EUCTR2012-004873-14-PT进行中（未招募）1 期
PREvention of Macular EDema after cataract surgery - PREMED
niversity Eye Clinic Maastricht0 个研究点目标入组 1,008 人开始时间: 2014年3月14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
- 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 202
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 806
排除标准
- •General exclusion criteria for participation in this study are:
- •- age below 21 years old;
- •- patients already participating in another clinical study;
- •- post-traumatic cataract
- •- combined surgery (e.g. combined phacoemulsification and trabeculectomy or phacoemulsification and DSAEK);
- •- functional monoculus;
- •- previous ocular surgery;
- •- progressive glaucoma with severe visual field defects, use of anti-glaucomatous medication or steroid-induced IOP elevation that required IOP-lowering treatment;
- •- IOP = 25 mmHg;
- •- history of intra ocular inflammation or uveitis;
- •- history of pseudoexfoliation syndrome, which is expected to cause peroperative complications (e.g. transillumination defects at the pupillary margin or zonulolysis);
- •- history of Fuchs' endothelial dystrophy or cornea guttata 3+;
- •- history of retinal vein occlusion;
- •- any macular pathology that might influence VA, other than DME (e.g. macular pucker, macular hole, severe age-related macular degeneration (AMD))
- •- use of intravitreal bevacizumab or ranibizumab in the previous 6 weeks or intravitreal aflibercept in the previous 10 weeks;
- •- use of intra- or periocular corticosteroids injection in the previous 4 months;
- •- current use of topical NSAIDs or corticosteroids;
- •- use of systemic corticosteroids (= 20mg prednisolone or equivalence);
- •- history of relevant adverse events, including serious adverse events (SAE) occurring after administration of NSAIDs, acetylsalicylic acid, sodium sulphite, corticosteroids or bevacizumab;
- •- contraindications for use of topical NSAIDs, topical or subconjunctival corticosteroids or intravitreal bevacizumab or related drugs (e.g. tuberculosis, pregnancy, planning to become pregnant in the coming 6 months, nursing mothers);
- •Exclusion criteria for non-diabetic patients
- •- Non-diabetic patients with a history of CME will be excluded from participation in the study.
- •Exclusion criteria for diabetic patients
- •- Macular edema with a CSMT =450 µm;
- •- Very severe NPDR or proliferative DR requiring panretinal photocoagulation or vitrectomy;
- •- Vitreous haemorrhage present during preoperative visit(s);
- •- Cerebrovascular accident (CVA), myocardial infaction (MI) or other thromboembolic events in the previous 3 months;
- •- A history of recurrent thromboembolic events;
- •- A history of severe systemic bleeding in the previous 3 months;
- •- Major surgery in the previous 3 months;
- •- History of glaucoma;
研究者
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