NCT04111757

A Study With Technolas® TENEO 317 Model 2 Excimer Laser to Treat Participants With Myopia or Myopic Astigmatism

A Study to Investigate the Safety and Effectiveness of the Technolas® TENEO 317 Model 2 Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Myopia or Myopic Astigmatism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to collect safety and effectiveness data for the Technolas Teneo 317 Model 2 excimer laser for LASIK correction in participants with myopia and myopic astigmatism.

Detailed description

Technolas TENEO 317 Model 2 excimer laser is a scanning excimer laser that operates at 193 nm ultraviolet wavelength to photoablate corneal tissue in order to achieve a refractive change. It is planned to enroll and treat up to 334 participant eyes, with an expectation that 300 study eyes will complete post-surgical follow-up for 6 months or until the point of achieved refractive stability. When a cohort of at least 300 eyes has achieved refractive stability at 6 months post-surgery, all other treated eyes that have not reached the 6-month examination may be discontinued at the Sponsor's request. Or, if 300 eyes achieve refractive stability at 9 months post-surgery, all other treated eyes that have not reached the 9-month examination may be discontinued

Conditions

• Myopia
• Myopic Astigmatism

Interventions

Type	Name	Description
DEVICE	Technolas® TENEO 317 Model 2	LASIK eye surgery

Timeline

• Start date: 2019-07-25
• Primary completion: 2021-08-06
• Completion: 2021-08-06
• First posted: 2019-10-01
• Last updated: 2024-06-14
• Results posted: 2024-06-14

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study