Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136344
Status:
COMPLETED
Last Update Posted:
2016-02-12
First Post:
2005-08-26
Brief Title:
Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery
Sponsor:
City University of London
Organization:
City University of London
Study Overview
Official Title:
Antibiotic Prophylaxis for Cataract Surgery Version 7e January 22 2003
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01 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 8750 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
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 8750 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 8750 patients - 35000 in all - to demonstrate reductions of currently reported rates of endophthalmitis approximately 03 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 005 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 8750 patients receiving an intracameral injection of antibiotic cefuroxime at the end of surgery will be compared to 8750 patients receiving topical antibiotic levofloxacin prophylaxis before and at the end of surgery 8750 patients receiving the combination and 8750 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 025 to 008 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
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 8750 patients - 35000 in all - to demonstrate reductions of currently reported rates of endophthalmitis approximately 03 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 005 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 8750 patients receiving an intracameral injection of antibiotic cefuroxime at the end of surgery will be compared to 8750 patients receiving topical antibiotic levofloxacin prophylaxis before and at the end of surgery 8750 patients receiving the combination and 8750 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 025 to 008 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None