EUCTR2016-003232-21-AT进行中（未招募）1 期
EffiCacy and safety of topical ketoroLac trOmethamine and sUbtenon triamcinolone acetonideand a watch-and-wait” strategy for acute pseudophakic macular eDema: a randomized phase-3 trial - CLOUD
Medizinische Universität Graz, Univers. Augenklinik0 个研究点目标入组 249 人开始时间: 2017年10月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 249
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- =18 years of age
- •-Pseudophakia in the study eye
- •-No history of previous treatment of PME
- •-Signed written informed consent
- •-Cataract surgery =4 months in study eye
- •-BCVA =20/125; BVCA =20/32
- •-Presence of PME determined by fundus examination
- •-Presence of central macular edema determined by OCT
- •-No sign of significant diabetic retinopathy and/or maculopathy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 224
排除标准
- •-Pregnancy /Breast-feeding
- •-Systemic treatment with corticosteroids in the preceding 14 days
- •-Systemic treatment with NSAIDs in the preceding 14 days
- •-Presence of any contradictions indicated in the summary of product characteristics for the use of topical ketorolac tromethamine 0.5% and subtenon triamcinolone acetonide injection
- •-Active choroidal neovascularization
- •-Retinal detachment
- •-Vitreoretinal surgery in the preceding year
- •-Myopia =8 diopters
- •-Uncontrolled glaucoma
研究者
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