N/A
N=28
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00769392 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Discomfort Associated With the Intravitreal Injection — 3; 2.3; 2.8; 3.1 units on a scale — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Proparacaine Ophthalmic (Drug); Tetracaine Ophthalmic (Drug); Lidocaine 4% (Drug); Lidocaine 2% Injectable Solution (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Lahey Clinic
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Discomfort Associated With the Intravitreal Injection |
3; 2.3; 2.8; 3.1 | 0.28 |
| SECONDARY Discomfort From Anesthesia Used Prior to Intravitreal Injections |
1.4; 1.6; 0.7; 1.0 | 0.17 |
Summary
This study is designed to compare four currently used types of anesthesia used prior to intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections.
Eligibility Criteria
Inclusion Criteria
- Male or female > 40 years of age
- Diagnosis of age-related macular degeneration
- History of at least 1 intravitreal injection in the past in either eye
- Written informed consent has been obtained
Exclusion Criteria
- Known allergy or sensitivity to the study medications(s), it's components, or other agents required for the study procedures(e.g. Povidone iodine)
Data sourced from ClinicalTrials.gov (NCT00769392). 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.