Status:

COMPLETED

Comparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections

Lead Sponsor:

University Hospital of Patras

Conditions:

Pain

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 th...

Detailed Description

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 var...

Eligibility Criteria

Inclusion

  • 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

  • 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 nepafenac 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

Key Trial Info

Start Date :

September 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 28 2018

Estimated Enrollment :

99 Patients enrolled

Trial Details

Trial ID

NCT03406689

Start Date

September 1 2017

End Date

March 28 2018

Last Update

April 4 2018

Active Locations (1)

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1

University Hospital of Patras

Pátrai, Achaia, Greece, 26504