Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City, University of London
• Collaborators: Santen Gmbh; The European Society of Cataract and Refractive Surgeons(ESCRS)
• Treatments: Anti-Bacterial Agents; Cefuroxime; Cefuroxime axetil; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• All patients, including diabetics, undergoing routine cataract surgery in each unit taking part in the study

Exclusion Criteria:

• 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