Pain Control During Intravitreal InjectionsEyebratorNCT03079713
Handheld Vibrator Versus Topical Eye Drops as Anesthesia for Intravitreal Injections
A study testing Handheld vibrator triggered during intravitreal injection for wet ARMD, Normal eye esthesiometry with and without vibration and Handheld vibrator not triggered during intravitreal injection for wet ARMD in people with Pain Control During Intravitreal Injections, run by Wills Eye at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Control During Intravitreal Injections
- What is being tested?
- Handheld vibrator triggered during intravitreal injection for wet ARMD, Normal eye esthesiometry with and without vibration and Handheld vibrator not triggered during intravitreal injection for wet ARMD
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2017to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of neovascular age related macular degeneration requiring anti-VEGF intravitreal injection in the routine course of their care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
MidAtlantic Retina-Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparison of Handheld Vibrator to Topical Eye Drops as Anesthesia for Intravitreal Injections
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.
Read the 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.
- Being tested
- Handheld vibrator triggered during intravitreal injection for wet ARMD, Normal eye esthesiometry with and without vibration, Handheld vibrator not triggered during intravitreal injection for wet ARMD
- Keywords
- pain, anesthesia, vibrator, intravitreal, injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Vibratory Anesthesia | Experimental | Following administration of topical anesthetic and betadine, wearable vibrator will be triggered prior to and during the intravitreal injection Receives: 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 Receives: 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. Receives: Device: Normal eye esthesiometry with and without vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Pain is assessed by Wong-Baker FACES Pain Rating Scale (score ranging from 0 to 10) immediately after the intravitreal injection
Measured: Immediately after intravitreal injection
Secondary outcomes (1)
Corneal and conjunctival sensitivity
Corneal and conjunctival sensitivity, as measured using an aesthesiometer
Measured: immediately after application of a handheld vibrator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start12 Apr 2017
- Primary completion24 Jan 2018
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain Control During Intravitreal InjectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Mid Atlantic Retina
- Responsible party
- Principal investigator, MidAtlantic Retina, Wills Eye
- Investigators
- Mitchell Fineman, MD, Principal investigator, Mid Atlantic Retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079713
- Sponsor's protocol ID
- 16-600E
- Acronym
- Eyebrator
- Status last verified
- May 2019
- First submitted
- 8 Mar 2017
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17056383Kaderli 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.
PubMed 17061223Cintra 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.
PubMed 19205490Karabas 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.
PubMed 25949822Ornek 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.
PubMed 24843332Lundeberg TC. Vibratory stimulation for the alleviation of chronic pain. Acta Physiol Scand Suppl. 1983;523:1-51.
PubMed 6609524Smith 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.
PubMed 15530291Aminabadi 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.
PubMed 18784857Bagherian 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.
PubMed 27274349Nanitsos 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.
PubMed 19473149
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Handheld Vibrator to Topical Eye Drops as Anesthesia for Intravitreal Injections
- ClinicalTrials.gov ID
- NCT03079713
- Acronym / sponsor ID
- Eyebrator / 16-600E
- Keywords
- pain, anesthesia, vibrator, intravitreal, injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Mid Atlantic Retina
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vibratory Anesthesia | Experimental | Device: Handheld vibrator triggered during intravitreal injection for wet ARMDFollowing administration of topical anesthetic and betadine, wearable vibrator will be triggered prior to and during the intravitreal injection |
| Standard Injection. | Sham comparator | Device: Handheld vibrator not triggered during intravitreal injection for wet ARMDFollowing 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 |
| Vibratory Anesthesia with Corneal/Conjunctival Sensation Test | Experimental | Device: Normal eye esthesiometry with and without vibrationHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of neovascular age related macular degeneration requiring anti-VEGF intravitreal injection in the routine course of their care
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handheld vibrator triggered during intravitreal injection for wet ARMDA 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 | Vibratory Anesthesia |
| Normal eye esthesiometry with and without vibrationHealthy 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 | Vibratory Anesthesia with Corneal/Conjunctival Sensation Test |
| Handheld vibrator not triggered during intravitreal injection for wet ARMDControl group undergoing standard intravitreal injection without triggering of the vibrator. | Device | Standard Injection. |
Primary outcome
Pain assessment
Time frame: Immediately after intravitreal injection
Pain is assessed by Wong-Baker FACES Pain Rating Scale (score ranging from 0 to 10) immediately after the intravitreal injection
1 secondary outcome
Corneal and conjunctival sensitivity
Time frame: immediately after application of a handheld vibrator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Background: PubMed 17056383Friedman 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.
- Background: PubMed 17061223Kaderli 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.
- Background: PubMed 19205490Cintra 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.
- Background: PubMed 25949822Karabas 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.
- Background: PubMed 24843332Ornek 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.
- Background: PubMed 6609524Lundeberg TC. Vibratory stimulation for the alleviation of chronic pain. Acta Physiol Scand Suppl. 1983;523:1-51.
- Background: PubMed 15530291Smith 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.
- Background: PubMed 18784857Aminabadi 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.
- Background: PubMed 27274349Bagherian 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.
- Background: PubMed 19473149Nanitsos 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Fineman, MD principal investigator
Mid Atlantic Retina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld vibrator triggered during intravitreal injection for wet ARMD, Normal eye esthesiometry with and without vibration and Handheld vibrator not triggered during intravitreal injection for wet ARMD in people with Pain Control During Intravitreal Injections, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: Immediately after intravitreal injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079713, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.