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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Anterior treatment mode
DeviceLaser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
Anterior treatment mode
DeviceLaser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
Total treatment mode
DeviceLaser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
Treatment groups
81 Participants
are divided into 3 treatment groupsGroup A: Hyperopic eyes and anterior treatment modeExperimental treatment 1 intervention
Group B: Myopic eyes and anterior treatment modeExperimental treatment 1 intervention
Group C: Myopic eyes and total treatment modeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better
Time frame
Assessed for approximately 90 days2
Percentage of participants with binocular Uncorrected Distance Visual Acuity of 20/40 or better
Time frame
Assessed for approximately 90 days3
Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 0.50 D
Time frame
Assessed for approximately 90 days4
Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 1.00 D
Time frame
Assessed for approximately 90 daysSecondary outcomes
1
Preservation of Corrected Distance Visual Acuity (CDVA)
Percentage of eyes with CDVA worse than 20/40 at postoperative visit 3 if 20/20 or better preoperatively
Time frame
Assessed for approximately 90 days2
Preservation of Corrected Distance Visual Acuity (CDVA)
Percentage of eyes with CDVA loss \> 2 lines (\> 10 letters ETDRS scale) at visit 3
Time frame
Assessed for approximately 90 days3
Induced Manifest Refraction Astigmatism
Percentage of eyes that have a magnitude of postoperative manifest refractive astigmatism that increases from baseline cylinder by \> 2.00 D at postoperative visit 3
Time frame
Assessed for approximately 90 days4
Incidence of Adverse Events
Percentage of eyes with treatment emergent adverse events occurred per event type
Time frame
Assessed from 0-90 daysSponsors and contacts
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Source ClinicalTrials.gov