Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections.

ABSTRACT:

Purpose

To test the safety and preliminary efficacy of rapid, nonpharmacologic anesthesia via cooling for intravitreal injections.

Design

Single-center, randomized phase 1 dose-ranging safety study (ClinicalTrials.gov identifier, NCT02872012).

Participants

Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included.

Methods

A handheld device was developed to provide anesthesia via cooling to a focal area on the surface of the eye before intravitreal treatment (IVT). In 22 patients undergoing bilateral IVT, 1 eye was randomized to receive standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia

SUBMITTER: Besirli CG 

PROVIDER: S-EPMC7541410 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature