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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
NCT05264623 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE TENEO 317 Model 2 excimer laser
Study Locations (9)
Minnesota
- Site 101 — Bloomington
- Site 104 — Saint Louis Park
California
- Site 113 — Newport Beach
Florida
- Site 111 — Fort Myers
Nebraska
- Site 103 — Omaha
New York
- Site 102 — Amherst
Pennsylvania
- Site 112 — Pittsburgh
South Dakota
- Site 108 — Sioux Falls
Texas
- Site 106 — Cedar Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2022-11-15 |
| Est. Completion | 2026-11-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05264623
The ClinicalTrials.gov registry entry for NCT05264623 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hyperopia appearing as the primary indexed condition, and to 1 intervention — of which TENEO 317 Model 2 excimer laser is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05264623 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Minnesota, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05264623 about?
NCT05264623 is a clinical study titled "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". 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. B...
What is the current status of trial NCT05264623?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2022-11-15. Estimated completion is 2026-11-20.
What conditions does trial NCT05264623 study?
This clinical trial studies the following conditions: Hyperopia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05264623?
The interventions under investigation include: TENEO 317 Model 2 excimer laser (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05264623?
This trial is sponsored by Bausch & Lomb Incorporated, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05264623 being conducted?
This trial has 9 study locations across California, Florida, Minnesota, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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