Pain Clinical Trial
Official title:
Comparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections, a Triple Arm Study
The analgestic efffect of Nepafenac 0.1% Eye Drops and Nepafenac 0.3% Eye Drops on pain
related to intravitreal injections will be evalutated.
Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.
Intravitreal injection (IVI) is a preferred route of administration of drugs in the posterior
segment of the eye. Intravitreal injection of anti-VEGFs constitutes the mainstay for the
treatment of various retinal diseases such as AMD, RVO, DME etc. The procedure of the IVI is,
however, associated with a level of discomfort for the patient.
Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit the activity of cyclooxygenase-1 and
cyclooxygenase-2, and thereby, the synthesis of prostaglandins and thromboxanes.
Cyclooxygenase-2 inhibition leads to the anti-inflammatory, analgesic and antipyretic effects
of NSAIDs. Ophthalmic NSAIDs constitute an established and effective treatment option for the
management of inflammation and pain associated with cataract surgery and of pain associated
with corneal refractive surgery, for inhibition of intraoperative miosis and for the
treatment of seasonal allergic conjunctivitis.
The primary goal of this study is to assess the analgesic effect of Nepafenac 0.1% and
Nepafenac 0.3% Eye Drops on pain related to intravitreal injections immediately after and up
to six hours postIVI.
A number of patients scheduled to undergo IVIs of anti-VEGFs will be randomized and divided
in three groups. All patients must have already undergone at least one IVI. In patients
receiving IVIs in both eyes only one eye will be included in the study.
The patients of the first group will receive Nepafenac 0.1 % Eye Drops 45 minutes prior to
the injection.
The patients of the second group will recieve Nepafenac 0.3 % Eye Drop 45 minutes prior to
the injection. The patients of the third group will receive Artificial Tears 45 minutes prior
to the injection.
Patients will be required to complete the greek version of the short form McGill Pain
Questionnaire (SF-MPQ) comprising of the Visual Analogue Scale, the main component of the
SF-MPQ and the Present Pain Intensity Scale immediately after the injection and 6 hours
post-IVI.
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