Handheld Vibrator Versus Topical Eye Drops as Anesthesia for Intravitreal Injections

NCT03079713 | Completed DMC

• 1 other identifier: 16-600E
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pain; anesthesia; vibrator; intravitreal; injection

Outcome Measures

Primary Outcomes (1)

• Pain assessment

  Pain is assessed by Wong-Baker FACES Pain Rating Scale (score ranging from 0 to 10) immediately after the intravitreal injection

  Immediately after intravitreal injection

Secondary Outcomes (1)

• Corneal and conjunctival sensitivity

  immediately after application of a handheld vibrator

Study Arms (3)

Vibratory Anesthesia

EXPERIMENTAL

Following administration of topical anesthetic and betadine, wearable vibrator will be triggered prior to and during the intravitreal injection

Device: Handheld vibrator triggered during intravitreal injection for wet ARMD

Standard Injection.

SHAM COMPARATOR

Following administration of topical anesthetic and betadine, wearable vibrator will be placed against the lower lid but NOT triggered prior to and during the intravitreal injection

Device: Handheld vibrator not triggered during intravitreal injection for wet ARMD

Vibratory Anesthesia with Corneal/Conjunctival Sensation Test

EXPERIMENTAL

Healthy patients not requiring intravitreal injection will be subjected to corneal and conjunctival aesthesiometry with and without the vibrator triggered while in contact with the lower eyelid of a single eye.

Device: Normal eye esthesiometry with and without vibration

Interventions

Handheld vibrator triggered during intravitreal injection for wet ARMD DEVICE

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

Vibratory Anesthesia

Normal eye esthesiometry with and without vibration DEVICE

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.

Vibratory Anesthesia with Corneal/Conjunctival Sensation Test

Handheld vibrator not triggered during intravitreal injection for wet ARMD DEVICE

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

Standard Injection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of neovascular age related macular degeneration requiring anti-VEGF intravitreal injection in the routine course of their care

You may not qualify if:

• History of endophthalmitis, prior ocular surgery except cataract surgery, globe rupture, retinal detachment, neurotrophic keratopathy, a history of corneal epithelial basement membrane dystrophy, recent corneal abrasion or trauma, history of infectious keratitis, lower eyelid pathology, those with a previously documented hypersensitivity to ophthalmic 5% povidone-iodine solution (Betadine; Alcon Labs, Fort Worth, TX) or inability to grade pain using the pain scale, pregnant patients, institutionalized patients (nursing home residents, prisoners), those with a history of diabetes

Sponsors & Collaborators

• Wills Eye: lead
• Mid Atlantic Retina: collaborator

Study Sites (1)

MidAtlantic Retina-Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (10)

• Friedman SM, Margo CE. Topical gel vs subconjunctival lidocaine for intravitreous injection: a randomized clinical trial. Am J Ophthalmol. 2006 Nov;142(5):887-8. doi: 10.1016/j.ajo.2006.06.033.

  PMID: 17056383 BACKGROUND

• Kaderli B, Avci R. Comparison of topical and subconjunctival anesthesia in intravitreal injection administrations. Eur J Ophthalmol. 2006 Sep-Oct;16(5):718-21. doi: 10.1177/112067210601600509.

  PMID: 17061223 BACKGROUND

• Cintra LP, Lucena LR, Da Silva JA, Costa RA, Scott IU, Jorge R. Comparative study of analgesic effectiveness using three different anesthetic techniques for intravitreal injection of bevacizumab. Ophthalmic Surg Lasers Imaging. 2009 Jan-Feb;40(1):13-8. doi: 10.3928/15428877-20090101-05.

  PMID: 19205490 BACKGROUND

• Karabas VL, Ozkan B, Kocer CA, Altintas O, Pirhan D, Yuksel N. Comparison of two anesthetic methods for intravitreal ozurdex injection. J Ophthalmol. 2015;2015:861535. doi: 10.1155/2015/861535. Epub 2015 Apr 9.

  PMID: 25949822 BACKGROUND

• Ornek N, Apan A, Ornek K, Gunay F. Anesthetic effectiveness of topical levobupivacaine 0.75% versus topical proparacaine 0.5% for intravitreal injections. Saudi J Anaesth. 2014 Apr;8(2):198-201. doi: 10.4103/1658-354X.130713.

  PMID: 24843332 BACKGROUND

• Lundeberg TC. Vibratory stimulation for the alleviation of chronic pain. Acta Physiol Scand Suppl. 1983;523:1-51.

  PMID: 6609524 BACKGROUND

• Smith KC, Comite SL, Balasubramanian S, Carver A, Liu JF. Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Dermatol Online J. 2004 Oct 15;10(2):1.

  PMID: 15530291 BACKGROUND

• Aminabadi NA, Farahani RM, Balayi Gajan E. The efficacy of distraction and counterstimulation in the reduction of pain reaction to intraoral injection by pediatric patients. J Contemp Dent Pract. 2008 Sep 1;9(6):33-40.

  PMID: 18784857 BACKGROUND

• Bagherian A, Sheikhfathollahi M. Children's behavioral pain reactions during local anesthetic injection using cotton-roll vibration method compared with routine topical anesthesia: A randomized controlled trial. Dent Res J (Isfahan). 2016 May-Jun;13(3):272-7. doi: 10.4103/1735-3327.182189.

  PMID: 27274349 BACKGROUND

• Nanitsos E, Vartuli R, Forte A, Dennison PJ, Peck CC. The effect of vibration on pain during local anaesthesia injections. Aust Dent J. 2009 Jun;54(2):94-100. doi: 10.1111/j.1834-7819.2009.01100.x.

  PMID: 19473149 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitchell Fineman, MD

  Mid Atlantic Retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mitchell Fineman MD

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 14, 2017
• Study Start: April 12, 2017
• Primary Completion: January 24, 2018
• Study Completion: March 20, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)