Bausch + Lomb Initiates First Clinical Trial for Technolas Teneo Excimer Laser in the United States
Bausch + Lomb announced that it has initiated the first in a series of U.S. clinical trials to evaluate the safety and efficacy of the Technolas Teneo excimer laser for vision correction surgery for myopia and myopic astigmatism.
“This is an exciting milestone for our organization, as it’s the first step on the road to filing for regulatory approval for the Teneo laser in the United States,” Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb, said in a company news release. “Teneo has been well received and widely adopted in more than 50 markets globally as one of the most versatile lasers on the market with the added benefit of a compact footprint, and we look forward to bringing this technology to surgeons and their patients in the United States, as well.”
This pivotal clinical trial is a multicenter, prospective, open-label, non-randomized study being conducted in the United States, evaluating the effectiveness of the Technolas Teneo 317 (model 2) excimer laser in LASIK surgery for myopia or myopic astigmatism. Participants in the study will undergo safety and efficacy evaluation at the time when refractive stability has been achieved (study endpoint).
