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Essai clinique

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

NCT : NCT05264623 · COMPLETED

ID NCTNCT05264623
StatutCOMPLETED
Date de début2022-11-15
Achèvement2026-08-24
SponsorBausch & Lomb Incorporated (INDUSTRY)
First posted
Last updated

Résumé succinct

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.

Source officielle

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