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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Abbott Medical Optics Identifier:
First received: August 28, 2012
Last updated: March 31, 2016
Last verified: January 2016
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

Condition Intervention Phase
Device: LASIK
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Line loss of less than two lines for Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    < 5% of eyes with a loss of > 2 lines of BSCVA

Secondary Outcome Measures:
  • Uncorrected Visual Acuity (UCVA) of 20/40 or better [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    85% of eyes with a UCVA of 20/40 or better

Enrollment: 126
Study Start Date: December 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: wave-front guided LASIK Device: LASIK
Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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: Leonard Borrmann, PharmD Abbott Medical Optics
  More Information

Responsible Party: Abbott Medical Optics Identifier: NCT01675492     History of Changes
Other Study ID Numbers: STAR-112-IDMA 
Study First Received: August 28, 2012
Last Updated: March 31, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Medical Optics:

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases processed this record on October 20, 2016