ISRCTN31806847
Completed
Not Applicable
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 sites30 target enrollmentJuly 29, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Guys' and St Thomas' Hospital NHS Foundation Trust (UK)
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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