Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia

Inclusion Criteria:

1. Signed informed consent and HIPAA authorization.

2. At least 40 years of age at enrollment (date informed consent signed).

3. The refractive error of both subject's eyes, based on the iDesign refractionselected for treatment ("4.0 mm Rx calc" at 12.5 mm), must be myopic with or withoutastigmatism up to -6.00 D spherical equivalent (SE), with cylinder up to -3.00 D andminimum pre-operative myopia in their non-dominant eye at least as great as theirtargeted myopic retention.

4. At least one eye must require a myopic treatment.

5. Anticipated stromal bed thickness of at least 250 microns based on preoperativecentral corneal pachymetry minus the maximum treatment depth to be ablated (ascalculated by the iDesign plus the intended flap thickness).

6. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.

7. Require an add power of +1.25 D or more but not greater than +2.00 D at 40 cm.

8. Less than or equal to ±0.50 D difference between cycloplegic and manifest refractionsphere.

9. A stable refractive error (based on a previous exam, medical records, lensometry, orprescription that is at least 12 months prior to the preoperative manifestrefraction), as defined by a change of less than or equal to

• 0.50 D in MRSE (sphere and cylinder).

10. Subjects with a history of contact lens wear within the last 4 weeks mustdiscontinue lens wear in order to demonstrate refractive stability according to thefollowing (refractive stability is defined as a change of not more than 0.50 D inmanifest refraction sphere and cylinder as well as mean keratometry betweenmeasurements): After the Informed Consent process has been completed and subjectsare enrolled in the study:

• Rigid or extended wear contact lenses (toric or spherical) must be removed forat least 3 weeks and soft contact lenses (toric or spherical) for at least 2weeks prior to the first refraction used to establish stability.

• After abstaining from contact lens wear for designated time, two consecutivemanifest refractions and keratometric readings must be conducted at least 7days apart

• I If the subject/eye meets the refractive stability criteria, contact lens wearis not permitted for 2 weeks prior to surgery except as required to testmonovision acceptance as described below in the Study Procedures, Contact LensTrial section NOTE: Refractive stability needs to be confirmed only once duringpreoperative assessment

11. Agreement between manifest refraction (adjusted for optical infinity) and iDesignSystem refraction chosen for treatment, as follows:

• Spherical Equivalent: magnitude of the difference is less than 0.625 D.

• Cylinder: magnitude of the difference is less than or equal to 0.5 D.

• Cylinder Axis Tolerance: If either the manifest cylinder entered into theiDesign System or the iDesign cylinder selected for treatment is less than 0.5D, there is no requirement for axis agreement. When both cylinders have amagnitude of at least 0.5 D, the axis tolerance as determined by the iDesignsystem is linearly reduced from 15 degrees (0.5 D) to 7.5 degrees (7.0 D) basedon the average magnitude of both cylinders. Note: If the axis tolerance is notin the calculated range, the iDesign system will produce a warning and thisexam may not be used for treatment planning.

12. Willing and capable of complying with follow-up examinations for the duration of thestudy.

Exclusion Criteria:

1. Women who are pregnant, breast-feeding, or intend to become pregnant during thestudy. Note: Women who were pregnant or nursing may not be enrolled until 6 months aftereither delivery or have stopped nursing and there is documented refractivestability.

2. Concurrent use of systemic (including inhaled) medications that may impair healing,including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months oftreatment. NOTE: The use of inhaled or systemic corticosteroids, whether chronic oracute, within the past 6 months is deemed to adversely affect healing and subjectsusing such medications are specifically excluded from eligibility.

3. History of any of the following medical conditions, or any other condition thatcould affect wound healing: collagen vascular disease, autoimmune disease,immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrinedisorders (including, but not limited to unstable thyroid disorders and diabetes),lupus, and rheumatoid arthritis. NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration,severity, or control, will specifically exclude subjects from eligibility.

4. Subjects with a cardiac pacemaker, implanted defibrillator or other implantedelectronic device.

5. History of prior intraocular or corneal surgery (including cataract extraction),active ophthalmic disease or abnormality (including, but not limited to, symptomaticblepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1 mmfrom limbus), retinal detachment/repair, clinically significant lens opacity,clinical evidence of trauma, corneal opacity within the central 9 mm and visible ontopography, prior strabismus surgery, strabismus, or at risk for developingstrabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma orsuspected glaucoma. NOTE: Subjects with glaucoma, regardless of medication regimen or control, or an IOPgreater than 21 mmHg at screening, are specifically excluded from eligibility.

6. Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.

7. Known sensitivity or inappropriate responsiveness to any of the medications used inthe postoperative course.

8. Intolerance to monovision correction based on questionnaire responses to contactlens trial (refer to section Study Procedures, Contact Lens Trial below).

9. Concurrent participation in any other clinical trial, or participation in any otherclinical trial within the last 14 days.