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Handheld Vibrator Versus Topical Eye Drops as Anesthesia for Intravitreal Injections

NCT03079713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-05-09

No results posted yet for this study

Summary

Intravitreal injections are an efficient method of delivering therapeutic levels of medications to the posterior segment of the eye. Prior to receiving an injection, there are various methods to provide ocular anesthesia. Vibration may have an anti-nociceptive effect by directly decreasing the sensitivity of peripheral nociceptors or by reducing signal transmission from peripheral nociceptors to the brain with activation of vibratory sensation pathways. The purpose of this study is to evaluate the use of a handheld fingertip vibrator compared to topical eye drops for pain control while performing intravitreal eye injections. A secondary objective of the study is to measure corneal and conjunctiva sensitivity with and without activation of the vibrator to the lower lid using a Luneau Cochet-Bonnet aesthesiometer.

Conditions

  • Pain Control During Intravitreal Injections

Interventions

DEVICE

Handheld vibrator triggered during intravitreal injection for wet ARMD

A vibratory device cleaned with alcohol swabs between each use will be attached to the injectors' finger, placed on the lower eyelid of the treatment eye, and triggered during intravitreal injection

DEVICE

Normal eye esthesiometry with and without vibration

Healthy patients will undergo corneal and conjunctival esthesiometry with and without triggering of the wearable vibrator placed upon the lower lid of a single eye.

DEVICE

Handheld vibrator not triggered during intravitreal injection for wet ARMD

Control group undergoing standard intravitreal injection without triggering of the vibrator.

Sponsors & Collaborators

  • Mid Atlantic Retina

    collaborator OTHER

  • Wills Eye

    lead OTHER

Principal Investigators

  • Mitchell Fineman, MD · Mid Atlantic Retina

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2018-01-24
Completion
2019-03-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03079713 on ClinicalTrials.gov