The new technology of femtosecond laser-assisted cataract surgery (FLACS) represents a potential paradigm shift in the delivery of cataract surgery world-wide. When evaluating a technique that may cause deep-rooted changes in the most common surgical procedure in the world many questions arise and more are likely in the immediate future.
Preliminary data for femtosecond laser-assisted cataract surgery show appropriate safety and efficacy and possible advantages over conventional cataract surgery. However there are few substantive comparative clinical trials.
The European Society of Cataract and Refractive Surgeons has pioneered the collection of surgical outcome data through its EUREQUO platform which was developed by ESCRS and co-financed by the European Union in 2008. The EUREQUO database currently contains the results of 1,00,000 cataract surgeries from across the world.
Using the EUREQUO platform, ESCRS proposes to collect outcome data on femtosecond laser-assisted cataract surgeries for comparison with outcomes of phacoemulsification surgeries in the EUREQUO database.
ESCRS Femtosecond Laser- Assisted Cataract Surgery (FLACS) Study
The purpose of this study is to compare the outcomes of femtosecond laser-assisted cataract surgery with conventional cataract surgery using phacoemulsification. The study will utilise the EUREQUO online platform for collecting surgical outcome data. ESCRS would like to invite doctors and clinics to contribute to the study.
This study is not a clinical trial. The study will compare the outcomes of two different treatment groups in terms of visual acuity, surgically induced astigmatism, complications and biometric error. Honest reporting is essential. Individual surgeons, clinics and patients will be anonymous in the database. Each contributing surgeon will be able to access only his own information online. Each clinic will be asked to provide a Registry Manager to supervise the study in that clinic and collect the data online.
The Registry Manager will be trained by the ESCRS for this study. To avoid bias from a learning curve each contributing surgeon must have performed over 50 femtosecond laser-assisted cataract surgeries prior to contributing to the study.
The study will include all available platforms for FLAC surgery but will not identify the platform in the database.
- Vision Eye Institute – Sydney, Australia
- Medipolis – Antwerp, Belgium
- Gemini Eye Clinic – Zlín, Czech Republic
- Universitätsklinikum Bochum, Augenklinik Germany
- Centre for Sight- London, Oxshott, East Grinstead, United Kingdom
- Semmelweis University – Budapest, Hungary
- CDI Milano, Italy
- Centro Oculistico ‘G. Perone’ – Saronno, Italy
- Ospedale Clinicizzato – Chieti, Italy
- D.O.M.A. srl – Rome, Italy
- CEMS – Verona, Italy
- Academic Hospital of Maastricht – The Netherlands
- Moorfields Eye Hospital – London , United Kingdom
- Istanbul Surgery Hospital Eye Clinic, Turkey
- IMO. Instituto Microcirugia – Barcelona, Spain
- Augenklinik Bellevue, Kiel – Germany
- Kaskaloglu Eye Hospital, Izmir-Turkey