| Eligibility |
Inclusion Criteria:
- Are 22 years of age or older.
- Have read, understood, and signed an informed consent form (ICF).
- Have demonstrated stable refraction (for example, a change of =0.5 D in sphere and
cylinder) for a minimum of 12 months prior to surgery, verified by consecutive
refractions and/or medical records or prescription history.
- Have myopic refractive error with or without astigmatism; sphere between -1.0 D and
-10.00 D, cylinder between 0.0 D and -3.0 D; with a manifest refraction spherical
equivalent (MRSE) between -1.0 D and -11.50 D.
- Have uncorrected distance visual acuity (UDVA) of 20/40 or worse.
- Have manifest distance best spectacle corrected visual acuity (BSCVA) of 20/25
(logarithm of the minimum angle of resolution [logMAR] 0.1) or better in an operative
eye.
- Have equal to or less than 0.50 D spherical equivalent (SE) difference between
cycloplegic and manifest refractions at Visit 1 (pre-operative).
- Have normal corneal topography as determined by the Investigator.
- Have discontinued use of contact lenses for at least 2 weeks (for hard or toric
lenses) or 3 days (for soft contact lenses) prior to the pre-operative examination,
and through the day of surgery.
- All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as
determined by MRSE, on 2 consecutive examinations at least 1 week apart, in an eye to
be treated and the axis of cylinder should not differ by more than 15 degrees from the
baseline cycloplegic refraction.
- Have the ability to lie flat without difficulty.
- Are willing and able to comply with the schedule for all post-surgery follow-up
visits.
Exclusion Criteria:
- Participants 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.
- Eyes for which the baseline manifest subjective refraction exhibits a difference
greater than 0.50 D in sphere power, or a difference greater than 0.50 D in cylinder
power, or a difference in cylinder axis of more than 15 degrees compared to the
baseline cycloplegic subjective refraction. For manifest cylinder of less than 0.50 D,
the difference in cylinder axis will not be taken into consideration.
- Participants for whom the pre-operative assessment of the cornea indicates that one or
both eyes are not suitable candidates for treatment based upon the Investigator's
medical judgment.
- Have evidence of retinal vascular disease.
- Have a history of or have active corneal disease or infection (for example, recurrent
corneal erosion syndrome, herpes simplex, or herpes zoster keratitis) in either eye.
- Have a known sensitivity to any study medication.
- Have central corneal scars affecting visual acuity or unstable keratometry with
irregular mires in an eye considered for eligibility.
- Have keratoconus, subclinical or forme fruste keratoconus, corneal dystrophy, or other
corneal irregularity (for example, irregular astigmatism).
- Have visually significant or progressive cataract in an eye considered for
eligibility.
- Had previous intraocular or corneal surgery in an eye considered for eligibility that
might confound the outcome of the study or increase the risk to the participant.
- Use chronic medications by any administration route that may increase risk to the
participant or may confound the outcome of the study, including those known to affect
wound healing (for example, corticosteroids, antimetabolites).
- Are known to have acute or chronic disease or illness (for example, dry eye, cataract,
glaucoma, immuno-compromised, rheumatoid arthritis, clinically significant atopic
disease, acne rosacea) that would increase operative risk or may confound the results
of the study.
- Are taking medications contraindicated for LASIK such as isotretinoin (Accutane) or
amiodarone hydrochloride (Cordarone).
- Are known to be pregnant, lactating, or who plan to become pregnant during the course
of the study.
- Have known sensitivity to medications used for standard LASIK.
- Have the presence of systemic disease likely to affect wound healing, for example,
autoimmune disease, systemic connective tissue disease, diabetes, or severe atopic
disease.
- Are participating in any other ophthalmic clinical trial within 30 days of screening
or during this clinical trial.
- Have an ocular muscle disorder including a strabismus or nystagmus, or other disorder
affecting fixation.
- Have a history of or evidence of glaucoma or are a glaucoma suspect.
- Have eyes with mesopic pupil size >7.0 millimeters (mm).
- Have a Schirmer's pre-operative test without anesthesia <4 mm/5 minutes.
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