CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Handheld vibrator triggered during intravitreal injection for wet ARMD +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03079713
NCT03079713N/ACompleted

Comparison of Handheld Vibrator to Topical Eye Drops as Anesthesia for Intravitreal Injections

Wills Eye·interventional·Posted Mar 14, 2017·Updated May 9, 2019

In Brief

A clinical study evaluating Handheld vibrator triggered during intravitreal injection for wet ARMD, Normal eye esthesiometry with and without vibration, and 1 other intervention for Pain Control During Intravitreal Injections. Completed, enrolled 110 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMid Atlantic Retina

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 14, 2017
Enrollment StartApr 12, 2017
Primary CompletionJan 24, 2018
Study CompletionMar 20, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.3 years ago

Interventions

Handheld vibrator triggered during intravitreal injection for wet ARMDdevice

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

Normal eye esthesiometry with and without vibrationdevice

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.

Handheld vibrator not triggered during intravitreal injection for wet ARMDdevice

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