Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
This trial is active, not recruiting.
|Treatment||lasik correction of myopic refractive errors|
|Sponsor||Abbott Medical Optics|
|Start date||August 2012|
|End date||August 2014|
|Trial size||345 participants|
|Trial identifier||NCT01663363, STAR-110-IDMY|
The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Line loss for Best Corrected Visual Acuity (BSCVA)
time frame: 6 Months
Uncorrected Visual Acuity (VA) 20/40 or better
time frame: 6 Months
Male or female participants at least 18 years old.
Inclusion Criteria: - 18 years of age or greater - Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better - Uncorrected visual acuity (UCVA) of 20/40 or worse - Less than 0.75D difference between cycloplegic and manifest refraction sphere. - Demonstration of refractive stability - Anticipated post-operative stromal bed thickness of at least 250 microns - Willing and capable of returning for follow-up examinations for the duration of the study. Exclusion Criteria: - Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study - Concurrent use of topical or systemic medications that may impair healing - History of any medical conditions that could affect wound healing - History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality - Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s) - Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
|Official title||A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser|
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