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A Study to Investigate the Safety and Effectiveness of the Technolas® TENEO 317 Model 2 Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Myopia or Myopic Astigmatism

NCT07377474 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-30

No results posted yet for this study

Summary

This will be a multicenter, prospective, open label, non-randomized, single arm study evaluating the safety and effectiveness of the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser when used in LASIK surgery to treat myopia or myopic astigmatism. One or both eyes of a subject may be treated so long as both eyes meet all inclusion/exclusion requirements.

Conditions

  • Myopic Astigmatism

Interventions

DEVICE

TENEO 317 Model 2 (1.28 US) Excimer Laser

Surgery to Treat Myopia or Myopic Astigmatism with Sphere between 0.00D and -1.00D

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Rosangela Sonner · Bausch & Lomb Incorporated

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377474 on ClinicalTrials.gov