Analgesic Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections, a Randomized, Triple-arm, Double-blind, Placebo-controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.
研究概览
简要总结
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.
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 DIclofenac 0.1% Eye Drops a topical NSAID, as well as a combination of Diclofenac 0.1% Eye Drops and oral Diclofenac Sodium sustained-release (SR) 75mg tablets on pain related to intravitreal injections immediately after and up to six hours post-IVI.
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 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
研究组 & 干预措施
Pacebo pill and Diclofenac Eye Drops
Pacebo pill will be administered 4 hours before the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
干预措施: Diclofenac Eye Drops (Drug)
Pacebo pill and Diclofenac Eye Drops
Pacebo pill will be administered 4 hours before the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
干预措施: Pacebo pill (Drug)
Oral Diclofenac and Diclofenac Eye Drops
One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
干预措施: Oral Diclofenac (Drug)
Oral Diclofenac and Diclofenac Eye Drops
One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
干预措施: Diclofenac Eye Drops (Drug)
Pacebo pill and Artificial Tears
Pacebo pill will be administered 4 hours before the IVI and one drop Artificial Tears will be instilled 45' prior to the IVI.
干预措施: Pacebo pill (Drug)
Pacebo pill and Artificial Tears
Pacebo pill will be administered 4 hours before the IVI and one drop Artificial Tears will be instilled 45' prior to the IVI.
干预措施: Artificial Tears (Drug)
结局指标
主要结局
Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.
时间窗: Immediately after injection
次要结局
- Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Main Component of the Short Form of the McGill Pain Questionnaire(Six hours after injection)
- Assessment of topical and oral Diclofenac's analgesic effect in patients undergoing intravitreal injections of anti-VEGFs as measured by the Visual Analogue Scale.(Six hours after injection)
- Assessment of oral and topical Diclofenac's analgesic effect after intravitreal injections of anti-VEGFs as measured by the Present Pain Intensity score(Six hours after injection)
研究者
Constantinos D. Georgakopoulos, MD, PhD
Associate Professor of Ophthalmology
University Hospital of Patras