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
← catalyst calendarNCT05264623 · readout in 93 d
Sponsored by Bausch & Lomb Incorporated (industry) · BLCO — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
140actual
Sites
9
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-11-15 | actual | When the study began enrolling |
| Primary completion | 2026-11-20 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-11-20 | estimated | The whole study's end, after follow-up |
| First posted | 2022-03-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hyperopia
Intervention
- Device: TENEO 317 Model 2 excimer laser
Primary outcomes
what the primary-completion date above is the date OFThe percentage of eyes with Uncorrected Distance Visual Acuity (UDVA) of 20/40 or better at the time of refractive stability
measured Up to 12 months
The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 0.50 Diopter of intended correction at the time of refractive stability
measured Up to 12 months
The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 1.00 Diopter of intended correction at the time of refractive stability
measured Up to 12 months
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