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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01675492
First received: August 28, 2012
Last updated: May 23, 2017
Last verified: May 2017
  Purpose
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

Condition Intervention
Astigmatism Device: LASIK

Study Type: Interventional
Study Design: 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

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 126
Actual Study Start Date: December 6, 2012
Study Completion Date: November 22, 2016
Primary Completion Date: November 22, 2016 (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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01675492

Locations
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
King LASIK
Renton, Washington, United States, 98057
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Study Director: Kendra Hileman, PhD Abbott Medical Optics
  More Information

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01675492     History of Changes
Other Study ID Numbers: STAR-112-IDMA
Study First Received: August 28, 2012
Results First Received: February 3, 2017
Last Updated: May 23, 2017

Keywords provided by Abbott Medical Optics:
Astigmatism
refractive
error
LASIK

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 21, 2017