EUCTR2007-006228-36-ES进行中（未招募）不适用
Evaluación de la Eficacia y Seguridad de Azyter® (T1225) en la Profilaxis Antibiótica Perioperatoria (descontaminación de la superficie ocular) para la Cirugía de Catarata
aboratoires Théa0 个研究点目标入组 75 人开始时间: 2008年1月24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
- 75
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
- •-Signed and dated informed consent.
- •-Male or female aged from 18 to 80 years old.
- •-Uncomplicated cataract.
- •-Scheduled to undergo cataract surgery (phacoemulsification – foldable intra-ocular lens surgery with injector – clear corneal incision).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Surgical conditions in the eye to be operated:
- •-Combined surgery.
- •-Other cataract aetiologies than senile or pre-senile cataract.
- •Non-surgical conditions in the eye to be operated:
- •-Dacryocystitis and all others pathologies of tears drainage system.
- •-Inflammatory ocular disease (uveitis, herpetic keratitis).
- •-Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis).
- •-History of ocular traumatism, infection or inflammation within the last 3 months.
- •Ophthalmic condition in the contra lateral eye:
- •-Best corrected visual acuity < 1/10.
- •-Patient already included in the study for phakoexeresis.
- •-History of surgical complication (notably endophthalmitis)
- •Ophthalmic condition in either eye:
- •-Presence of glaucoma and/or ocular hypertension history,
- •-Presence of any other ocular pathology such as dry-eye syndrome, allergy in either eye likely to require a topical treatment from Day-15 to Day 5 conjunctival sampling.
- •Systemic/non ophthalmic conditions
- •None of the following criteria:
- •General history:
- •-Diabetes not controlled, Infectious diseases, Immunosuppressive diseases,
- •-Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc... and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study.
- •Allergic history:
- •-Known hypersensitivity to one of the components of the study medications or to any other macrolide antibiotic or to test products,
- •-Allergic rhinitis.
研究者
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