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

This study is currently recruiting participants.
Verified January 2013 by Abbott Medical Optics
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01675492
First received: August 28, 2012
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Astigmatism
 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

Resource links provided by NLM:

U.S. FDA Resources

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


Estimated Enrollment: 97
Study Start Date: December 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2013 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675492

Contacts
Contact: Amelia Saliba 408-273-4158 amelia.saliba@amo.abbott.com
Contact: Mary Genetti 408-273-4151 mary.genetti@amo.abbott.com

Locations
United States, Florida
Univerisity of Miami Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
United States, Illinois
Kraff Eye Institute Recruiting
Chicago, Illinois, United States, 60602
United States, Minnesota
Minnesota Eye Consultants Recruiting
Bloomington, Minnesota, United States, 55432
United States, New Mexico
Coleman Vision Recruiting
Albuquerque, New Mexico, United States, 87109
United States, Virginia
The Eye Center Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
King LASIK Recruiting
Renton, Washington, United States, 98057
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Study Director: Leonard Borrmann, PharmD Abbott Medical Optics
  More Information

No publications provided

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
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

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 May 21, 2013