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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Gianluca Rubiolini M.D.
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
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)
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
All 619 patientshad 6 & 24 months post within 25± micron frompreop. value
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
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 .
1: NO PAIN
2: LIGHT DISCOMFORT
3 DISCOMFORT AND SOME PAIN
PATIENTS WITH NO DISCOMFORT
PATIENTS WITH NO OR LIGHT
DISCOMFORT : ANSWERS 1 + 2
PATIENTS WITH DISCOMFORT
/PAIN: ANSWERS 3 + 4
PATIENTS WITH SEVERE PAIN
It depends from several subjective factors.
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 .