A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

December 3, 2022 updated by: Edward E. Manche

A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.

Study Type

Interventional

Enrollment (Actual)

137

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
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects age 21 and older.
  • Subjects with nearsightedness, farsightedness and/or astigmatism.

Exclusion Criteria:Autoimmune diseases.

  • Children.
  • Women pregnant or nursing.
  • Ectatic corneal disease.
  • Previous ocular surgery.

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Wavefront guided LASIK/PRK
Wavefront-guided LASIK/PRK
Procedure: LASIK and PRK
Wavefront-guided versus wavefront-optimized LASIK or PRK.
Other Names:
  • Allegretto Wave Eye-Q 400 Hz excimer laser
  • Visx CustomVue excimer laser
  • Laser in-situ keratomileusis
  • Photorefractive keratectomy
  • Wavefront-guided
  • Wavefront-optimized
Active Comparator: Wavefront optimized LASIK/PRK
Wavefornt optimized LASIK/PRK
Procedure: LASIK and PRK
Wavefront-guided versus wavefront-optimized LASIK or PRK.
Other Names:
  • Allegretto Wave Eye-Q 400 Hz excimer laser
  • Visx CustomVue excimer laser
  • Laser in-situ keratomileusis
  • Photorefractive keratectomy
  • Wavefront-guided
  • Wavefront-optimized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in best spectacle corrected visual acuity.
Time Frame: One year
One year
Changes in 25 and 5% low contrast visual acuity.
Time Frame: One year
One year
Improvement in uncorrected visual acuity
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in higher order aberrations.
Time Frame: One year
One year
Topographic changes.
Time Frame: One year
One year
Quality of vision changes.
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

Edward E. Manche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2009

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

December 3, 2022

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 3, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-04302009-2458

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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