Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism

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. Identifier: NCT01675492
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

Condition or disease Intervention/treatment Phase
Astigmatism Device: LASIK Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 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 Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System
Actual Study Start Date : December 6, 2012
Actual Primary Completion Date : November 22, 2016
Actual Study Completion Date : November 22, 2016

Arm Intervention/treatment
Experimental: wave-front guided LASIK Device: LASIK
Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System

Primary Outcome Measures :
  1. Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 3 Months ]
    < 5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters

Secondary Outcome Measures :
  1. Uncorrected Visual Acuity (UCVA) of 20/40 or Better [ Time Frame: 3 Months ]
    85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

Information from the National Library of Medicine

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

Inclusion Criteria:

  • At least 18 years of age at the time of pre-operative exam
  • Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
  • Demonstration of refractive stability
  • Anticipated post-operative stromal bed thickness of at lest 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 identifier (NCT number): NCT01675492

United States, Florida
Univerisity of Miami Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Illinois
Kraff Eye Institute
Chicago, Illinois, United States, 60602
United States, Missouri
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017-5065
Durrie Vision
Kansas City, Missouri, United States, 66211
United States, New Mexico
Coleman Vision
Albuquerque, New Mexico, United States, 87109
United States, Texas
Lehmann Eye Center
Nacogdoches, Texas, United States, 75965
United States, Virginia
The Eye Center
Fairfax, Virginia, United States, 22031
United States, Washington
Renton, Washington, United States, 98057
Sponsors and Collaborators
Abbott Medical Optics
Study Director: Kendra Hileman, PhD Abbott Medical Optics

Responsible Party: Abbott Medical Optics Identifier: NCT01675492     History of Changes
Other Study ID Numbers: STAR-112-IDMA
First Posted: August 30, 2012    Key Record Dates
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Abbott Medical Optics:

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases