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A study to assess the equivalence in efficacy of anesthesia using topical Proxymetacaine 0.5% drops versus sub-conjunctival Lignocaine 2% (without adrenaline) for subsequent Intravitreal Injections of Ranibizumab (Lucentis): A Randomized Clinical Trial. - IVT Lucentis Anaesthetic Trial

A study to assess the equivalence in efficacy of anesthesia using topical Proxymetacaine 0.5% drops versus sub-conjunctival Lignocaine 2% (without adrenaline) for subsequent Intravitreal Injections of Ranibizumab (Lucentis): A Randomized Clinical Trial. - IVT Lucentis Anaesthetic Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-022644-21-GB
Enrollment
150
Registered
2010-10-08
Start date
2011-01-04
Completion date
Unknown
Last updated
2012-09-03

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

Conditions

Wet Age-related Macular Degeneration

Interventions

Trade Name: Lidocaine Hydrochloride Injection BP 2% w/v. Product Name: Lidocaine Hydrochloride Injection BP 2% w/v. Pharmaceutical Form: Injection* Trade Name: Minims Proxymetacaine hydrochloride 0.

Sponsors

Plymouth Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 50 years or above. Patients receiving subsequent doses of Intra Vitreal Lucentis Injection with a primary diagnosis of wet age related macular degeneration 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: Patients not consenting to be included in the study. Patients on pain medication. Patients undergoing other Intra Vitreal procedure. Patients undergoing Intra Vitreal injection of Ranibizumab for the first time. Patients allergic to any components of the drug used in the study

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the equivalence in effectiveness of topical Proxymetacaine (0.5%) alone as an anaesthetic for Intra vitreal Lucentis injection and to compare it with sub-conjunctival Lignocaine (2%) without adrenaline injection combined with Proxymetacaine using a numeric pain scale.;Secondary Objective: To evaluate the side effect profile of procedure related side effects with topical Proxymetacaine 0.5% and compares it with sub-conjunctival Lignocaine (2%) without adrenaline injection.;Primary end point(s): Primary outcome measures; numeric pain analogue scale test 0.25 hour after the injection and a telephone interview to administering the verbal numeric pain scale to assess overall comfort of the entire procedure.

Countries

United Kingdom

Outcome results

None listed

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