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Bausch + Lomb's TENEO™ Excimer Laser Yields Positive Results in Clinical Trials

Bausch + Lomb's TENEO™ Excimer Laser Yields Positive Results in Clinical Trials

August 14, 2024

Bausch + Lomb recently published the results of a pivotal clinical trial for its TENEO™ Excimer Laser in the Journal of Refractive Surgery. This study, which played a crucial role in securing U.S. FDA approval for the device in January 2024, demonstrates the safety and efficacy of TENEO for LASIK vision correction in myopia and myopic astigmatism.

Clinical Trial Highlights

» The multicenter study involved 168 subjects who underwent LASIK surgery using the TENEO platform. Notably, surgeons utilized the TENEO software without nomogram adjustments, relying on an aspheric ablation algorithm based on manifest refraction.

» At the nine-month follow-up, 97.8% of eyes achieved an uncorrected distance visual acuity (UDVA) of 20/25 or better, with 92.7% of eyes reaching a residual refractive error within ±0.50 D. These results underscore the platform's consistent visual outcomes.

» The Patient-Reported Outcomes with LASIK (PROWL) questionnaire revealed a dramatic increase in patient satisfaction, from 27.7% preoperatively to 98.1% postoperatively.

» Curious about LASIK? Before diving into this groundbreaking medical device, make sure you know the facts. Discover the top 5 myths about LASIK surgery debunked and separate fact from fiction!

Innovative Features of TENEO

TENEO is the first excimer laser approved in the U.S. in nearly two decades, distinguished by its 1,740Hz eye-tracker, which operates more than three times faster than the laser's 500Hz repetition rate. This advanced tracking system helps ensure precise laser ablation, even with patient eye movements.

an image of a medical device for LASIK

The platform is designed with user and patient comfort in mind, featuring a compact design, a swiveling microscope, and an adjustable treatment bed to accommodate patients of all sizes. These ergonomic features, combined with its high-speed laser, streamline the surgical process and enhance overall patient experience.

Expert Insights

Lead author Dr. George Waring IV highlighted the platform's transformative potential in refractive surgery, noting that his clinical experience with TENEO mirrors the study’s positive outcomes. He emphasized that TENEO delivers outstanding visual and refractive results, making it a valuable tool for refractive surgeons in the U.S.

For more detailed information, visit Bausch + Lomb's official announcement.

What is Myopia?

Myopia, or nearsightedness, is a common refractive error where distant objects appear blurry while close objects are seen clearly. It occurs when the eye is too long or the cornea is too curved, causing light to focus in front of the retina. Myopia can progress with age, particularly during childhood and adolescence, and requires corrective lenses or refractive surgery, such as LASIK, for clear vision.

Learn more about myopia and its impact on vision.

What is Myopic Astigmatism?

Myopic astigmatism is a condition where the eye not only has myopia but also an irregular curvature of the cornea or lens, leading to distorted or blurred vision at all distances. This dual refractive error causes light to focus on multiple points in front of the retina. Treatment often involves specialized corrective lenses or procedures like LASIK to address both myopia and astigmatism simultaneously.