USE OF HYALURONIDASE ENZYME IN TOPICAL ANAESTHESIA

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USE OF HYALURONIDASE ENZYME IN TOPICAL ANAESTHESIA

• Gianluca Rubiolini M.D.
• ITALY

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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 GOAL OUR 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
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MATERIALS AND METHODS

• 208 patients (Group A) Ropivacaine 7,5
  Hyaluronidase enzime 30 U.I.
• 202 patients (Group B) Ropivacaine 10
  Hyaluronidase enzime 45 U.I
• 101 patients (Group C) Ropivacaine 7,5 (
  control group)
• 108 patients (Group D) Ropivacaine 10
  control group)
• None of those groups had supplementary
  intracameral
• lidocaine as default.
• Some patients (165) had bilateral (non
  simultaneus) procedure .
• They were always tested with the same
  anaesthesia.
• Surgical procedures all performed by the same
  surgeon facochop iol
• (Eyecryl 4x4 600, Biotech Vision Care )
• Surgical time from 6 minutes to 15 minutes.
• PCO rate similar in all four groups ( min. 7
  max 10) 24 months
• follow up.

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Technical aspects and education for anaesthetic
mix preparation
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Preop postop data

• Corneal Pachimetry
• All 619 patients had 6 24 months post within
  25 micron from preop. value
• Anterior segment
• All 619 had no changes concerning morphology
  and functions of cornea iris/pupil and anterior
  sclera, IOP at 24 months post. op.
• No cases of endophthalmitis or non septic uveitis
  (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.

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Patient post op questionnaire
QUESTION Did you feel any discomfort /pain during the surgical procedure (multiple choice)
QUESTION Did you feel any discomfort /pain during the surgical procedure (multiple choice) 2 I felt light discomfort because of the lights/ touching sensation no pain.
QUESTION Did you feel any discomfort /pain during the surgical procedure (multiple choice) 3 I had a lot of discomfort and sometimes pain I couldnt look at the lights.
QUESTION Did you feel any discomfort /pain during the surgical procedure (multiple choice)
1 No pain /discomfort I could see lights
4 I had sharp pain it was a terrible
experience. Maybe the anaesthesia didnt work
on me .
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PATIENT FEEDBACK
1 NO PAIN 2 LIGHT DISCOMFORT 3 DISCOMFORT AND
SOME PAIN 4SHARP PAIN
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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
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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

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Results

• In groups A and B there were more patients with
  no discomfort ( answer 1 ) comparing groups C and
  D, from 8,9 to 14.4 .
• Considering answers 12 ( no or light dicomfort)
  the difference between groups A-B and control
  groups C-D is more evident from 21.8 to 29,6
• Considering answers n 4 ( terrible/ sharp
  pain), there was a difference between groups A-B
  and C-D from 12,5 to 16,4 increasing, if we
  consider both answers 3 and 4 (severe discomfort
  and pain), from 21,74 to 29,35

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CONCLUSIONS

• Severe discomfort and pain during topical
  cataract surgery can be reduce up 29,35 of the
  cases using Hyaluronidase enzyme added to
  Ropivacaine anaesthetic for topical use with no
  side effects with 24 months follow up.
• Furthermore we found 14,4 more patients with no
  discomfort during surgery just with this topical
  anaesthesia without supplementary intracameral
  lidocaine.
• A multicenter clinical trial is actually
  investigating on long term follow up and time
  related anaesthetic action .