A Study to Investigate the Effectiveness and Safety of the TENEO 317 Model 2 Excimer Laser to Treat Myopia with or without Astigmatism by Transepithelial Photorefractive Keratectomy
22 years of age or older at the time of the pre-operative examination.
Best distance corrected visual acuity (BCDVA) 20/25 or better in the study eye
Difference between manifest refractive spherical equivalent (MRSE) and the cycloplegic refraction of ≤ 0.75 D in the study eye.
Stable refraction (i.e., a change of ≤ 0.50 D in MRSE) for a minimum of 12 months before surgery, as verified by consecutive refractions, medical records, or prescription history.
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).
Use of medications that may increase risk to the subject or may confound the outcome of the study, including those known to affect wound healing (e.g., systemic corticosteroids, antimetabolites)
Evidence or history 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 excimer laser
DeviceTENEO 317 Model 2 excimer laser by Transepithelial Photorefractive Keratectomy
Maintenance of BCDVA -
lines lost \<5% of eyes with a loss of \>2 lines of BCDVA at the stability visit
Maintenance of BCDVA -
preservation 20/40 \<1% of eyes with a BCDVA of 20/20 or better preoperatively that have a BCDVA worse than 20/40 at the stability visit
Induced manifest refractive astigmatism
\<5% of eyes with induced manifest refractive astigmatism greater \>2 diopters at the stability visit
Induced manifest refractive astigmatism
\< 1% of eyes with serious adverse events by type of event observed through the final study visit.
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