Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors
NCT ID: NCT01675479
Last Updated: 2021-12-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
167 participants
INTERVENTIONAL
2012-12-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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wavefront-guided LASIK
LASIK correction of hyperopic refractive errors
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Interventions
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LASIK correction of hyperopic refractive errors
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Eligibility Criteria
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Inclusion Criteria
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Abbott Medical Optics
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Surgical Vision Clinical Trials
Role: STUDY_DIRECTOR
Johnson & Johnson Surgical Vision
Locations
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Maloney Vision Institute
Los Angeles, California, United States
University of Miami Bascom Palmer Eye Institute
Miami, Florida, United States
Kraff Eye Institute
Chicago, Illinois, United States
Pepose Vision Institute
Chesterfield, Missouri, United States
Durrie Vision
Kansas City, Missouri, United States
Coleman Vision
Albuquerque, New Mexico, United States
Lehmann Eye Center
Nacogdoches, Texas, United States
The Eye Center
Fairfax, Virginia, United States
King LASIK
Renton, Washington, United States
Countries
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Other Identifiers
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STAR-111-IDHP
Identifier Type: -
Identifier Source: org_study_id