Needle Size in Intravitreal Injections-Preliminary Results of a Randomized Clinical Trial | IOVS | ARVO... Page 1 of 2
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`FREE
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`ARVO Annual Meeting Abstract
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`| March 2012
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`Needle Size in Intravitreal Injections-
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`Preliminary Results of a Randomized
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`Clinical Trial
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`Christiane I. Falkner-Radler; Barbara Wimpissinger; Carl Glittenberg; Alexandra Graf; Susanne Binder
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`+ Author Affiliations & Notes
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`Investigative Ophthalmology & Visual Science March 2012, Vol.53, 884. doi:
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`Abstract
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`Purpose:
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`To evaluate the influence of the needle size used for intravitreal (IVT) injections on patients‘ pain
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`experience in a randomized, double-armed, single-blinded, single-centered clinical trial.
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`Methods:
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`Patients included were randomized to have an IVT injection performed with a 27-gauge needle
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`(group 1) or with a 30-gauge needle (group 2). The topical anesthesia before the injection was
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`standardized (0.5% tetracaine drops). Immediately after the injection, patients were asked to
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`grade their pain using the visual analogue scale (VAS) and the Wong-Baker FACES scale. The main
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`outcome measure was the pain score assessment. Co-factors analyzed were patients'
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`demographics (age and gender), clinical characteristics (right eye, left eye, number of previous
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`IVT injections) and the surgeon. In addition, scaled surgeon's questionnaires to asses the IVT
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`injection procedure were evaluated. For statistical analysis a regression model was used.
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`_Resu|ts:
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`LJp to now, the data of 126 patients (group1: 59 patients; group 2: 67 patients) were analyzed.
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`Mean VAS pain scores were 2.26 i 1.35 for group 1 and 2.27 i 1.66 for group 2. Mean Wong-
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`Baker pain scores were 1.95 i 1.51 for group 1 and 2.22 i 1.65 for group 2. There was no
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`significant difference in the VAS pain scores (p> 0.86) and in the Wong Baker pain scores (p>
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`0.36) between both treatment groups. Gender and the number of previous IVT injections
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`significantly influenced the VAS pain scores (p< 0.05), whereas age had a significant influence on
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`Needle Size in IntraVitreal Injections-Preliminary Results of a Randomized Clinical Trial | IOVS | ARVO... Page 2 of 2
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`the Wong Baker pain scores (p< 0.20). Female patients, patients with a history of previous IVT
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`injections and older patients had higher pain scores. The surgeon’s questionnaire showed an
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`overall preference towards the use of a 30-gauge needle for IVT injections.
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`_Conc|usions:
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`The use ofa 30-gauge needle for IVT injections showed no significant effect in pain relief
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`compared to the use ofa 27-gauge needle. However, a 30-gauge needle was preferred by all
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`surgeons.
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`_Clinical Trial:
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`_http://www.c|inicaltrials.gov NCT01477996
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`Keywords: retina - clinical (human) or epidemiologic studies: treatment/prevention
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`assessment/controlled clinical trials - injection
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`© 2012, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved.
`Permission to republish any abstract or part ofan abstract in any orm must be obtained in
`writing from the ARVO Office prior to publication.
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`https://iovs.arvoj ournalsorg/article.aspx?articleid=23 50271
`
`9/27/2018
`
`Regeneron Exhibit 1058.002
`
`