Comparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections, a Triple Arm Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs
研究概览
简要总结
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.
详细描述
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.
Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit the activity of cyclooxygenase-1 and cyclooxygenase-2, and thereby, the synthesis of prostaglandins and thromboxanes. Cyclooxygenase-2 inhibition leads to the anti-inflammatory, analgesic and antipyretic effects of NSAIDs. Ophthalmic 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% and Nepafenac 0.3% Eye Drops on pain related to intravitreal injections immediately after and up to six hours postIVI.
A number of patients scheduled to undergo IVIs of anti-VEGFs will be randomized and divided in three 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 receive Nepafenac 0.1 % Eye Drops 45 minutes prior to the injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Nepafenac 0.1% Oph Susp
One drop of Nepafenac 0.1% will be administered 45' prior to the injection
干预措施: Nepafenac 0.1% Oph Susp (Drug)
Nepafenac 0.3% Oph Susp
One drop of Nepafenac 0.3% will be administered 45' prior to the injection
干预措施: Nepafenac 0.3% Oph Susp (Drug)
Artificial tears
One drop of Artificial Tears will be administered 45' prior to the injection
干预措施: Artificial tear (Drug)
结局指标
主要结局
Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs
时间窗: Immediately after the injection
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.
次要结局
- Assessment of topical Nepafenac 0.1% and Nepafenac 0.3% analgesic effect in patients undergoing intravitreal injections of anti-VEGFs(Six hours after injection)
研究者
Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
University Hospital of Patras