Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery

This study has been completed.
Sponsor:
Collaborators:
The European Society of Cataract and Refractive Surgeons(ESCRS)
Santen Gmbh
Information provided by:
City University, London
ClinicalTrials.gov Identifier:
NCT00136344
First received: August 26, 2005
Last updated: June 7, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention
Endophthalmitis
Drug: Cefuroxime
Drug: Levofloxacin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Antibiotic Prophylaxis for Cataract Surgery Version 7e January 22 2003

Resource links provided by NLM:


Further study details as provided by City University, London:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Effect of risk factors on the presentation of endophthalmitis in Europe following phacoemulsification cataract surgery

Estimated Enrollment: 35000
Study Start Date: September 2003
Estimated Study Completion Date: May 2006
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) countries involving 2 to 7 per 1000 population per annum. A population with an ever-increasing proportion of the elderly is advancing this figure with numbers requiring surgery expected to increase by 70% by 2006. While technical advances (phacoemulsification) have enhanced the efficacy of the procedure, the possibility of serious post-operative infection with loss of vision remains the most important unsolved problem.

In the absence of scientific evidence, the European Society of Cataract and Refractive Surgeons (ESCRS) wishes to determine whether one currently developed method of delivering antibiotics intraocularly in Sweden is of benefit compared to surgery without the use of perioperative antibiotics, as currently practised in many European centres, or to the use of frequent application of topical antibiotic drops perioperatively. The ESCRS also wishes to assess possible risk factors for later endophthalmitis.

This study requires four groups of 8,750 patients - 35,000 in all - to demonstrate reductions of currently reported rates of endophthalmitis (approximately 0.3%) in patients where no intraocular antibiotics are used, or where they are used by the subconjunctival route. Other studies using intraocular vancomycin have reported results as low as 0.05%, but these studies were not standardised or controlled and the results were anecdotal. In addition, vancomycin should not be used for routine prophylaxis and should only be used as the antibiotic of 'last resort'.

This multi-centre randomised study involves 24 operating units in 8 EU countries (Austria, Belgium, England, Germany, Italy, Poland, Portugal and Spain) and Turkey. Results in 8,750 patients receiving an intracameral injection of antibiotic (cefuroxime) at the end of surgery will be compared to 8,750 patients receiving topical antibiotic (levofloxacin) prophylaxis before and at the end of surgery, 8,750 patients receiving the combination and 8,750 patients receiving neither regime; in addition, all patients will receive povidone iodine antiseptic prophylaxis prior to surgery and post-operative levofloxacin from days 1 to 6 to prevent wound infection.

This group size will be sufficiently large to ensure at least 80% statistical power to detect a reduction of incidence from 0.25% to 0.08% using 5% significance level tests.

Surgical data from all patients will be collected directly into computers based within each operating theatre and transmitted to a central server in Glasgow (University of Strathclyde). Follow-up data for the presence or absence of endophthalmitis will be collected from all patients at post-operative visits and similarly recorded on computers for transmission to the central server. Sophisticated techniques will be used to check all data as it is uploaded.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136344

Locations
Austria
University Eye Clinic, Paracelsus Private Medical University
Salzburg, Austria
Belgium
University Hospital Antwerp, UZA Ophthalmology
Antwerp, Belgium
University of Gent, Universitaire Zeikenhuis
Gent, Belgium
Jan Yperman Ziekenhuis
Ieper, Belgium
Centre Hospitalier Universitaire
Liege, Belgium
Oogheelkunde
Melveren, Belgium
Germany
Augenklinik Ahaus
Ahaus, Germany
Italy
Azienda Ospedaliera di Desenzano del Garda
Desenzano, Italy
Ospedale Borgo Trento
Verona, Italy
Poland
Kierownik Katedry i Kliniki
Warsaw, Poland
Portugal
University Hospital
Coimbra, Portugal
Spain
Instituto Oftalmologico VISSUM
Alicante, Spain
La Candelaria University Hospital
La Candelaria, Tenerife, Spain
Hospital Universitario de Canarias
La Laguna, Tenerife, Spain
Hospital Oftalmologico Internacional
Madrid, Spain
Turkey
Dokuz Eylul University
Izmir, Turkey
United Kingdom
Axminster Hospital
Axminster, United Kingdom
West of England Eye Unit, Royal Devon & Exeter Hospital (Wonford)
Exeter, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Moorfields Eye Outreach Unit, Northwick Park Hospital
London, United Kingdom
Moorfields Eye Outreach Unit, St. George's Hospital
London, United Kingdom
St. Thomas' Hospital
London, United Kingdom
Oxford Eye Hospital
Oxford, United Kingdom
Sunderland Eye Infirmary
Sunderland, United Kingdom
Sponsors and Collaborators
City University, London
The European Society of Cataract and Refractive Surgeons(ESCRS)
Santen Gmbh
Investigators
Study Chair: Peter Barry, FRCS ESCRS - European Society of Cataract and Refractive Surgeons
Principal Investigator: Mary D'Ardis ESCRS
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00136344     History of Changes
Other Study ID Numbers: MREC Ref. no. 02/5/46
Study First Received: August 26, 2005
Last Updated: June 7, 2007
Health Authority: United Kingdom: National Health Service

Keywords provided by City University, London:
cataract surgery
phacoemulsification
post-operative endophthalmitis

Additional relevant MeSH terms:
Cataract
Endophthalmitis
Eye Infections
Infection
Eye Diseases
Lens Diseases
Anti-Bacterial Agents
Cefuroxime
Cefuroxime axetil
Ofloxacin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on July 20, 2014