Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
ConditionHyperopia and Myopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBausch & Lomb GmbH
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.
Eligibility criteria
Qualifiers
Subjects already scheduled for bilateral refractive laser surgery targeting emmetropia (attempted MRSE is between and including -0.50 D and +0.50 D).
Minimum 18 years of age.
Have read, understood, and signed an informed consent form (ICF).
Have a stable refraction (i.e., a change of ≤ 0.50 D in sphere and cylinder) for both eyes as judged by the investigator.
Disqualifiers
Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns residual stroma thickness in any eye.
Tear Break-Up time (TBUT) <8 s in any eye.
Mesopic pupil size larger than the optical zone of the planned treatment for any eye.
History or evidence of active or inactive of corneal disease or infection in either eye (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent erosion syndrome, corneal dystrophy, etc.).
Trial design
Treatments tested in this trial
- Anterior treatment mode
- Anterior treatment mode
- Total treatment mode
Treatment groups
81 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov