Overview

This trial is active, not recruiting.

Condition macular degeneration
Treatments proparacaine, tetracaine, lidocaine
Sponsor Lahey Clinic
Start date September 2008
End date October 2011
Trial size 100 participants
Trial identifier NCT00769392, 2008-076

Summary

This study is designed to compare four currently used types of anesthesia used for intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Proparacaine Drops
proparacaine
Drops of Proparacaine on the eye, administered as described in the package insert
(Active Comparator)
Tetracaine Drops
tetracaine
Drops of Tetracaine on the eye, administered as described in the package insert
(Active Comparator)
Lidocaine 4% soaked cotton sponge
lidocaine
A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva
(Active Comparator)
Lidocaine 2% subconjunctival injection
lidocaine
A subconjunctival injection of Lidocaine 2%

Primary Outcomes

Measure
Discomfort from anesthesia for intravitreal injection
time frame: 24 weeks

Secondary Outcomes

Measure
To examine the side effects and discomfort associated with the intravitreal injection
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 40 years old.

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)

Additional Information

Official title Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
Principal investigator Gregory R. Blaha, M.D., Ph.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Lahey Clinic.