Performance and Acceptability of VSS-R

Study Overview
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Brief Summary
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The results of this trial will demonstrate that AVSS software performs as intended and is acceptable in a clinical setting.

Detailed Description
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LASIK treatment across the range of myopia with or without astigmatism, hyperopia with or without astigmatism, and mixed astigmatism.

Official Title
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A Prospective Study to Evaluate the Performance and Acceptability of Advanced Variable Spot Scanning (AVSS) Ablations With the STAR S4 IR® Excimer Laser System

Conditions
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Refractive Error

Intervention / Treatment
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* Device: STAR S4IR LASIK with VSS-R ablation profile


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refractive Error<br> | Device: STAR S4IR LASIK with VSS-R ablation profile<br>* LASIK treatment targeted for emmetropia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better |  | 1 Year |