Handheld Vibrator Versus Topical Eye Drops as Anesthesia for Intravitreal Injections

NCT ID: NCT03079713

Last Updated: 2019-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-12
• Study Completion Date: 2019-03-20

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.

Detailed Description

A total of 80 patients will be recruited for part 1 of the study. Participants will be randomized in a 1:1 ratio to a standard anesthetic group or standard anesthetic with vibration groups. All intravitreal drugs will be delivered via 30 gauge needles through the pars plana in the inferotemporal quadrant 3.5 to 4 mm posterior to the limbus. Once recruited, a single eye requiring injection for each enrolled patient will be randomized into 1 of 2 groups: aesthesiometer measurement alone with sham vibration (vibrator will not be triggered) (Group 1) or handheld vibrator application and triggering followed by aesthesiometer measurement (Group 2). The vibrator will be applied to the lower eyelid while retracting it during standard intravitreal injection prepped with topical anesthetic (Proparacaine 1%) and Betadine. The main outcome measure of will be patient comfort, as measured by the patient using a standardized Wong-Baker FACES Pain Rating Scale.

An additional 30 eyes of 30 healthy patients not requiring intravitreal injection will be recruited to determine the effect of vibrator application and triggering to the lower lid on corneal and conjunctival (inferotemporal quadrant) sensation as measured using an aesthesiometer. No topical anesthetic will be applied prior to esthesiometry measurements are taken with and without vibration triggering.

All patient identifying information will be removed and patients will be identified with a random number. Data will be checked regularly by a data monitoring committee. Patient records will be reviewed and the following data will be collected: demographic data (age, gender, injected eye, reason for injection), best-corrected visual acuity, intraocular pressure, and complications/adverse events associated with intravitreal injections. Statistical analyses will include univariate comparisons between treatment groups using the Student t-test for continuous variables and χ2 test or Fisher's exact test for categorical variables.

Conditions

Pain Control During Intravitreal Injections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Vibratory Anesthesia

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

Group Type: EXPERIMENTAL

Handheld vibrator triggered during intravitreal injection for wet ARMD

Intervention Type: 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

Standard Injection.

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

Group Type: SHAM_COMPARATOR

Handheld vibrator not triggered during intravitreal injection for wet ARMD

Intervention Type: DEVICE

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

Vibratory Anesthesia with Corneal/Conjunctival Sensation Test

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.

Group Type: EXPERIMENTAL

Normal eye esthesiometry with and without vibration

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Handheld vibrator not triggered during intravitreal injection for wet ARMD

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mid Atlantic Retina

OTHER

Sponsor Role: collaborator

Wills Eye

OTHER

Sponsor Role: lead

Responsible Party

MidAtlantic Retina

Dr Mitchell Fineman MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitchell Fineman, MD

Role: PRINCIPAL_INVESTIGATOR

Mid Atlantic Retina

Locations

MidAtlantic Retina-Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

16-600E

Identifier Type: -

Identifier Source: org_study_id