Pain Clinical Trial
Official title:
Comparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections, a Triple Arm Study
Verified date | April 2018 |
Source | University Hospital of Patras |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 the McGill Pain Questionnaire.
Status | Completed |
Enrollment | 99 |
Est. completion date | March 28, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 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 |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Patras | Patra | Achaia |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Patras |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs | As measured by the Visual Analogue Scale. The Visual Analogue Scale (abbreviation VAS) is a self report pain score chart designed as a 10 cm horizontal line marked at both ends. Each boundary of the line represents the extremes of painful experience (0=no pain and 10= the worst pain ever experienced). The patient is asked to mark on the scale the exact point corresponding to their perception of pain intensity and the score is calculated by measuring from the left hand side to the mark made by the patient, ranging from 0 to 10. Higher scores indicate more severe pain. |
Immediately after the injection | |
Secondary | Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs | As measured by the Visual Analogue Scale. The Visual Analogue Scale (abbreviation VAS) is a self report pain score chart designed as a 10 cm horizontal line marked at both ends. Each boundary of the line represents the extremes of painful experience (0=no pain and 10= the worst pain ever experienced). The patient is asked to mark on the scale the exact point corresponding to their perception of pain intensity and the score is calculated by measuring from the left hand side to the mark made by the patient,ranging from 0 to 10. Higher scores indicate more severe pain. |
Six hours after injection | |
Secondary | Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs | As measured by the Main Component of the Short Form of the McGill Pain Questionnaire. The main component of the Short form of the McGill Pain Questionnaire (abbreviation SF-MPQ) comprises of 15 adjectives describing the pain experienced (11 sensory and 4 affective). The patient is asked to grade the intensity of each specific pain quality on an intensity scale from 0 to 3 (0= none, 1=mild, 2=moderate, 3=severe). The total score of the main component is derived by adding the rank values given by the patient for each descriptor out of 45. Scores can range from 0 to 45. A higher score of the main component of the SF-MPQ reflects more serious pain. |
Immediately after the injection | |
Secondary | Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs | As measured by the Main Component of the Short Form of the McGill Pain Questionnaire. The main component of the Short form of the McGill Pain Questionnaire (abbreviation SF-MPQ) comprises of 15 adjectives describing the pain experienced (11 sensory and 4 affective). The patient is asked to grade the intensity of each specific pain quality on an intensity scale from 0 to 3 (0= none, 1=mild, 2=moderate, 3=severe). The total score of the main component is derived by adding the rank values given by the patient for each descriptor out of 45. Scores can range from 0 to 45. A higher score of the main component of the SF-MPQ reflects more serious pain. |
Six hours after injection | |
Secondary | Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs | As measured by the Present Pain Intensity score. The PPI index is a numerical verbal rating scale consisting of 6 adjectives of gradually increasing pain sensation (0, none; 1, mild; 2, discomforting; 3, distressing; 4, horrible; and 5, excruciating). The patient is instructed to choose the adjective indicating their pain state. The score for the PPI is derived from the number next to the patients' adjective of choice, ranging from 0 to 5. Higher scores indicate more intense pain. |
Immediately after the injection | |
Secondary | Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs | As measured by the Present Pain Intensity score. The Present Pain Intensity (abbreviation PPI) index is a numerical verbal rating scale consisting of 6 adjectives of gradually increasing pain sensation (0, none; 1, mild; 2, discomforting; 3, distressing; 4, horrible; and 5, excruciating). The patient is instructed to choose the adjective indicating their pain state. The score for the PPI is derived from the number next to the patients' adjective of choice, ranging from 0 to 5. Higher scores indicate more intense pain. |
Six hours after injection |
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