NCT05264623

Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism

A Study to Investigate the Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• 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 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in LASIK surgery to treat hyperopia with or without hyperopic astigmatism. Both eyes of a subject may be enrolled so long as both eyes meet all inclusion/exclusion requirements. Analysis of the primary effectiveness endpoint will be completed at refractive stability.

Conditions

• Hyperopia

Interventions

Type	Name	Description
DEVICE	TENEO 317 Model 2 excimer laser	TENEO 317 Model 2 excimer laser use for refractive surgery

Timeline

• Start date: 2022-11-15
• Primary completion: 2026-11-20
• Completion: 2026-11-20
• First posted: 2022-03-03
• Last updated: 2026-01-23

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study