Trial record 11 of 19 for:    Open Studies | "Hyperopia"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Abbott Medical Optics
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01675479
First received: August 28, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Hyperopia
Device: LASIK correction of hyperopic refractive errors
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 HYPEROPIC REFRACTIVE ERRORS WITH THE IDESIGN ADVANCED WAVESCAN STUDIO™ SYSTEM AND STAR S4 IR™ EXCIMER LASER SYSTEM

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Line loss 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 Best Spectacle Corrected Visual Acuity


Secondary Outcome Measures:
  • Uncorrected Visual Acuity (VA) 20/40 or better [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    85% of eyes with uncorrected visual acuity of 20/40 or better


Estimated Enrollment: 145
Study Start Date: December 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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: NCT01675479

Contacts
Contact: Kendra Hileman 714-247-8613 kendra.hileman@amo.abbott.com

Locations
United States, California
Maloney Vision Institute Recruiting
Los Angeles, California, United States, 90024
United States, Florida
University 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, Missouri
Pepose Vision Institute Recruiting
Chesterfield, Missouri, United States, 63017
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: NCT01675479     History of Changes
Other Study ID Numbers: STAR-111IDHP
Study First Received: August 28, 2012
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Medical Optics:
refractive
errors

Additional relevant MeSH terms:
Hyperopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2014