Trial is evaluating the use of the Technolas TENEO excimer laser for vision correction surgery for hyperopia with astigmatism.
Bausch + Lomb Corp. today announced that the company has enrolled the first patient in a study evaluating the safety and efficacy of the Technolas TENEO excimer laser for laser-assisted in situ keratomileusis (LASIK) vision correction surgery for hyperopia with astigmatism.
“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 a statement. "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."
According to the company, the multicenter, prospective, single arm, open-label, non-randomized clinical study will include up to 334 operative (study) eyes undergoing LASIK surgery for correction of hyperopia and hyperopic astigmatism. Investigators will determine safety and efficacy endpoints through a series of post-operative visits up to 24 months based on post-surgical observation.
“The demand for LASIK vision correction has risen significantly among our patients over the past few years, and refractive surgeons want options that meet the needs of their patients,” Ralph Chu, MD, study investigator, and founder and medical director of Chu Vision Institute and Chu Surgery Center, Bloomington, Minn., said in a news release. “This study represents an exciting opportunity to evaluate new technology that has the potential to help more hyperopic patients.”