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The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UV-FS laser | Experimental | WaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WaveLight® Ultraviolet Femtosecond (FS) Laser System | Device | Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of optical treatment zone corneal haze | Corneal haze will be assessed on a scale of 0 to 4, where 0 = clear or no haze can be seen, and 4 = opacity is visible without slit lamp, greatly obscures iris detail. | Up to Month 6 (post-operative) |
| Mean change from screening in presence of disruption in the integrity of retinal layers in the macula | Retinal layer integrity will be assessed by a posterior segment ocular coherence tomography (OCT) scan of the study eye. Any disruption (change) in the retinal layers in the macula as compared to the screening scan will assess retinal integrity. | Screening, Up to Month 6 (post-operative) |
| Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure | Specular microscopy will be performed on the study eye and endothelial cell density will be recorded. | Screening, Up to Month 6 (post-operative) |
| Mean percentage change in lens opacification from screening to each visit post procedure | A Scheimpflug scan will be performed to evaluate any opacification of the crystalline lens in the study eye and a Pentacam Nucleus Staging (PNS) grade from 0 to 5 will be assigned. | Screening, Up to Month 6 (post-operative) |
| Mean percentage change in foveal thickness from screening to each visit post procedure | Foveal thickness will be assessed by a posterior segment OCT scan of the study eye. | Screening, Up to Month 6 (post-operative) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Surgical | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Sioux Falls | South Dakota | 57108 | United States | ||
| Alcon Investigative Site |
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| Laser Assisted Lenticular Extraction | Procedure | Used for refractive error correction |
|
|
| Houston |
| Texas |
| 77027 |
| United States |
| Alcon Investigative Site | Dublin | 18 | Ireland |
| Alcon Investigative Site | Singapore | 168751 | Singapore |