Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™

Study Overview
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Brief Summary
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Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.

Official Title
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A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-guided PRK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and the Star S4 IR™ Excimer Laser System

Conditions
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Stable Myopic Refractive Error, With or Without Astigmatism

Intervention / Treatment
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* Device: STAR S4 IR laser with iDesign


Participation Criteria
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Eligibility Criteria
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NOTE: Enrollment open only to military personnel Inclusion Criteria: Signed informed consent and HIPAA authorization. Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D. Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA). Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere. Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12 month time period. Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment. Willing and capable of complying with follow-up examinations for the duration of the study. Exclusion Criteria: Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control. Concurrent use of systemic (including inhaled) medications that may impair healing. 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, active ophthalmic disease or abnormality, 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 this study. If either eye does not meet all inclusion criteria Desire to have monovision. Participation in any other clinical study, with the exception of the fellow eye in this study.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wavefront-guided PRK with iDesign<br>wavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser | Device: STAR S4 IR laser with iDesign<br>* Surgeons will perform wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better | At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia