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NCT05264623 · ClinicalTrials.gov registry record · NA
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
A NA study of Hyperopia, sponsored by Bausch & Lomb Incorporated.
- Active
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 9
- Study locations
NCT05264623: Active NA study of Hyperopia, sponsored by Bausch & Lomb Incorporated.
NCT05264623 is a NA study of Hyperopia that is active but no longer recruiting, run by Bausch & Lomb Incorporated. The registered enrollment target is 140 participants, above the 110-participant average among 10 other Hyperopia trials with a reported enrollment target (27% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05264623, a NA study of Hyperopia, is active but no longer recruiting, sponsored by Bausch & Lomb Incorporated.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 9
- Study locations
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 |
What the registry record for NCT05264623 still lists
NCT05264623 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 110-participant average among 10 other Hyperopia trials with a reported enrollment target (27% higher).
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.
NCT05264623 lists 9 locations in 8 states (Minnesota, California, Florida).
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.
What interventions are being tested in trial NCT05264623?
The interventions under investigation include: TENEO 317 Model 2 excimer laser (DEVICE).
Who is sponsoring clinical trial NCT05264623?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Hyperopia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05264623's enrollment target sits among peer trials
140 4th of 10 higher than 7 of 10 other Hyperopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperopia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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