Does Hyaluronidase permit volume reduction in sub-Tenon anaestehesia? - MLAV for Sub-Tenon's

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001203-19-GB

Enrollment

Registered

2005-08-17

Start date

2005-09-19

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Interventions

Trade Name: Hyalase Product Name: Hyalase Pharmaceutical Form: Powder for injection* Trade Name: Lidocaine 2% Product Name: Lidocaine 2% Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA 1-3 patients Routine cataract surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ASA 4 & 5 patients Previous surgery on specific eye Allergy to Local Anaesthetics Allergy to Hyaluronidase Inability to give consent Patient refusal

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess and quantify if Hyaluronidase permits volume reduction of the local anaesthetic solution used for sub-Tenon's anaesthesia during cataract surgery. Sub-Tenon's local anaesthesia is a well recognized technique in ophthalmic surgery. By injecting local anaesthetic solution in the sub-Tenon's space the eye is numbed and prevented from moving during surgery. Large volumes of solution can cause chemosis which can complicate the surgical field.This can be avoided by reducing the volume of the injection, which then reduces the quality of the block. Addition of Hyaluronidase increases the spread of the block, but can cause allergic reactions. It is not clear whether the ideal block can be achieved by simply increasing the volume of local anaesthetic, which may worsen the surgical field, or adding hyaluronidase and taking the additional, if small, risk of an adverse event. ;Secondary Objective: To quantify the Minimum Local Anaesthetic Volume (MLAV) required for sub-Tenon's injection with and without Hyaluronidase. To assess whether the volume used in the sub-Tenon's injection has any influence on the quality of the surgical field. To assess whether the volume used in sub-Tenon's injection has any correlation with the occurence of side effects especially chemosis and subconjunctival haemorrhage.;Primary end point(s): A blinded third researcher will judge the efficacy of the sub-Tenon’s injection using the Brahma scoring system (Table 1) for eye movement. Effective block Eye movement score of four or less. The next subject will receive a sub-Tenon’s injection with a volume of 1ml less. Ineffective block Eye movement score of five or more. The next subject will receive a sub-Tenon’s injection with a volume of 1ml more. Any patient - participants and non-participants – with an ineffective block will require a second sub-Tenon’s injection of 3ml 2% lidocaine. This second injection is painless since the eye is already numbed by the first injection.	—

Measure

Time frame

Main Objective: To assess and quantify if Hyaluronidase permits volume reduction of the local anaesthetic solution used for sub-Tenon's anaesthesia during cataract surgery. Sub-Tenon's local anaesthesia is a well recognized technique in ophthalmic surgery. By injecting local anaesthetic solution in the sub-Tenon's space the eye is numbed and prevented from moving during surgery. Large volumes of solution can cause chemosis which can complicate the surgical field.This can be avoided by reducing the volume of the injection, which then reduces the quality of the block. Addition of Hyaluronidase increases the spread of the block, but can cause allergic reactions. It is not clear whether the ideal block can be achieved by simply increasing the volume of local anaesthetic, which may worsen the surgical field, or adding hyaluronidase and taking the additional, if small, risk of an adverse event. ;Secondary Objective: To quantify the Minimum Local Anaesthetic Volume (MLAV) required for sub-Tenon's injection with and without Hyaluronidase. To assess whether the volume used in the sub-Tenon's injection has any influence on the quality of the surgical field. To assess whether the volume used in sub-Tenon's injection has any correlation with the occurence of side effects especially chemosis and subconjunctival haemorrhage.;Primary end point(s): A blinded third researcher will judge the efficacy of the sub-Tenon’s injection using the Brahma scoring system (Table 1) for eye movement. Effective block Eye movement score of four or less. The next subject will receive a sub-Tenon’s injection with a volume of 1ml less. Ineffective block Eye movement score of five or more. The next subject will receive a sub-Tenon’s injection with a volume of 1ml more. Any patient - participants and non-participants – with an ineffective block will require a second sub-Tenon’s injection of 3ml 2% lidocaine. This second injection is painless since the eye is already numbed by the first injection.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026