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

Not Applicable

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
wavefront-guided PRK with iDesign	STAR S4 IR laser with iDesign	wavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

Locations (7): Naval Medical Center Portsmouth
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Portsmouth, Virginia, United States
Naval Hospital Camp Pendleton
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Camp Pendleton, California, United States
Joint Warfighter Refractive Surgery Center Wilford Hall Medical Center
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Lackland Air Force Base, Texas, United States
Naval Medical Center
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San Diego, California, United States
Warfighter Eye Center Malcolm Grow Medical Clinics and Surgery Center
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Andrews Air Force Base, Maryland, United States
William Beaumont Army Medical Center
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El Paso, Texas, United States
Naval Hospital Camp LeJeune
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Camp Lejeune, North Carolina, United States