Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial

Publication date: 18–24 January 2020Source: The Lancet, Volume 395, Issue 10219Author(s): Cedric Schweitzer, Antoine Brezin, Beatrice Cochener, Dominique Monnet, Christine Germain, Stephanie Roseng, Remi Sitta, Aline Maillard, Nathalie Hayes, Philippe Denis, Pierre-Jean Pisella, Antoine Benard, Cati Albou-Ganem, Jean-Louis Arné, Emilie Bardet, Antoine Benard, Catherine Bourreau, Antoine Brezin, Olivier Chatoux, Catherine CochardSummaryBackgroundCataract surgery is one of the most common operations in health care. Femtosecond laser-assisted cataract surgery (FLACS) enables more precise ocular incisions and lens fragmentation than does phacoemulsification cataract surgery (PCS). We hypothesised that FLACS might improve outcomes in cataract surgery compared with PCS despite having higher costs.MethodsWe did a participant-masked randomised superiority clinical trial comparing FLACS and PCS in two parallel groups (permuted block randomisation stratified on centres via a centralised web-based application, allocation ratio 1:1, block size of 2 or 4 for unilateral cases and 2 or 6 for bilateral cases). Five French University Hospitals enrolled consecutive patients aged 22 years or older who were eligible for unilateral or bilateral cataract surgery. Participants, outcome assessors, and technicians carrying out examinations were masked to the surgical treatment allocation until the last follow-up visit and a sham laser procedure was set up for participants randomly assigned to the ...
Source: The Lancet - Category: General Medicine Source Type: research