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Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2

NCT06997003 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-06-22

No results posted yet for this study

Summary

Prospective, post market clinical follow up study with a three months postoperative follow up to evaluate the visual and refractive outcomes of OCTAVIUS treatment when used as intended.

Conditions

  • Hyperopia and Myopia

Interventions

DEVICE

Anterior treatment mode

Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment

DEVICE

Anterior treatment mode

Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment

DEVICE

Total treatment mode

Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment

Sponsors & Collaborators

  • Bausch & Lomb GmbH

    lead INDUSTRY

Principal Investigators

  • Natasa Orlic-Pleyer · Bausch & Lomb GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Czechia

Study Locations

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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 NCT06997003 on ClinicalTrials.gov