Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2022-03-02; most recent amendment 2026-01-22.
Status change: Completed → Active, Not Recruiting 2025-09-16
Status change: Recruiting → Completed 2025-08-29
Status change: Not Yet Recruiting → Recruiting 2022-09-30
Trial Details
NCT Number NCT05264623
Lead Sponsor Bausch & Lomb Incorporated
Conditions Hyperopia
Enrollment 140 participants
Start Date 2022-11-15
Primary Completion 2026-11-20 (estimated)
Study Completion 2026-11-20 (estimated)
Updated on ClinicalTrials.gov 2026-01-23