The first patient has been enrolled in a study of the Technolas Teneo excimer laser for LASIK surgery in farsighted patients with astigmatism, according to a press release.
“The initiation of this study is an important step toward our goal of bringing the Technolas Teneo excimer laser to the United States, where, if approved, it could become the first significant LASIK innovation in over a decade,” Joe Gordon, president, Global Consumer, Surgical and Vision Care, Bausch + Lomb, said in the statement. “The Teneo laser has been well received and is widely adopted in over 50 markets around the world as one of the most versatile lasers available with a compact footprint.”
In the multicenter, prospective, single-arm study, safety and efficacy parameters will be determined by postoperative visits up to 24 months in 334 eyes undergoing LASIK surgery for the correction of farsightedness and hyperopia. hyperopia with astigmatism.
The study is intended to support a potential premarket approval filing with the FDA.