Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond Laser

This is an interventional treatment trial for Myopia Read More

Inclusion Criteria:

1. Male and female subjects age 22 years of age and older;
2. Myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder and MRSE ≤ -11.50 D in the eye to be treated;
3. A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eye to be treated;
4. A difference between cycloplegic and manifest refractions of < 0.75 D spherical equivalent in the eye to be treated;
5. UCVA worse than 20/40 in the eye to be treated;
6. BSCVA at least 20/20 in the eye to be treated;
7. Discontinue use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the preoperative examination, and through the day of surgery;
8. All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated;
9. Central corneal thickness of at least 500 microns in the eye to be treated;
10. Willing and able to return for scheduled follow-up examinations;
11. Able to provide written informed consent and follow study instructions in English

Exclusion Criteria:

1. Mesopic pupil diameter >8.0 mm;
2. Cylinder > -3.00 D;
3. Treatment depth is less than 250 microns from the corneal endothelium;
4. Eye to be treated is targeted for monovision;
5. Fellow eye has BSCVA worse than 20/40;
6. Keratometry readings via Sim-K values less than 40.00 D;
7. Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
8. History of or current anterior segment pathology, including cataracts in the eye to be treated;
9. Clinically significant dry eye syndrome unresolved by treatment in either eye;
10. 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 eye to be treated;
11. Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
12. Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
13. History of ocular herpes zoster or herpes simplex keratitis;
14. Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
15. Difficulty following directions or unable to fixate;
16. 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;
17. History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye;
18. History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
19. Immunocompromised or requires chronic systemic corticosteroids or other immunosuppresive therapy that may affect wound healing;
20. History of known sensitivity to planned study medications;
21. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
22. Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.