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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets on pain related to intravitreal injections will be evalutated.

Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital of Patras
• Treatments: Diclofenac; Lubricant Eye Drops; Ophthalmic Solutions; Tetrahydrozoline

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