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.
Setting
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 × 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.
Conclusion
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.
From the European Society of Cataract & Refractive Surgeons (Seal, Barry), Dublin, Ireland; the Department of Statistics and Modelling Science (Gettinby, Lees, Peterson, Revie), University of Strathclyde, Glasgow, United Kingdom; and the Cullen Eye Institute (Wilhelmus), Baylor College of Medicine, Houston, Texas, USA
Reprint requests to Peter Barry, ESCRS, Temple House, Temple Road, Blackrock, County Dublin, Ireland.
Funded by the European Society of Cataract & Refractive Surgeons, Dublin, Ireland, with support from Santen GmbH, Germering, Germany.
No author has a financial or proprietary interest in any material or method mentioned.
The Board of the ESCRS, through its current and recent officers and members, acknowledges several individuals: Peter Barry for conceiving the study and ensuring it became a reality; David Seal for his academic input, tenacity, and voluntary service; and Fiona Lees for meticulous collection and recording of data. The Board acknowledges the contribution of the partners and the doctors, nurses, pharmacists, microbiologists, secretaries, and assistants who have coped magnificently with the additional workload imposed on them by participation in the multicenter study. The Board also acknowledges the promptness and diligence with which the Data Management Committee consistently responded to the electronic information presented to them. In addition, the Board acknowledges the financial contribution of Santen. Finally, the Board acknowledges Mary D'Ardis, CEO, and the ESCRS staff for their unremitting enthusiasm and support.
ABSTRACT