SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)

Exclusion Criteria

• •1. Manifest cylinder of more than -3.00 D;
• •2. Estimated treatment depth is less than 250 microns from the corneal endothelium;
• •3. Eye to be treated is targeted for monovision;
• •4. Keratometry readings via Sim-K values less than 40.00 D;
• •5. Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
• •6. History of or current anterior segment pathology, including cataracts in the eye to be treated;
• •7. Clinically significant dry eye syndrome unresolved by treatment in either eye;
• •8. Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the either eye;
• •9. Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
• •10. Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
• •11. History of ocular herpes zoster or herpes simplex keratitis;
• •12. Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
• •13. Difficulty following directions or unable to fixate;
• •14. Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes;
• •15. History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP \> 21 mmHg in either eye;
• •16. History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
• •17. Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
• •18. History of known sensitivity to planned study medications;
• •19. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
• •20. Pregnant or lactating;
• •21. Anyone who has the potential to deploy or relocate during the follow-up period.
• •22. Systemic Medications that may confound the outcome of the study or increase risk to the subject, including but not limited to steroids, antimetabolites, etc.
• •23. Evidence of retinal vascular disease.
• •24. Glaucoma suspects by exam findings or family history.