matteo piovella, md & barbara kusa, md centro di microchirurgia ambulatoriale monza italy dr...

Matteo Piovella, MD & Barbara Kusa, MDCentro di Microchirurgia Ambulatoriale

Monza Italy

Dr Piovella has the following Financial interests or relationships to disclose as consultant:

Abbott Medical Optics INCBD Medical Ophthalmic Systems

Slack INC

How to Seal Clear Cornea Incision After Cataract Surgery: The Role of a Liquid Ocular Bandage

piovella@piovella.com

How To Prepare OcuSeal ™

OcuSeal ™ is a synthetic hydrogel (85% water) packaged as two components: powder and liquid separatelyHydrogel = cross-linked chemical with attached water molecules.

Solution must be used within 30 seconds!piovella@piovella.com

How To Prepare OcuSeal ™ BD Ophthalmic System

piovella@piovella.com

OcuSeal ™ Histologic Study Conclusions

• Biocompatible• Re-epithelialisation: evident• Neovascularization: not evident• Degradation of OcuSeal™: evident

piovella@piovella.com

OcuSeal ™ Chemistry

• 2 active components:– PEG (ester) & PEI (water soluble amine)

• PEG + PEI Cross-linked hydrogel (~30 secs)

• Hydrogel film is spread over patient’s wound• Interacts with underlying tissues • Forms a seal lasting 2-3 days.

– Tissue compliant– Tissue adherent– Elastic (gelatinous)

piovella@piovella.com

Degradation of OcuSeal ™

• Hydrogel: applied on the external surface of the eye, it naturally sloughs off.

• OcuSeal ™ within the wound: naturally degraded by hydrolysis.

• Tissue healing occurs at roughly the same rate of hydrogel degradation, hence the space is taken up by regenerated tissue.

• Degradation by-products are water soluble, and therefore are reabsorbed and excreted through the kidneys.

piovella@piovella.com

OcuSeal™ Clinical Results 79 Eyes

Methods:

• At the end of cataract surgery, 79 cataract surgery patients received OcuSeal ™ liquid bandage for corneal incision sealing ( BD Medical Ophthalmic Systems) .

• 79 patients: 45 males – 34 females

• Mean age: 66.83 ± 11.32 yrs.

• Upon application, OcuSeal ™ liquid bandage cross-links within 30 seconds and forms a smooth, soft and transparent protective barrier film over corneal incisions.

Results:

• No patient discomfort , complications or adverse events were noted during the first three months after application.

• During the learning curve, OcuSeal ™ was not applied correctly in 16 eyes.

• This was due to the fact that the product polymerises in 30 seconds and application onto the cornea was not quick enough .

• The liquid bandage surplus disappears (slit lamp evaluation) in all patients within 12 hours.

piovella@piovella.com

Standard Clear Cornea Incision Vs OcuSeal ™ Use at Day 1 po

No OcuSeal OcuSeal

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piovella@piovella.com

24 Hours After Surgery Patient Foreign Body Feeling OcuSeal™ Use VS OcuSeal™ Unused

OcuSeal™ Use 79 Eyes

Without OcuSeal™ 72 Eyes

BCVA - 79 EYES

Patient Comfort (Foreign Body Feeling) Vs Tissue Adherent Time Waiting Time Before Speculum Removal

(31 Eyes) 30 Secs (29 Eyes) 45 Secs

piovella@piovella.com

Why OcuSeal ™?

• Ease to use• May prevent bacterial inflow• Provides barrier to microbial infection• Long lasting action• Enough for the incision to heal• Degrades as tissue is regenerated• Promotes natural healing• Transparent• Comfortable for the patient

piovella@piovella.com

piovella@piovella.com

OcuSeal ™ Application SurplusOcuSeal ™ Application Surplus Vs Recovery Time for

Smoothly Cornea Surfice – 11 Eyes

0%10%20%30%40%50%60%70%80%90%

100%

100%

Within 12 hrs

Thank you for your attention !