Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
City University, London The European Society of Cataract and Refractive Surgeons(ESCRS) Santen Gmbh |
---|---|
Information provided by: | City University, London |
ClinicalTrials.gov Identifier: | NCT00136344 |
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: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Antibiotic Prophylaxis for Cataract Surgery Version 7e January 22 2003 |
Estimated Enrollment: | 35000 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | May 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
All severely 'at-risk' groups for infection including:
Austria | |
University Eye Clinic, Paracelsus Private Medical University | |
Salzburg, Austria | |
Belgium | |
Jan Yperman Ziekenhuis | |
Ieper, Belgium | |
Oogheelkunde | |
Melveren, Belgium | |
University of Gent, Universitaire Zeikenhuis | |
Gent, Belgium | |
University Hospital Antwerp, UZA Ophthalmology | |
Antwerp, Belgium | |
Centre Hospitalier Universitaire | |
Liege, Belgium | |
Germany | |
Augenklinik Ahaus | |
Ahaus, Germany | |
Italy | |
Ospedale Borgo Trento | |
Verona, Italy | |
Azienda Ospedaliera di Desenzano del Garda | |
Desenzano, Italy | |
Poland | |
Kierownik Katedry i Kliniki | |
Warsaw, Poland | |
Portugal | |
University Hospital | |
Coimbra, Portugal | |
Spain | |
Hospital Universitario de Canarias | |
La Laguna, Tenerife, Spain | |
La Candelaria University Hospital | |
La Candelaria, Tenerife, Spain | |
Instituto Oftalmologico VISSUM | |
Alicante, Spain | |
Hospital Oftalmologico Internacional | |
Madrid, Spain | |
Turkey | |
Dokuz Eylul University | |
Izmir, Turkey | |
United Kingdom | |
Sunderland Eye Infirmary | |
Sunderland, United Kingdom | |
Moorfields Eye Outreach Unit, Northwick Park Hospital | |
London, United Kingdom | |
Oxford Eye Hospital | |
Oxford, United Kingdom | |
West of England Eye Unit, Royal Devon & Exeter Hospital (Wonford) | |
Exeter, United Kingdom | |
Axminster Hospital | |
Axminster, United Kingdom | |
Ipswich Hospital | |
Ipswich, United Kingdom | |
St. Thomas' Hospital | |
London, United Kingdom | |
Moorfields Eye Outreach Unit, St. George's Hospital | |
London, United Kingdom |
Study Chair: | Peter Barry, FRCS | ESCRS - European Society of Cataract and Refractive Surgeons |
Principal Investigator: | Mary D'Ardis | ESCRS |
Study ID Numbers: | MREC Ref. no. 02/5/46 |
Study First Received: | August 26, 2005 |
Last Updated: | June 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00136344 |
Health Authority: | United Kingdom: National Health Service |
cataract surgery phacoemulsification post-operative endophthalmitis |
Bacterial Infections Eye Infections, Bacterial Eye Diseases Eye Infections Ofloxacin Endophthalmitis Lens Diseases |
Mycoses Cefuroxime Cefuroxime axetil Uveitis Cataract Suppuration |
Anti-Infective Agents Uveal Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Anti-Infective Agents, Urinary Infection Eye Infections, Fungal |
Renal Agents Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Uveitis, Suppurative Nucleic Acid Synthesis Inhibitors |