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

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.

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)