Epithelial ablation zone (EAZ) quality :
Debris-freeRound shaped regular bordersHealthy epithelial bordersRetains Integrity of the Bowman’s Membrane
Patient recoveryRe-epithelization duration Pain intensity and number of anesthesic drops used
UCVA – back to activity Slide7
Surgical ProcedureHuman eye
AnimationSlide8
Clinical Results
Group A – Epi-Clear DeviceGroup B
– Control, Hockey Knife
Percentage (%) of patients reporting any kind of pain or discomfort.
Maximum pain at daily intervalsSlide9
Epithelium Recovery Time
Group
A
– Epi-Clear Device
Group
B
– Control, Hockey Knife
Mean % of epithelium recovery Slide10
DiscussionProcedure – quick, safe and precise
Short learning curveMean procedure duration; 10 seconds Epithelial ablation zone (EAZ) quality
Intact Bowman’s membrane Free of debris with graduated bordersPatient recoveryFunctional UCVA seems to be faster with EBK compared to PTK/ASAPost-operative pain notably reduced compared to PTK/ASA95% of the 20 eyes were completely healed 48 hours post-procedureSlide11
ConclusionsThe 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
.