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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01663363
First received: August 9, 2012
Last updated: August 14, 2014
Last verified: August 2014
  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:


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
Primary Completion Date: March 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
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: NCT01663363

Locations
United States, California
Contact Abbott Medical Optics for locations
Milpitas, California, United States, 95035
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Study Director: Kendra Hileman, PhD 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: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Medical Optics:
refractive
LASIK

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on October 23, 2014