NCT07377474

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

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 With Sphere Between 0.00D and -1.00D

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This will be a multicenter, prospective, open label, non-randomized, single arm study evaluating the safety and effectiveness of the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser when used in LASIK surgery to treat myopia or myopic astigmatism. One or both eyes of a subject may be treated so long as both eyes meet all inclusion/exclusion requirements.

Conditions

• Myopic Astigmatism

Interventions

Type	Name	Description
DEVICE	TENEO 317 Model 2 (1.28 US) Excimer Laser	Surgery to Treat Myopia or Myopic Astigmatism with Sphere between 0.00D and -1.00D

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2026-01-30
• Last updated: 2026-01-30

Regulatory

• FDA-regulated device study