Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery
Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
City, University of London
Collaborators:
Santen Gmbh The European Society of Cataract and Refractive Surgeons(ESCRS)