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Clinical Trials/ISRCTN31806847
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.

Registry
who.int
Start Date
July 29, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

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

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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