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

January 31, 2025 updated by: Abbott Medical Optics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Univerisity of Miami Bascom Palmer Eye Institute
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Kraff Eye Institute
    • Missouri
      • Chesterfield, Missouri, United States, 63017-5065
        • Pepose Vision Institute
      • Kansas City, Missouri, United States, 66211
        • Durrie Vision
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Coleman Vision
    • Texas
      • Nacogdoches, Texas, United States, 75965
        • Lehmann Eye Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • The Eye Center
    • Washington
      • Renton, Washington, United States, 98057
        • King LASIK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: wave-front guided LASIK
Device: LASIK
Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
Time Frame: 3 Months
< 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
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Time Frame: 3 Months
85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Optics

Investigators

  • Study Director: Kendra Hileman, PhD, Abbott Medical Optics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2012

Primary Completion (Actual)

November 22, 2016

Study Completion (Actual)

November 22, 2016

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimated)

August 30, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR-112-IDMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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