Clinical Investigation iDesign System With 1.3-PRESBY Treatment and STAR S4 IR™ Excimer Laser System

Exclusion criteria

• . Women who are pregnant, breast-feeding, intend to become pregnant, or are not using an adequate method of birth control \[examples are any form of barrier contraception (such as condom or diaphragm with contraceptive cream/jelly), birth control pills, hormonal implant, IUD, abstinence or surgical sterilization (tubal ligation, hysterectomy or vasectomy)\]. Note: Women who were pregnant or nursing may not be enrolled until 6 months after either delivery or have stopped nursing and there is documented refractive stability.
• . Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.
• . History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
• . Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
• . History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization \> 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.
• . Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.
• . Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.
• . Desire to have monovision.