use of hyaluronidase enzyme in topical anaesthesia l.
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USE OF HYALURONIDASE ENZYME IN TOPICAL ANAESTHESIA Gianluca Rubiolini M.D. ITALY FINANCIAL DISCLOSURE The Author has no financial interest in the companies that develop, produce and supply those drugs

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Presentation Transcript
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FINANCIAL DISCLOSURE The Author has no financial interest in the companies that develop, produce and supply those drugs
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Cararact surgery is the most common surgical procedure in ophthalmologyAn increasing number of procedures is performed with topical anaesthesia in 2006 ( 61% U.S. 40% EU ).Trends in topical anaesthesia: customizing or standardizing?

OUR GOALOUR KNOWLEDGE

STANDARDIZE OUR “CUSTOM” TOPICAL ANAESTHESIA: we found a positive increase in efficacy and duration adding Hyaluronidase enzyme to Ropivacaine .

None of these drugs were ever used for topical anaesthesia.

Hyaluronidase enzyme should not be directly apply onto the cornea. UNAPPROVED USE

Ropivacaine was never tested for topical use. OFF LABEL USE

materials and methods
MATERIALS AND METHODS

208 patients (Group A) Ropivacaine 7,5% + Hyaluronidaseenzime 30 U.I.

202 patients (Group B) Ropivacaine 10% + Hyaluronidaseenzime 45 U.I

101 patients (Group C) Ropivacaine 7,5% ( controlgroup)

108 patients (Group D) Ropivacaine 10% controlgroup)

None ofthosegroupshadsupplementaryintracameral

lidocaine as default.

Some patients (165) hadbilateral (non simultaneus) procedure .

Theywerealwaystestedwith the sameanaesthesia.

Surgicalprocedures: allperformedby the samesurgeon: facochop + iol

(Eyecryl 4x4 600, Biotech Vision Care )

Surgicaltime: from 6 minutesto 15 minutes.

PCO rate: similar in allfourgroups ( min. 7% max 10%) 24 months

follow up.

preop postop data
CornealPachimetry:

All 619 patientshad 6 & 24 months post within 25± micron frompreop. value

Anteriorsegment :

All 619 had no changesconcerningmorphology and functionsof cornea iris/pupil and anterior sclera, IOP at 24 months post. op.

No casesofendophthalmitis or non septicuveitis (TASS)

Endothelial cells count, 6 months post.op.:

594/619 patients had endothelial cell decrease within 12% from preop. count.

25 patients were not included because of the cataract ( very hard /ambroid).They had more than 12% endothelial cell density decrease.

Preop & postop data
patient post op questionnaire
Patient post op questionnaire

1 No pain /discomfort : I could see lights

4 I had sharp pain : it was a terrible experience. Maybe the anaesthesia didn’t work on me .

patient feedback
PATIENT FEEDBACK

1: NO PAIN

2: LIGHT DISCOMFORT

3 DISCOMFORT AND SOME PAIN

4:SHARP PAIN

patient feedback9
PATIENT FEEDBACK

PATIENTS WITH NO DISCOMFORT

ANSWER 1

PATIENTS WITH NO OR LIGHT

DISCOMFORT : ANSWERS 1 + 2

PATIENTS WITH DISCOMFORT

/PAIN: ANSWERS 3 + 4

PATIENTS WITH SEVERE PAIN

ANSWER 4

critical analysis
CRITICAL ANALYSIS
  • Patients pain classification is not objective.

It depends from several subjective factors.

  • Two answers, no pain and terrible pain , can be considered relatively reliables.
  • Patient preop. preparation and verbal comunication with surgical staff were standardized as much as possible. Anyway some variables cannot be excluded
results
Results
  • In groups A and B therewere more patientswith no discomfort ( answer 1 ) comparinggroups C and D, from8,9% to14.4% .
  • Consideringanswers 1+2 ( no or light dicomfort) the differencebetweengroups A-B and controlgroups C-D is more evident : from21.8% to29,6%
  • Consideringanswersn° 4 ( terrible/ sharppain), therewas a differencebetweengroups A-B and C-D from12,5% to16,4% increasing, ifweconsiderbothanswers 3 and 4 (severe discomfort and pain), from21,74% to29,35%
conclusions

CONCLUSIONS

Severe discomfort and painduringtopicalcataractsurgery can be reduce up 29,35% of the casesusingHyaluronidaseenzymeaddedtoRopivacaineanaestheticfortopicalusewith no side effectswith 24 monthsfollow up.

Furthermorewefound 14,4% more patientswith no discomfortduringsurgery just withthistopicalanaesthesiawithoutsupplementaryintracameral lidocaine.

A multicenterclinical trial isactuallyinvestigating on long termfollow up and timerelatedanaesthetic action .