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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperopic eyes and anterior treatment mode | Experimental |
| |
| Myopic eyes and anterior treatment mode | Experimental |
| |
| Myopic eyes and total treatment mode | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior treatment mode | Device | Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better | Assessed for approximately 90 days | |
| Percentage of participants with binocular Uncorrected Distance Visual Acuity of 20/40 or better | Assessed for approximately 90 days | |
| Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 0.50 D | Assessed for approximately 90 days | |
| Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 1.00 D | Assessed for approximately 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed for approximately 90 days |
| Preservation of Corrected Distance Visual Acuity (CDVA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sagan | Contact | +49 1726927757 | daniel.sagan@bausch.com |
| Name | Affiliation | Role |
|---|---|---|
| Natasa Orlic-Pleyer | Bausch & Lomb GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Recruiting | Zlín | Czech Republic | 76001 | Czechia |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Anterior treatment mode | Device | Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment |
|
| Total treatment mode | Device | Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment |
|
Percentage of eyes with CDVA loss > 2 lines (> 10 letters ETDRS scale) at visit 3 |
| 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 | Assessed for approximately 90 days |
| Incidence of Adverse Events | Percentage of eyes with treatment emergent adverse events occurred per event type | Assessed from 0-90 days |