EUCTR2017-001416-11-ES进行中（未招募）1 期
Assessment of macular thickness after non-traumatic cataract surgery associated to intracamerular injection of Cefuroxima prepared at the hospital vs Prokam.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 622
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
- •Adults patients of both genres aged between 18 and 99 years.
- •Patients with cataracts 2 or 3 graded,by the Established in the
- •classification of LOCS III.
- •Patients who have signed inform consent indicating that they have
- •been informed regarding all
- •the clinical trial aspects, or in the event that the subjects of the trial are
- •incapacitated, signature of consent by the family member or legally
- •designated representative.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •A. preoperative:
- •-Alergia or hypersensitivity to ß-lactámic antibiotic or to any of the
- •excipients of the clinical trial drugs.
- •-Pacientes with no proliferative diabetic retinopathy, moderate or
- •severe diabetic macular edema or diabetic retinopathy proliferation
- •(any grade).
- •- History of uveitis, macular degeneration associate in the Middle (AMD)
- •type of exudative or atrophic, diabetic retinopathy, vein occlusion or
- •central retinal vein branch, epiretinal membrane (SEM) and retinitis
- •pigmentosa.
- •-Patients with macular edema in OCT macular preoperatorio proofing
- •whatever the etiology.
- •- Patients with glaucoma treatment with prostaglandin analogsnot been
- •suspended at least one month before the surgery.
- •B. Post-operative:
- •- Intraoperative complications: posterior capsule rupture, vitreous LOST,
- •iris-vitreous incarceration.
- •- Postoperatory complications: lack of compliance of treatment of the sheduled postoperative.
- •- Lack of compliance of the protocol.
研究者
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