Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
Recruitment status was Active, not recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection|
- Discomfort from anesthesia for intravitreal injection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- To examine the side effects and discomfort associated with the intravitreal injection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||October 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Drops of Proparacaine on the eye, administered as described in the package insert
Active Comparator: 2
Drops of Tetracaine on the eye, administered as described in the package insert
Active Comparator: 3
Lidocaine 4% soaked cotton sponge
A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva
Active Comparator: 4
Lidocaine 2% subconjunctival injection
A subconjunctival injection of Lidocaine 2%
Over the last several years intravitreal injection of pharmacologic agents has become a common procedure in ophthalmology. Injected agents include steroid, antibiotics, and most recently anti-VEGF agents. There are many methods of preparing a patient for intravitreal injection. While there are guidelines for infection prophylaxis, there is currently no standard of care or consensus on which method of anesthesia is most effective in reducing pain and discomfort associated with intravitreal injections.
Patients who have received prior injections and are scheduled to continue regular injections will be randomized to one of four types of anesthetic treatment for each of 4 treatment periods, so that each subject receives all four types of anesthesia over the course of the study, although the order will be different for each subject.
Following each procedure, patients will fill out a questionnaire, grading the discomfort of both the anesthesia and the injection(on separate 0-10 scales).
The anesthetic methods used will include: 1.) Drops of Proparacaine on the eye, 2.) Drops of Tetracaine on the eye, 3.) A cotton sponge (pledget) soaked with Lidocaine 4% placed over the conjunctiva and 4.)A subconjunctival injection with 2% Lidocaine.
The subjects' number and type of visits, tests and treatments will be standard of care and will not be different due to the study. The total time for the treatment part of the study is the four injections or approximately 4 months and will be followed for up to 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769392
|United States, Massachusetts|
|Lahey Clinic Arlington|
|Arlington, Massachusetts, United States, 02474|
|Lahey Clinic, Inc.|
|Burlington, Massachusetts, United States, 01805|
|Lahey Clinic Northshore|
|Peabody, Massachusetts, United States, 01960|
|Principal Investigator:||Gregory R. Blaha, M.D., Ph.D.||Lahey Clinic, Inc.|