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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

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: Bausch & Lomb Incorporated to Bausch & Lomb Incorporated Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 3 entries
    • Trial completed
    • Primary completion date changed from estimate of Nov 20, 2026 to Aug 24, 2026
    • Eligibility criteria expanded, about 32 words
  2. Re-verified, no change to tracked fieldsv11
  3. Primary and study completion dates: Aug 20, 2025 to Nov 20, 2026
    • Trial status: Completed to Active, Not Recruiting
    v10
  4. Trial status: Recruiting to Completed
    • Study sites: 12 to 9
    • Primary and study completion dates changed from estimate of May 29, 2025 to Aug 20, 2025
    • Eligibility criteria expanded, about 25 words
    v9
  5. Site details revised at 3 of 12 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary endpoints: 1 to 3
    • Study sites: 9 to 12
    • Eligibility criteria expanded, about 30 words
    v7
  2. Primary and study completion dates: Sep 2023 to May 29, 2025
    • Start date: Jun 30, 2022 to Nov 15, 2022
    v6
  3. 2 versions Re-verified since Jul 31, 2023, no change to tracked fieldsv4-v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2022 to Jun 30, 2022
    • Site details revised at 9 of 9 sites
    v3
  5. Start date: Apr 2022 to Jun 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05264623
Lead Sponsor Bausch & Lomb Incorporated
Conditions
(from sponsor)		 Hyperopia
Related terms Hyperopia
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov