Nearsightedness Clinical Trials

• Subjects already scheduled for bilateral refractive laser surgery targeting emmetropia (attempted MRSE is between and including -0.50 D and +0.50 D).

• Minimum 18 years of age.

• Have read, understood, and signed an informed consent form (ICF).

• Have a stable refraction (i.e., a change of ≤ 0.50 D in sphere and cylinder) for both eyes as judged by the investigator.

• Have less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions at preoperative visit for both eyes.

• Study group 1 only: Have hyperopic refractive error with or without astigmatism; sphere between 0.00 D and 4.00 D, cylinder between 0.00 D and 3.00 D for both eyes; with a spherical equivalent (SE) between 0.50 D and 5.50 D for both eyes.

• Study groups 2 and 3 only: Have myopic refractive error with or without astigmatism; sphere between -8.00 D and 0.00 D, cylinder between 0.00 D and -4.00 D for both eyes; with a spherical equivalent (SE) between -10.00 D and -1.00 D for both eyes.

• Have CDVA of 20/25 (logMAR 0.1) or better in both eyes

• Have normal corneal topography as determined by the Investigator for both eyes.

⁃ Have discontinued use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the pre-operative examination, and through the day of surgery.

⁃ All contact lens wearers must demonstrate a stable refraction (within ± 0.50 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in both eyes and the axis of cylinder should not differ by more than 15 degrees from the baseline cycloplegic refraction for both eyes.

⁃ Have the ability to lie flat without difficulty.

⁃ Are willing and able to comply with the schedule for all post-surgery follow-up visits.