Performance and Acceptability of VSS-R

This is an interventional treatment trial for Refractive Error Read More

Inclusion Criteria:

• Male or female, of any race, and at least 21 years old at the time of the pre-operative examination and signing the consent form.
• The refractive error, based on manifest refraction at the spectacle plane, of: MRSE up to -15.00 D with manifest cylinder between 0.00 and -6.00 D; MRSE up to +7.00 D, with manifest cylinder between 0.00 and 6.00 D; or Manifest cylinder (from 1.0 to 6.0 D) greater than the magnitude of sphere, and the manifest cylinder and sphere have opposite signs.
• BSCVA of 20/20 or better.
• UCVA of 20/40 or worse.
• Manifest refraction sphere within ± 0.75 D of cycloplegic refraction sphere (at the same vertex distance).
• Anticipated post-operative stromal bed thickness of at least 250 microns, based on pre-operative central corneal pachymetry minus the maximum treatment depth to be ablated and the intended flap thickness, and confirmed by intra-operative central corneal pachymetry.
• Anticipated post-operative keratometry value (based on pre-operative manifest refraction and keratometry) that is appropriate.
• A stable refractive error, based on an exam (or prescription) at least 12 months prior to the pre-operative examination and as compared to the pre-operative manifest refraction
• Subjects who have worn a contact lens in the operative eye must discontinue lens wear at least three (3) consecutive weeks prior to the pre-operative examination. If, upon review of pre-operative measurements, the Investigator determines that the corneal topography is within normal limits, surgery may be scheduled (within 60 days), with no contact lens wear permitted prior to the surgery.
• Willing and capable of returning for follow-up examinations for the duration of the study (6 months).

Exclusion Criteria:

• Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study, as determined by verbal inquiry.
• Concurrent use of topical or systemic 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 or implanted defibrillator.
• 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 > 1mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm, 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 videokeratography.
• Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
• Subjects with one eye that does not meet all inclusion criteria and does not fall within approved indications for treatment using the VISX® STAR S4 IR® Excimer Laser.
• Participation in any other clinical study.