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

This study is currently recruiting participants.
Verified February 2013 by Abbott Medical Optics
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01663363
First received: August 9, 2012
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Myopia
 Device: LASIK correction of myopic refractive errors
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Line loss for Best Corrected Visual Acuity (BSCVA) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    <5% of eyes with a loss of > 2 lines of Best Spectacle Corrected Visual Acuity


Secondary Outcome Measures:
  • Uncorrected Visual Acuity (VA) 20/40 or better [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    85% of eyes with uncorrected visual acuity of 20/40 or better


Estimated Enrollment: 345
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: wavefront-guided LASIK Device: LASIK correction of myopic refractive errors
Surgeons will perform wavefront-guided LASIK based upon measurement 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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663363

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, California
Contact Abbott Medical Optics for locations Recruiting
Milpitas, California, United States, 95035
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Study Director: Nicholas Tarantino, OD Abbott Medical Optics
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01663363     History of Changes
Other Study ID Numbers: STAR-110-IDMY
Study First Received: August 9, 2012
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Medical Optics:
refractive
LASIK

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013