EUCTR2009-014054-14-GB进行中（未招募）1 期
Comparison of the Safety of Intracameral Levofloxacin to intracameral Cefuroxime for the prevention of endophthalmitis in cataract surgery (SILC) - Safety of intracameral levofloxacin in cataract surgery (version 2)
Guys' and St Thomas' NHS Foundation Trust, Joint Clinical Trials Office0 个研究点目标入组 30 人开始时间: 2010年6月7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
- 30
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
- •Patients requiring cataract surgery in both eyes attending the ophthalmology outpatient clinics at St Thomas' Hospital.
- •Sex - male or female of non-child bearing potential. This includes post menopausal women, or those who have had a hysterectomy or bilateral oophorectomy.
- •Age 20-100
- •Ability to comply with investigations and followup schedule.
- •Clinically normal corneal and retinal examination.
- •Pupils which dilate to 6mm or more per operatively.
- •Past ocular history – no history of long term ocular condition, long term use of ocular medications or ocular surgery.
- •Same surgeon to operate on both eyes.
- •Patients must give informed written consent in order to participate in the study. Non English speakers will be offered an interpreter.
- •Absence of exclusion factors as below
- •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
- •Unilateral cataract, very dense (brunescent or white) cataracts
- •Significant difference in corneal thickness, endothelial cell count or macular thickness of >20% at baseline between the two eyes
- •Past ocular history in either eye of
- •- pre-existing ocular conditions (glaucoma, retinal disease, clinically significant age related macula disease, uveitis, corneal disease)
- •- previous ocular surgery
- •- surgical complications in either eye
- •Diabetes requiring treatment.
- •Medications – use of long term topical eye drops with the exclusion of lubricant drops; use of tamsulosin (known to cause intraoperative floppy iris syndrome)
- •Allergies – to fluoroquinolones, cephalosporins
- •Patients unable to give informed consent or are unable to understand the requirements of the trial.
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