E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
ASA 1-3 patients Routine cataract surgery |
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E.4 | Principal exclusion criteria |
ASA 4 & 5 patients Previous surgery on specific eye Allergy to Local Anaesthetics Allergy to Hyaluronidase Inability to give consent Patient refusal
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E.5 End points |
E.5.1 | 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.
Breach of protocol If the protocol is breached for any reason by a patient, the next patient in the study group will receive the same volume as the patient who breached the protocol.
As the patients will be randomised at the start into with and without hyaluronidase groups, two parallel but independent sequential allocations will be used.
Scoring Systems Akinesia will be assessed 5 minutes after the block has been performed by an independent third party. Muscle movement will be scored for the secondary directions of gaze (abduction, adduction, elevation and depression) using a standardised scoring system used by Brahma et al (Table 1). Complete block in each of the extra-ocular muscles will score zero, whereas no block will score 12. Lid movement will be scored separately (Table 2).
Table 1 Degree of Akinesia
Degree of Movement Score Full movement 3 Partial movement 2 Flicker of movement 1 No movement 0
Table 2 Degree of lid movement
Degree of Movement Score Full movement 2 Partial movement 1 No movement 0
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Power analysis shows that 49 subjects will be required in each of the two groups. The end of the trial will be defined by the 98th patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |