Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02837770
• Date of registration: 13/07/2016
• Prospective Registration: No
• Primary sponsor: University Hospital of Patras
• Public title: Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections
• Scientific title: Analgesic Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections, a Randomized, Triple-arm, Double-blind, Placebo-controlled Study.
• Date of first enrolment: July 2016
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02837770
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Greece

Contacts

• Name: Constantine Georgakopoulos, MD, Phd
• Affiliation: Associate Professor of Ophthalmology, Medical School, University of Patras, Greece

Key inclusion & exclusion criteria

Inclusion Criteria:

- All participants will be patients of the Medical Retina Department of our Clinic, who
are scheduled to receive IVIs of ranibizumab (Lucentis; Novartis Pharma S.A.S.,
Huningue, France) or aflibercept (Eylea; Bayer Healthcare Pharmaceuticals, Berlin,
Germany) in one eye and had already undergone at least one IVI of an anti-VEGF agent.

Exclusion Criteria:

- History of previous eye surgery other than cataract extraction surgery, herpetic eye
disease, uncontrolled glaucoma, uveitis, active conjunctivitis, keratitis and bullous
keratopathy, a previously known allergic response to diclofenac or other NSAIDs and
salicylates, any contraindication to NSAIDs administration such as cardiovascular
disease, gastrointenstinal disease with risk of GI ulceration,bleeding and
perforation, renal and hepatic disease and any systemic or topical use of NSAIDs or
any use of sedative medications within 7 days from the visit and during the day of
IVI.

- Patients with poor cooperation in understanding and answering the questions of the
SF-MPQ, including the visual analogue scale (VAS).

- Unsuccessful blinding



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: Diclofenac Eye Drops

Drug: Pacebo pill

Drug: Artificial Tears

Drug: Oral Diclofenac

Primary Outcome(s)

Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale. [Time Frame: Immediately after injection]

Secondary Outcome(s)

Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score [Time Frame: Immediately after injection]

Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale. [Time Frame: Six hours after injection]

Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score [Time Frame: Six hours after injection]

Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Main Component of the Short Form of the McGill Pain Questionnaire [Time Frame: Six hours after injection]

Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Main Component of the Short Form of the McGill Pain Questionnaire [Time Frame: Immediately after injection]

Secondary ID(s)

72/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors