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Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01675479
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.

Condition or disease Intervention/treatment Phase
Hyperopia Device: LASIK correction of hyperopic refractive errors Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
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 Hyperopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System
Study Start Date : December 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: wavefront-guided LASIK Device: LASIK correction of hyperopic refractive errors
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System




Primary Outcome Measures :
  1. Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 12 Months ]
    Hypothesis: <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 :
  1. Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better [ Time Frame: 12 Months ]
    Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675479


Locations
United States, California
Maloney Vision Institute
Los Angeles, California, United States, 90024
United States, Florida
University 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
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

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01675479     History of Changes
Other Study ID Numbers: STAR-111-IDHP
First Posted: August 30, 2012    Key Record Dates
Results First Posted: April 25, 2018
Last Update Posted: April 25, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plan

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Abbott Medical Optics:
refractive
errors

Additional relevant MeSH terms:
Refractive Errors
Hyperopia
Eye Diseases