The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
7
Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction
Used for refractive error correction
Alcon Investigative Site
Sioux Falls, South Dakota, United States
Alcon Investigative Site
Houston, Texas, United States
Alcon Investigative Site
Dublin, Ireland
Alcon Investigative Site
Singapore, Singapore
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening, Up to Month 6 (post-operative)
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