Enrollment begins in LASIK study of Technolas Teneo laser for hyperopia, astigmatism
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The first patient has been enrolled in a study of the Technolas Teneo excimer laser for LASIK surgery in patients with hyperopia 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 more than a decade,” Joe Gordon, president, Global Consumer, Surgical and Vision Care, Bausch + Lomb, said in the release. “The Teneo laser has been well received and is widely adopted in more than 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 endpoints will be determined through postoperative visits up to 24 months in 334 eyes undergoing LASIK surgery for correction of hyperopia and hyperopia with astigmatism.
The study is intended to support an eventual FDA premarket approval filing.
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