Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
Phase 3
Completed
- Conditions
- Myopia
- Interventions
- Device: LASIK correction of myopic refractive errors
- Registration Number
- NCT01663363
- Lead Sponsor
- Abbott Medical Optics
- Brief Summary
The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description wavefront-guided LASIK LASIK correction of myopic refractive errors LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
- Primary Outcome Measures
Name Time Method Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) 6 Months
- Secondary Outcome Measures
Name Time Method Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better 6 Months
Trial Locations
- Locations (1)
Contact Abbott Medical Optics for locations
🇺🇸Milpitas, California, United States