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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
Site 01
Zlín, Czech Republic, Czechia
RECRUITINGPercentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better
Time frame: Assessed for approximately 90 days
Percentage of participants with binocular Uncorrected Distance Visual Acuity of 20/40 or better
Time frame: Assessed for approximately 90 days
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 days
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 days
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 days
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 days
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 days
Incidence of Adverse Events
Percentage of eyes with treatment emergent adverse events occurred per event type
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Time frame: Assessed from 0-90 days