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

Myopia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04111757
Study type Interventional
Source Bausch & Lomb Incorporated
Contact
Status Completed
Phase N/A
Start date July 25, 2019
Completion date August 6, 2021
View Details
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