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Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01663363
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : June 26, 2015
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myopia Device: LASIK correction of myopic refractive errors Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: wavefront-guided LASIK
LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
Device: LASIK correction of myopic refractive errors
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System



Primary Outcome Measures :
  1. Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better [ Time Frame: 6 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663363


Locations
United States, California
Contact Abbott Medical Optics for locations
Milpitas, California, United States, 95035
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Study Director: Kendra Hileman, PhD Abbott Medical Optics

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01663363     History of Changes
Other Study ID Numbers: STAR-110-IDMY
First Posted: August 13, 2012    Key Record Dates
Results First Posted: June 26, 2015
Last Update Posted: October 20, 2015
Last Verified: June 2015

Keywords provided by Abbott Medical Optics:
refractive
LASIK

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases