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Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery

NCT00136344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35000

Last updated 2016-02-12

No results posted yet for this study

Summary

Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later.

It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.

Conditions

  • Endophthalmitis

Interventions

DRUG

Cefuroxime

DRUG

Levofloxacin

Sponsors & Collaborators

  • The European Society of Cataract and Refractive Surgeons(ESCRS)

    collaborator UNKNOWN

  • Santen Gmbh

    collaborator UNKNOWN

  • City, University of London

    lead OTHER

Principal Investigators

  • Peter Barry, FRCS · ESCRS (European Society of Cataract and Refractive Surgeons)

  • Mary D'Ardis · ESCRS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Completion
2006-05-31

Countries

  • Austria
  • Belgium
  • Germany
  • Italy
  • Poland
  • Portugal
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00136344 on ClinicalTrials.gov