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

Lahey Clinic28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Macular Degeneration

Interventions

Proparacaine OphthalmicDRUG

Drops of Proparacaine on the eye, administered as described in the package insert

Tetracaine OphthalmicDRUG

Drops of Tetracaine on the eye, administered as described in the package insert

Lidocaine 4%DRUG

A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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)

Locations (3)

Lahey Clinic Arlington

Arlington, Massachusetts, United States

Lahey Clinic, Inc.

Burlington, Massachusetts, United States

Lahey Clinic Northshore

Peabody, Massachusetts, United States

Outcomes

Primary Outcomes

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)

Time frame: 16 weeks

Secondary Outcomes

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).

Time frame: 16 weeks

Data from ClinicalTrials.gov

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