Comparison of the Safety of Intracameral Levofloxacin to intracameral Cefuroxime for the prevention of endophthalmitis in cataract surgery (SILC): a single-centre prospective double-blind randomised controlled trial

Guys' and St Thomas' Hospital NHS Foundation Trust (UK)0 个研究点目标入组 30 人开始时间: 2009年7月29日最近更新: 2015年1月13日

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•1. Patients undergoing routine cataract surgery attending the ophthalmology outpatient clinic at St Thomas' Hospital
•2. Aged 20-100 years
•3. Male or female (of non-childbearing potential)
•4. Clinically normal corneal and retinal examination
•5. Past ocular history - no history of long-term ocular condition, long-term use of ocular medications or ocular surgery
•6. Ability to comply with investigation and follow-up schedule
•7. Patients must give informed written consent in order to participate in the study. Non-English speakers will be offered an interpreter. All consents will be witnessed.

•1. Unilateral cataract, very dense (brunescent or white) cataracts
•2. Significant difference in corneal thickness, endothelial cell count/morphology or macular thickness of greater than 20% at baseline between the two eyes
•3. Past ocular history in either eye of:
•3.1. Pre-existing ocular conditions (glaucoma, retinal disease, uveitis, corneal disease)
•3.2. Previous ocular surgery
•3.3. Surgical complications in either eye
•4. Diabetes requiring treatment
•5. Medications: use of long-term topical eye drops with the exclusion of lubricant drops; use of tamsulosin (known to cause intra-operative floppy iris syndrome)
•6. Allergies to fluoroquinolones, cephalosporins
•7. Patients unable to give informed consent or are unable to understand the requirements of the trial

发起方

Guys' and St Thomas' Hospital NHS Foundation Trust (UK)