Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Recruiting
N/A
Interventional Study
Hyperopia and Myopia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 81 (estimated)
- Sponsor
- Bausch & Lomb GmbH · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subjects already scheduled for bilateral refractive laser surgery targeting emmetropia (attempted MRSE is between and including -0.50 D and +0.50 D).
2. Minimum 18 years of age.
3. Have read, understood, and signed an informed consent form (ICF).
4. Have a stable refraction (…
Contacts