EndophthalmitisNCT00136344
Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery
A study testing Cefuroxime and Levofloxacin in people with Endophthalmitis, run by City, University of London at 24 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- Cefuroxime and Levofloxacin
- How many people
- 35,000 participants
- Where
- 24 sitesin 9 countries
- Study dates
- Sep 2003to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients, including diabetics, undergoing routine cataract surgery in each unit taking part in the study
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
24 sites in 9 countries.
24 sites in 9 countries
United Kingdom8 sites
Axminster Hospital
Axminster
West of England Eye Unit, Royal Devon & Exeter Hospital (Wonford)
Exeter
Ipswich Hospital
Ipswich
Moorfields Eye Outreach Unit, Northwick Park Hospital
London
Moorfields Eye Outreach Unit, St. George's Hospital
London
St. Thomas' Hospital
London
Oxford Eye Hospital
Oxford
Sunderland Eye Infirmary
Sunderland
Belgium5 sites
University Hospital Antwerp, UZA Ophthalmology
Antwerp
University of Gent, Universitaire Zeikenhuis
Ghent
Jan Yperman Ziekenhuis
Ieper
Centre Hospitalier Universitaire
Liège
Oogheelkunde
Melveren
Spain4 sites
Instituto Oftalmologico VISSUM
Alicante
La Candelaria University Hospital
La Candelaria, Tenerife
Hospital Universitario de Canarias
La Laguna, Tenerife
Hospital Oftalmologico Internacional
Madrid
Italy2 sites
Azienda Ospedaliera di Desenzano del Garda
Desenzano
Ospedale Borgo Trento
Verona
Austria1 site
University Eye Clinic, Paracelsus Private Medical University
Salzburg
About this study
Official title: Antibiotic Prophylaxis for Cataract Surgery Version 7e January 22 2003
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.
Read the 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
- Being tested
- Cefuroxime, Levofloxacin
- Keywords
- cataract surgery, phacoemulsification, post-operative endophthalmitis
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefuroximeDrug
LevofloxacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startSep 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndophthalmitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 35,000 participants
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Cataract and Refractive Surgeons, Santen Gmbh
- Investigators
- Peter Barry, FRCS, Study chair, European Society of Cataract and Refractive SurgeonsMary D'Ardis, Principal investigator, ESCRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136344
- Sponsor's protocol ID
- MREC Ref. no. 02/5/46
- Status last verified
- Jun 2007
- First submitted
- 26 Aug 2005
- Last updated
- 12 Feb 2016
- Results posted
- No
Publications
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.
PubMed 16631046Barry 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.
PubMed 16631047Endophthalmitis 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.
PubMed 17531690
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Cataract Surgery Version 7e January 22 2003
- ClinicalTrials.gov ID
- NCT00136344
- Acronym / sponsor ID
- MREC Ref. no. 02/5/46
- Conditions
- Endophthalmitis
- Keywords
- cataract surgery, phacoemulsification, post-operative endophthalmitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35,000 participants
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Collaborators
- European Society of Cataract and Refractive Surgeons, Santen Gmbh
- Study start
- Sep 2003
- Study completion
- May 2006
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients, including diabetics, undergoing routine cataract surgery in each unit taking part in the study
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefuroxime | Drug | – |
| Levofloxacin | Drug | – |
Primary outcome
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
1 secondary outcome
Effect of risk factors on the presentation of endophthalmitis in Europe following phacoemulsification cataract surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Background: PubMed 16631046Seal 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.
- Results publication: PubMed 16631047Barry 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.
- Results publication: PubMed 17531690Endophthalmitis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Barry, FRCS study chair
European Society of Cataract and Refractive Surgeons
Mary D'Ardis principal investigator
ESCRS
24 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefuroxime and Levofloxacin in people with Endophthalmitis, run by City, University of London at 24 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United Kingdom, Belgium, Spain, Italy, Austria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of post-operative endophthalmitis following phacoemulsification cataract surgery in Europe due to use of perioperative antibiotics. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00136344, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.