N/A
N=53
Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01087489 ↗Enrolled (actual)
53
Serious AEs
1.9%
Results posted
Nov 2012
Primary outcome: Primary: Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection — 2.1; 2.09; 1.7; 2.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 4% lidocaine (Drug); 3.5% ophthalmic lidocaine gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Miami VA Healthcare System
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection |
2.1; 2.09; 1.7; 2.0; 4.3; 4.5 | — |
| SECONDARY Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg |
15.5; 15.9; 25.7; 30.9 | — |
| SECONDARY Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage |
3.0; 2.3; 1.9; 1.3 | — |
Summary
Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
Eligibility Criteria
Inclusion Criteria
- Has required repeat Ranibizumab injections and has had at least 3 injections prior to recruitment
- Informed consent
- Age ≥ 18 years
- Clinical need for a therapeutic ranibizumab intravitreal injection regardless of the medical indication
- Able to understand and read English
Exclusion Criteria
- Pregnancy (positive pregnancy test)
- Mental disability
- Prisoners
- Patients with fluctuating or impaired decision-making capacity
- Inability to comply with study or follow-up procedures
- Previous reaction to the same drug class
Data sourced from ClinicalTrials.gov (NCT01087489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.