Status:
COMPLETED
Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery
Lead Sponsor:
City, University of London
Collaborating Sponsors:
The European Society of Cataract and Refractive Surgeons(ESCRS)
Santen Gmbh
Conditions:
Endophthalmitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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% ...
Detailed Description
Cataract extraction with intra-ocular lens implantation is the most commonly performed surgical procedure in the elderly population in Europe. The frequency varies in different European Union (EU) cou...
Eligibility Criteria
Inclusion
- All patients, including diabetics, undergoing routine cataract surgery in each unit taking part in the study
Exclusion
- Patients who do not wish to take part in the trial
- Patients allergic to penicillins and cephalosporins.
- Long-term nursing home patients
- Patients with only one eye
- Pregnancy.
- Children less than 18 years old.
- All severely 'at-risk' groups for infection including:
- Severe atopic keratoconjunctivitis;
- Severe active blepharitis;
- Ocular cicatricial pemphigoid.
- Patients with complicated cataracts such as traumatic or subluxated
- Patients having combined operations with cataract surgery such as trabeculectomy or a corneal graft.
- Patients known to be allergic to povidone iodine (very rare) or any other known hypersensitivity to any components of the study medications.
- Patients who are incapacitated mentally and incapable of giving consent.
- Patients with severe thyroid disease
- Open infection anywhere, infection of lacrimal drainage channels or infection around the eye
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
35000 Patients enrolled
Trial Details
Trial ID
NCT00136344
Start Date
September 1 2003
End Date
May 1 2006
Last Update
February 12 2016
Active Locations (24)
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1
University Eye Clinic, Paracelsus Private Medical University
Salzburg, Austria
2
University Hospital Antwerp, UZA Ophthalmology
Antwerp, Belgium
3
University of Gent, Universitaire Zeikenhuis
Ghent, Belgium
4
Jan Yperman Ziekenhuis
Ieper, Belgium