Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery

NCT00136344 | Completed

• 1 other identifier: MREC Ref. no. 02/5/46
• Study Type: interventional
• Target: 35,000
• Locations: 9 countries
• Sites: 24

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% 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

Keywords

cataract surgery; phacoemulsification; post-operative endophthalmitis

Outcome Measures

Primary Outcomes (2)

• Prevention of post-operative endophthalmitis following phacoemulsification cataract surgery in Europe due to use of perioperative antibiotics

• Incidence of endophthalmitis in Europe following phacoemulsification cataract surgery

Secondary Outcomes (1)

• Effect of risk factors on the presentation of endophthalmitis in Europe following phacoemulsification cataract surgery

Interventions

Cefuroxime DRUG

Levofloxacin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• City, University of London: lead
• The European Society of Cataract and Refractive Surgeons(ESCRS): collaborator
• Santen Gmbh: collaborator

Study Sites (24)

University Eye Clinic, Paracelsus Private Medical University

Salzburg, Austria

Location

University Hospital Antwerp, UZA Ophthalmology

Antwerp, Belgium

Location

University of Gent, Universitaire Zeikenhuis

Ghent, Belgium

Location

Jan Yperman Ziekenhuis

Ieper, Belgium

Location

Centre Hospitalier Universitaire

Liège, Belgium

Location

Oogheelkunde

Melveren, Belgium

Location

Augenklinik Ahaus

Ahaus, Germany

Location

Azienda Ospedaliera di Desenzano del Garda

Desenzano, Italy

Location

Ospedale Borgo Trento

Verona, Italy

Location

Kierownik Katedry i Kliniki

Warsaw, Poland

Location

University Hospital

Coimbra, Portugal

Location

Instituto Oftalmologico VISSUM

Alicante, Spain

Location

La Candelaria University Hospital

La Candelaria, Tenerife, Spain

Location

Hospital Universitario de Canarias

La Laguna, Tenerife, Spain

Location

Hospital Oftalmologico Internacional

Madrid, Spain

Location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

Axminster Hospital

Axminster, United Kingdom

Location

West of England Eye Unit, Royal Devon & Exeter Hospital (Wonford)

Exeter, United Kingdom

Location

Ipswich Hospital

Ipswich, United Kingdom

Location

Moorfields Eye Outreach Unit, Northwick Park Hospital

London, United Kingdom

Location

Moorfields Eye Outreach Unit, St. George's Hospital

London, United Kingdom

Location

St. Thomas' Hospital

London, United Kingdom

Location

Oxford Eye Hospital

Oxford, United Kingdom

Location

Sunderland Eye Infirmary

Sunderland, United Kingdom

Location

Related Publications (3)

• Seal DV, Barry P, Gettinby G, Lees F, Peterson M, Revie CW, Wilhelmus KR; ESCRS Endophthalmitis Study Group. ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery: Case for a European multicenter study. J Cataract Refract Surg. 2006 Mar;32(3):396-406. doi: 10.1016/j.jcrs.2006.02.014.

  PMID: 16631046 BACKGROUND

• Barry P, Seal DV, Gettinby G, Lees F, Peterson M, Revie CW; ESCRS Endophthalmitis Study Group. ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery: Preliminary report of principal results from a European multicenter study. J Cataract Refract Surg. 2006 Mar;32(3):407-10. doi: 10.1016/j.jcrs.2006.02.021.

  PMID: 16631047 RESULT

• Endophthalmitis Study Group, European Society of Cataract & Refractive Surgeons. Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. J Cataract Refract Surg. 2007 Jun;33(6):978-88. doi: 10.1016/j.jcrs.2007.02.032.

  PMID: 17531690 RESULT

MeSH Terms

Conditions

Endophthalmitis

Interventions

Cefuroxime; Levofloxacin

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Peter Barry, FRCS

  ESCRS (European Society of Cataract and Refractive Surgeons)

  STUDY CHAIR

• Mary D'Ardis

  ESCRS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: September 1, 2003
• Study Completion: May 1, 2006
• Last Updated: February 12, 2016

Record last verified: 2007-06

Locations

DE (1); IT (2); PL (1); GB (8); PT (1); ES (4); AU (1); TU (1); BE (5)