At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde
In Brief
A Phase 3 clinical trial evaluating Cataract surgery with Phacoemulsification and Femtosecond laser-assisted cataract surgery for Cataract. Completed, enrolled 920 participants across 5 sites.
Detailed Summary
Cataract is the leading cause of blindness worldwide and cataract surgery is the most frequent surgery performed in France. A new technology, the femtosecond laser-assisted cataract surgery, has to be compared with phacoemulsification alone, the conventional cataract surgery, to determine the economic impact of femtosecond laser-assisted process for the French healthcare insurance.
Study Details
Timeline
Interventions
Each patients randomized in the phaco arm will undergo a conventional cataract surgery. Corneal incisions will be manually performed using the same calibrated blade and at the same location for all procedures of one surgeon. Phacoemulsification machine used to perform cataract surgery in each center will be the same for all patients included in the center. The IOL (IntraOcular Lens) used in each center will be the same for all patients treated in the center.
Each patients randomized in the femto arm will undergo a femtosecond laser assisted cataract surgery. Corneal incisions will be performed by the laser. Number, size and location of the incisions must be the same than in the phaco arm for all patients treated by one surgeon. Phacoemulsification machine used to remove the liquefied lens will be the same than in the phaco arm The IOL used in each center will be the same than in the phaco arm