Effect of Topical Nepafenac 0.1% on Pain Related to Intravitreal Injections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Analgesic Effect Of Topical Nepafenac 0.1% On Pain Related To Intravitreal Injections: A Randomized Crossover Study

Conditions
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Pain

Intervention / Treatment
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* Drug: Nepafenac Eye Drops
* Drug: Placebo (Artificial Tears)


Participation Criteria
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Eligibility Criteria
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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 bromfenac or other NSAIDs and salicylates, 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nepafenac 0.1% Eye Drops<br>One drop of Nepafenac 0.1% Eye Drops will be instilled to the eye's cul de sac prior to the intravitreal injection. | Drug: Nepafenac Eye Drops<br>* One drop instilled to the eye's cul de sac prior to the intravitreal injection.<br>* Other names: NEVANAC 0.1% Eye Drops;|
| Placebo Comparator: Artificial Tears<br>One drop of Artificial Tears will be instilled to the eye's cul de sac prior to the intravitreal injection. | Drug: Placebo (Artificial Tears)<br>* One drop instilled to the eye's cul de sac prior to the intravitreal injection<br>* Other names: TEARS NATURALE 0.1%+0.3% Eye Drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Nepafenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale. |  | Immediately and 6 hours after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Nepafenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the main component of the short form of the McGill Pain Questionnaire |  | Immediately and 6 hours after injection | 
| Assessment of Nepafenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the main component of the Present Pain Intensity score |  | Immediately and 6 hours after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravitreal injection, pain, non-steroidal anti-inflammatory drugs, anti-VEGF, nepafenac