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Effectiveness of Hyaluronidase as an adjuvant in vitrectomy

Supported by Riemser Arzneimittel AG, Greifswald-Insel Riems, Germany

Schönfeld et al., COPHy, Prague, 2010

Carl-Ludwig Schönfeld1, Florian Pinter2, Matthias Remy2, Anselm Kampik2

1 Eye Hospital Herzog Carl Theodor, Munich, Germany.2 Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.

Prague 4-7 March, 2010

2INTRODUCTION

Hyaluronidase added to regional anesthetics has a depolymerizing effect on hyaluronic acid, but without tangible results except in ocular surgery

(Kallio et al. 2000).

Hyaluronidase has particular advantages in peribulbar anesthesia where it accelerates the absorption of bupivacaine (Nathan et al. 1996).

Majority of clinical studies state significant beneficial effects of Hyaluronidase including:

- earlier onset and more complete anesthesia and akinesia

- less requirement for re-injections

- better surgical conditions

To evaluate the benefits and safety of a Hylase® “Dessau”, in patients undergoing combined cataract extraction + pars plana vitrectomy (PPV) or only PPV.

Schönfeld et al., COPHy, Prague, 2010

3MATERIALS & METHODS

• In a 2-year, prospective, randomized, double-blind, placebo-controlled Phase III clinical study 82 patients were recruited.

• The study was conducted as per good clinical practice (GCP) guidelines.

• The study medication was labelled - German Federal Drug Law (§10 Arzneimittelgesetz, AMG).

• The verum group received a retrobulbar injection of 75 I.E Hyaluronidase in combination with the local anesthetic (bupivacaine 0.75 % 5 ml +

mepivacaine 1% 2 ml), placebo group received anaesthetic only.

• The analgesic action was recorded using a visual analogue scale (VAS).

Schönfeld et al., COPHy, Prague, 2010

4MATERIALS & METHODS Inclusion criteria:

- male and female >18 years

- elective cataract and vitrectomy surgery

- inadequately controlled ocular disease

- no current or previous participation in another clinical trial (last 4 weeks).

Exclusion criteria:

- intolerance to Hyaluronidase

- bovine protein or gelatine preparations

- pregnancy or lactation in female volunteers

- history of local anesthetic complications

- muscular or peripheral nerve diseases.

Schönfeld et al., COPHy, Prague, 2010

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DISCUSSION• Fig. 1 shows that complete anesthesia was achieved within 10-15 minutes after application in 41 patients in the Hylase® “Dessau” and 34 patients (82.9 %) in the placebo group, respectively (p<0.05).

• Tolerability was excellent with no side effects in either groups.

• Explorative data evaluation yielded a superior effect of Hylase in terms of ptosis (10 min) after local anaesthetics.

• Due to incomplete akinesia and pain, Hylase group (7 patients) and placebo group (15 patients) needed an additional anesthetic treatment.

Figure 1: Percentage of patients with complete anesthesia after 10-15 minutes.

Schönfeld et al., COPHy, Prague, 2010

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DISCUSSION

16

0

4

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Hylase Group Placebo GroupIncomplete Akinesia Pain and incomplete AkinesiaPain

Figure 2: Additional supplemental injections of local anesthesia.

Figure 2 shows that with regard to secondary outcome parameters, 9 patients (22%) of the Hylase group and 15 patients (34 %) of the placebo group required additional supplemental injections after 10-15 minutes because of incomplete anesthesia and / or akinesia.

No significant statistical difference was observed with respect to akinesia in any group.

9 (22 %)

15 (34 %)

Num

ber o

f pat

ient

s

Schönfeld et al., COPHy, Prague, 2010

7CONCLUSION For ophthalmosurgery, it is crucial to achieve optimal conditions. This holds

particularly true for vitreoretinal surgery with its delicate procedures.

Tolerability was very good in both groups, and there were no side effects in either group noticed.

Hylase® provided a higher level of patient comfort, without apparent risks.

Compared to placebo, Hylase® substantially enhanced the safety of the operation procedure due to a quicker onset of complete anesthesia and more complete ptosis. Therefore, its addition to the anesthetic regimen in combined cataract and ppV surgery is recommended to provide the best perioperative conditions possible for patient and surgeon.

ACKNOWLEDGEMENTSAuthors thank Dr. Amit Gulati (Department of Research & Development, Eye Hospital Bellevue, Kiel, Germany) for his contributions in this poster.

Schönfeld et al., COPHy, Prague, 2010