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van CCT (UK)

van CCT (UK)

Pain from intraocular injections with ultrathin needles compared to regular needles.

- candidate number14155
- NTR NumberNTR3770
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jan-2013
- Secondary IDs2012/259 METC
- Public TitlePain from intraocular injections with ultrathin needles compared to regular needles.
- Scientific TitlePain experienced from intravitreal injection with a 33 gauge needle vs a 30 gauge needle: is thinner better?
- hypothesisIntravitreal injections are used more and more frequently in ophthalmology. This trend is mostly caused by the arrival of anti-VEGF agents used for age-related macular degeneration, diabetic macular edema and macular edema secondary to retinal vein occlusion. It is known from clinical practice that discomfort and pain at the injection site are common side effects from intravitreal injections. In current practice 30 gauge needles are often used for intravitreal injections with bevacizumab and they have been shown to cause less pain and vitreal reflux than thicker needles. We expect pain level can be lowered even further by reducing needle width to 33 gauge.
- Healt Condition(s) or Problem(s) studiedPain, Injection, Intraocular, Intravitreal
- Inclusion criteriaPatients with an indication for at least two consecutive monthly intravitreal injections with bevacizumab.
- Exclusion criteriaPatients unable to state pain levels or give written informed consent.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-jan-2013
- planned closingdate21-feb-2013
- Target number of participants75
- InterventionsTwo consecutive intraocular bevacizumab injections with a 33G and 30G needle.
- Primary outcomePain score on 100mm numeric rating scale.
- Secondary outcomePatientsí stress levels and expectation questionnaire scores.
- TimepointsInjection nr 1 at timepoint 0 and injection nr 2 after 1 month.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Center Nijmegen
- PublicationsN/A
- Brief summaryRationale:
Pain and discomfort at the injection site are common side effects of intravitreal injections with bevacizumab. In current practice 30 gauge needles are regularly used for these intravitreal injections and they have been shown to cause less pain than thicker needles.

The main objective of this study is to evaluate whether pain caused by intravitreal bevacizumab injections with the regular 30 gauge needle can be reduced by using a 33 gauge needle.

Study design:
Double-blind, randomized, cross-over trial.

Study population:
Patients eligible for treatment with two consecutive injections with intravitreal bevacizumab.

All patients receive two consecutive intravitreal injections with bevacizumab 1.25 mg in 0.05 ml as decided by their treating physician. Patients are randomized to receive the first intravitreal injection either with the regular 30 gauge or the 33 gauge needle. The interval for the second injection will be 2-6 weeks and will be performed using the alternate injection needle.

Study endpoints:
The primary outcome is the degree of pain during the intravitreal injection, as measured on a 100 mm numeric rating scale (NRS) of pain intensity. The secondary endpoint is anxiety experienced during the injection procedure determined using the hospital anxiety depression scale (HADS) and the state-trait anxiety inventory (STA-I).

Burden and risks associated with participation:
Patients are asked to fill in a HADS and STA-I questionnaire prior to the two consecutive injections and to score the degree of pain experienced during the intravitreal injections on a 100 mm NRS immediately after the procedure. There are no known risks associated with a higher needle gauge. Patients will be informed of the risks related to the injection procedure itself, namely endophthalmitis, retinal detachment and increased risk of cataract, which are the same as in normal clinical practice and are unlikely to be associated with needle gauge.
- Main changes (audit trail)
- RECORD4-jan-2013 - 16-jan-2013

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