EUCTR2012-004873-14-DE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 1,135 人开始时间: 2015年3月6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
- 1,135
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 phakoemulsification.
- •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 927
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
- •antiglaucomatous medication or steroid-induced IOP elevation that
- •required IOP-lowering treatmeht
- •8. IOP > or = 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. hiatory of retinal vein occlusion
- •13. any macular pathology that might affect visual acuity, other than
- •diabetic macular edema
- •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
- •16. current use of topical NSAIDs or corticosteroids
- •17. use of systemic corticosteroids (> or = 20 mg prednisolone or
- •equivalence)
- •18. history of relevant adverse events, including serious adverse events
- •(SAE), occuring after administration of NSAIDs, acitylsalicylic acid,
- •sodium sulphite, corticosteroids or bevacizumab
- •19. contraindications for use of topical 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
- •1. macular edema with a CSMT > or = 450 µm
- •2. very severe NPDR or proliferative DR requiring panretinal
- •photocoagulation or vitrectomy
- •3. vitreous hemorrhage present during preoperative visit(s)
- •4. cerebrovascular incident, myocardial infarction 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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