This will be a multicenter, prospective, open label, non-randomized, single arm study evaluating the safety and effectiveness of the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser when used in LASIK surgery to treat myopia or myopic astigmatism. One or both eyes of a subject may be treated so long as both eyes meet all inclusion/exclusion requirements.
Are 22 years of age or older.
Have read, understood, and signed an ICF.
Have demonstrated stable refraction (i.e., a change of ≤ ± 0.5 D in sphere and cylinder) for a minimum of 12 months prior to surgery verified by consecutive refractions, medical records or prescription history.
Have myopic refractive error with or without astigmatism; sphere 0.00 D up to -1.00 D, cylinder between 0.00 D and -3.00 D; with a manifest refraction spherical equivalent (MRSE) between -.0375 D and -2.50 D.
Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in treatment depth less than 250 microns from corneal endothelium.
Acute or chronic disease or illness that would increase operative risk or confound the results of the study (e.g., dry eye, cataract, immuno-compromise, rheumatoid arthritis, clinically significant atopic disease, acne rosacea, autoimmune disease, endocrine disorders, lupus, systemic connective tissue disease, diabetes, or severe atopic disease).
History or evidence of retinal vascular disease
History or evidence of active corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye.
Single group
TENEO 317 Model 2 (1.28 US) Excimer Laser
DeviceSurgery to Treat Myopia or Myopic Astigmatism with Sphere between 0.00D and -1.00D
The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 0.50 D
The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 1.00 D
The percentage of eyes that achieve a UDVA of 20/40 or better
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This trial is not recruiting at the moment. You can still explore other options:
