EUCTR2012-004873-14-BE进行中（未招募）1 期
PREvention of Macular EDema after cataract surgery - PREMED
niversity Eye Clinic Maastricht UMC0 个研究点目标入组 1,008 人开始时间: 2015年4月30日最近更新:
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
- 1,008
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
- 性别
- All
入选标准
- •All patients undergoing routine phacoemulsification.
- •Only one eye per patient will be included in the study.
- •Patients should be able to communicate properly and understand instructions.
- •All patients must accept possible off-label use of study medication before inclusion in this study.
- •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 208
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 800
排除标准
- •Study procedures will be different for diabetic and non-diabetic patients. Therefore, the exclusion criteria will also be different for diabetic and non-diabetic patients.
- •General exclusion criteria for participation in this study are:
- •1.age below 21 years old;
- •2.participation in another clinical study;
- •3.post-traumatic cataract;
- •4.combined surgery;
- •5.functional monoculus;
- •6.previous ocular surgery;
- •7.progressive glaucoma with severe visual field defects, use of anti-glaucomatous medication or steroid-induced IOP elevation that required IOP-lowering treatment;
- •8.IOP = 25 mmHg;
- •9.history of intraocular inflammation or uveitis;
- •10.history of pseudoexfoliation syndrome, which is expected to cause peroperative complications;
- •11.history of Fuchs' endothelial dystrophy or cornea guttata 3+;
- •12.history of retinal vein occlusion;
- •13.any macular pathology that might influence VA, other than DME
- •14.use of intravitreal bevacizumab or ranibizumab in the previous 6 weeks or intravitreal aflibercept in the previous 10 weeks;
- •15.use of intra- or periocular corticosteroid injection in the previous 4 months;
- •16.current use of topical NSAIDs or corticosteroids;
- •17.use of systemic corticosteroids (= 20 mg prednisolone or equivalence);
- •18.history of relevant adverse events, including serious adverse events (SAE), occurring after administration of NSAIDs, acetylsalicylic acid, sodium sulphite, corticosteroids or bevacizumab;
- •19.contraindications for use of topical NSAIDs, topical or subconjunctival corticosteroids or intravitreal bevacizumab or related drugs
- •Non-diabetic patients with a history of CME will be excluded from participation in the study.
- •Additionally, diabetic patients will be excluded from participation in case of:
- •1.macular edema with a CSMT =450 µm;
- •2.very severe NPDR or proliferative DR requiring panretinal photocoagulation or vitrectomy;
- •3.vitreous haemorrhage present during preoperative visit(s);
- •4.cerebrovascular accident (CVA), myocardial infarction (MI) or other thromboembolic events in the previous 3 months;
- •5.a history of recurrent thromboembolic events;
- •6.a history of severe systemic bleeding in the previous 3 months;
- •7.major surgery in the previous 3 months;
- •8.history of glaucoma;
研究者
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