ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery: Case for a European multicenter study.
OBJECTIVE
To present the development and design of the European Society of Cataract & Refractive Surgeons multicenter study of the prevention of postsurgical infective endophthalmitis after phacoemulsification and to describe the process for its successful implementation and conduct.


METHODS
Twenty-four ophthalmology units and eye clinics in Austria, Belgium, Germany, Italy, Poland, Portugal, Spain, Turkey, and the United Kingdom, with an administrative office in Ireland, coordinating center in England, and data management and statistical unit in Scotland.


METHODS
This partially masked randomized placebo-controlled multinational clinical study was designed to evaluate prospectively the prophylactic effect of intracameral cefuroxime and/or perioperative topical levofloxacin on postoperative endophthalmitis after cataract surgery. Random allocation was based on a 2 x 2 factorial design that included participating centers as a class variable. Real-time electronic data collection monitored study progress and provided weekly outcome tables, monthly recruitment summaries, and quarterly analytical reports for the study's Data Monitoring Committee, which evaluated the safety and efficacy by Internet-based conferences.


RESULTS
A 2-year lead time was required to meet harmonized standards of clinical research in the European Union, obtain ministerial authorization in 3 countries, gain institutional approvals at 24 hospitals, and procure indemnity insurance for surgical centers. Informed consent instruments, designed to comply with national health policies, were translated into 8 languages. The use of information technology to collect study data enabled the organizers to evaluate individual eligibility at enrollment, adherence with study medications during and after surgery, and postoperative status during follow-up.


CONCLUSIONS
This international cooperative study provided the opportunity to estimate the current incidence of endophthalmitis after cataract surgery in Europe and determine whether 1 or both of 2 antimicrobial regimens reduces the risk for postsurgical intraocular infection.
Seal
David V
DV
European Society of Cataract & Refractive Surgeons, Dublin, Ireland.
Barry
Peter
P
Gettinby
George
G
Lees
Fiona
F
Peterson
Magnus
M
Revie
Crawford W
CW
Wilhelmus
Kirk R
KR
D000287:Administration, Topical; D000867:Anterior Chamber / Q000187:drug effects; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D002387:Cataract Extraction; D002444:Cefuroxime / Q000627:therapeutic use; D004311:Double-Blind Method; D009877:Endophthalmitis / Q000382:microbiology / Q000517:prevention & control*; D015818:Eye Infections, Bacterial / Q000382:microbiology / Q000517:prevention & control*; D006801:Humans; D007267:Injections; D064704:Levofloxacin; D015242:Ofloxacin / Q000627:therapeutic use; D011183:Postoperative Complications / Q000382:microbiology / Q000517:prevention & control*; D011446:Prospective Studies
D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D015242:Ofloxacin; D002444:Cefuroxime