EUCTR2012-004873-14-HU进行中（未招募）不适用
PREvention of Macular EDema after cataract surgery - PREMED
niversity Eye Clinic Maastricht0 个研究点目标入组 1,350 人开始时间: 2013年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,350
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 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •-Age below 21 years old;
- •-Functional monoculus;
- •-Previous ocular surgery;
- •-Diabetes with 1) macular edema with a CSMT of 450 µm or more; 2) very severe nonproliferative or proliferative diabetic retinopathy needing panretinal photocoagulation or vitrectomy; or 3) vitreaous haemorrhage present at initiation visit
- •- non-diabetic patients with cystoid macular edema
- •-History of glaucoma, use of anti-glaucomatous medication or steroid-induced IOP elevation that required IOP-lowering treatment;
- •-IOP = 25 mmHg;
- •-Post-traumatic cataract;
- •-History of any ocular inflammation or uveitis;
- •-History of pseudoexfoliation syndrome, which is expected to cause peroperative complications ;
- •-History of Fuchs' endothelial dystrophy or cornea guttata 3+;
- •-History of retinal vein occlusion;
- •- Any macular pathology that might influence VA, other than diabetic macular edema;
- •-Cerebrovascular accident, myocardial infarction or other thromboembolic events in the previous 3 months;
- •-History of recurrent thromboembolic events;
- •-History of severe systemic bleeding in the previous 3 months;
- •-Major surgery in the previous 3 months;
- •-Intravitreal bevacizumab or ranibizumab within in the previous 6 weeks or intravitreal aflibercept within the previous 10 weeks before study initiation;
- •-Intra- or periocular corticosteroid injection in the previous 4 months;
- •-Current use of topical NSAIDs or corticosteroids;
- •-Use of systemic corticosteroids (=20mg prednisolone or equivalence);
- •-History of relevant (serious) adverse events occurring after administration of NSAID’s, acetylsalicylic acid, sodium sulphite, corticosteroids or bevacizumab;
- •-Contraindications for use of topical NSAIDs, topical or subconjunctival corticosteroids or intravitreal bevacizumab (e.g. tuberculosis, pregnancy, nursing mothers);
- •-Combined surgery (e.g. combined phacoemulsification and trabeculectomy or phacoemulsification and descemet stripping automated endothelial keratoplasty )
研究者
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