Epi-Bowman Keratectomy[E.B.K] with the Epi-Clear*,new device for corneal epithelial ablation.

Epi-Bowman Keratectomy[E.B.K] with the Epi-Clear*,A new device for corneal epithelial ablation.First 10 treated patientsMatsliah Taieb M.D., Ben Nissan David M.D., Andrew Fink M.D., Yariv Bar-onE.S.C.R.S. Milan 2012The authors have a financial interest in the subject matter.

PurposeClinical study of a new disposable device for corneal epithelial ablation.

DeviceSingle-use deviceBio-compatible PolymerMulti-blade geometry with collecting groovesErgonomic Titanium Handle Ergonomic device holder

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 43PatientsNon-consecutive cases / same surgeonWavelight allegretto 400HzDrugs: Oxybu-procain dilution with Diclofenac, Dexamethasone, Quinolone, Artificial tears Bandage:Soft contact lens (Dispo) Protocol:Control at D1-D2-D3-D7

Clinical AnalysisProcedure estimation:DurationHandiness Epithelial ablation zone (EAZ) quality :Debris-freeRound shaped regular bordersHealthy epithelial bordersRetains Integrity of the Bowmans Membrane Patient recoveryRe-epithelization duration Pain intensity and number of anesthesic drops used UCVA back to activity

Surgical ProcedureHuman eyeAnimation

Clinical ResultsGroup A Epi-Clear DeviceGroup B Control, Hockey Knife

Percentage (%) of patients reporting any kind of pain or discomfort.

Maximum pain at daily intervalsEpithelium Recovery Time

Group A Epi-Clear DeviceGroup B Control, Hockey Knife

Mean % of epithelium recovery DiscussionProcedure quick, safe and preciseShort learning curveMean procedure duration; 10 seconds Epithelial ablation zone (EAZ) qualityIntact Bowmans 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-procedure

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.

Chart11.23.10.62.80.11.800.3

Group AGroup B

1Group AGroup B1 day1.23.12 days0.62.83 days0.11.85 days00.3 , .

Chart13077104301104

Group AGroup B

1Group AGroup B1 day30772 days10433 days0115 days04 , .

Chart10.50.360.750.420.950.7311

Group AGroup B

1Group AGroup BDay 150%36.00%Days 275%42.00%Days 395%73%Days 7100%100% , .