Pain Clinical Trial
Official title:
Analgesic Effect Of Topical Nepafenac 0.1% On Pain Related To Intravitreal Injections: A Randomized Crossover Study
The analgesic effect of Nepafenac 0.1% Ophthalmic Drops on ocular pain related to
intravitreal injections will be evaluated.
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.
Ophthalmic nonsteroidal anti-inflammatory drugs (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% Eye Drops
a topical NSAID on pain related to intravitreal injections immediately after and up to six
hours post-IVI.
A number of patients scheduled to undergo IVIs will be divided in two 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 be randomized to receive Nepafenac 0.1% Eye Drops in
the first appointment and then crossover to receive the placebo (Artificial Tears) in their
next appointment for an IVI.
The patients of the second will be randomized to receive the placebo (Artificial Tears) in
the first appointment and then crossover to receive Nepafenac 0.1% Eye Drops in their next
appointment for an IVI.
All drugs will be administered prior to the injection by a member of the Department's
personnel (a staff nurse).
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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