Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

Study Overview
=================
Brief 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.

Detailed 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 utilize 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. The order of the anesthetic treatment the subject will receive prior to each planned intravitreal injection during the study period will be different for each subject. This will decrease the effect of extraneous variables from influencing subjective pain scores. Following each procedure, patients will fill out an analog pain scale questionnaire, grading the discomfort of receiving 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 coincides with four injections (1 injection per month) or approximately 4 months and will be followed for up to 6 months.

Official Title
-----------------
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Proparacaine Ophthalmic
* Drug: Tetracaine Ophthalmic
* Drug: Lidocaine 4%
* Drug: Lidocaine 2% Injectable Solution


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All Participants<br>All Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparacaine Ophthalmic drops used prior to Injection 1; Tetracaine Ophthalmic drops used prior to Injection 2; Lidocaine 4% sponge used prior to Injection 3; Lidocaine 2% injectable solution (subconjunctival) used prior to Injection 4). | Drug: Proparacaine Ophthalmic<br>* Drops of Proparacaine on the eye, administered as described in the package insert<br>Drug: Tetracaine Ophthalmic<br>* Drops of Tetracaine on the eye, administered as described in the package insert<br>Drug: Lidocaine 4%<br>* A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva<br>Drug: Lidocaine 2% Injectable Solution<br>* A subconjunctival injection of Lidocaine 2%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort Associated With the Intravitreal Injection | Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort From Anesthesia Used Prior to Intravitreal Injections | Discomfort from Anesthesia used prior to Intravitreal Injections using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10). | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular Degeneration, Intravitreal injections, Eye anesthesia-Topical/subconjunctival, Eye-surgical procedures, Ophthalmologic anesthesia methods