Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery

NCT ID: NCT00136344

Last Updated: 2016-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-05-31

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.

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.

Conditions

Endophthalmitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Cefuroxime

Intervention Type: DRUG

Levofloxacin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The European Society of Cataract and Refractive Surgeons(ESCRS)

UNKNOWN

Sponsor Role: collaborator

Santen Gmbh

UNKNOWN

Sponsor Role: collaborator

City, University of London

OTHER

Sponsor Role: lead

Principal Investigators

Peter Barry, FRCS

Role: STUDY_CHAIR

ESCRS (European Society of Cataract and Refractive Surgeons)

Mary D'Ardis

Role: PRINCIPAL_INVESTIGATOR

ESCRS

Locations

University Eye Clinic, Paracelsus Private Medical University

Salzburg, , Austria

University Hospital Antwerp, UZA Ophthalmology

Antwerp, , Belgium

University of Gent, Universitaire Zeikenhuis

Ghent, , Belgium

Jan Yperman Ziekenhuis

Ieper, , Belgium

Centre Hospitalier Universitaire

Liège, , Belgium

Oogheelkunde

Melveren, , Belgium

Augenklinik Ahaus

Ahaus, , Germany

Azienda Ospedaliera di Desenzano del Garda

Desenzano, , Italy

Ospedale Borgo Trento

Verona, , Italy

Kierownik Katedry i Kliniki

Warsaw, , Poland

University Hospital

Coimbra, , Portugal

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

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

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

Countries

Austria; Belgium; Germany; Italy; Poland; Portugal; Spain; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 16631046 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16631047 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17531690 (View on PubMed)

Other Identifiers

MREC Ref. no. 02/5/46

Identifier Type: -

Identifier Source: org_study_id