NCT06997003

Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2

Evaluation of a New Customized Corneal Treatment for Laser Refractive Vision Correction Using the TENEO™ 317 Model 2

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Bausch & Lomb GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, post market clinical follow up study with a three months postoperative follow up to evaluate the visual and refractive outcomes of OCTAVIUS treatment when used as intended.

Conditions

• Hyperopia and Myopia

Interventions

Type	Name	Description
DEVICE	Anterior treatment mode	Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
DEVICE	Anterior treatment mode	Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
DEVICE	Total treatment mode	Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment

Timeline

• Start date: 2025-06-16
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-05-30
• Last updated: 2025-06-22

Locations

1 site across 1 country: Czechia