Handheld Vibrator Versus Topical Eye Drops as Anesthesia for Intravitreal Injections

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain Control During Intravitreal Injections

Intervention / Treatment
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* Device: Handheld vibrator triggered during intravitreal injection for wet ARMD
* Device: Normal eye esthesiometry with and without vibration
* Device: Handheld vibrator not triggered during intravitreal injection for wet ARMD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibratory Anesthesia<br>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<br>* 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<br>|
| Sham Comparator: Standard Injection.<br>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<br>* Control group undergoing standard intravitreal injection without triggering of the vibrator.<br>|
| Experimental: Vibratory Anesthesia with Corneal/Conjunctival Sensation Test<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal and conjunctival sensitivity | Corneal and conjunctival sensitivity, as measured using an aesthesiometer | immediately after application of a handheld vibrator | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, anesthesia, vibrator, intravitreal, injection