Wavefront-guided Photorefractive Keratectomy (PRK) Versus Wavefront-guided Lasik for Myopia

April 3, 2022 updated by: Edward E. Manche, Stanford University

A Prospective Randomized Eye to Eye Comparison of Fellow Eyes Undergoing Lasik With the IntraLase(TM) FS Versus PRK

A prospective comparison of eyes undergoing wavefront-guided LASIK in one eye and wavefront-guided PRK in their fellow eye for myopia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a research study comparing the outcomes of LASIK surgery to PRK surgery for nearsightedness when using the two different procedures. You will have one eye treated with LASIK using the Intralase FS laser and your other eye treated with PRK. You will be one of 100 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 200 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) in one eye and photorefractive keratectomy (PRK) in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives LASIK and which eye receives PRK will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will know which eye is being treated with which procedure. The randomization will determine only whether your right or left eye is treated with the LASIK procedure. The other eye will be treated with PRK. You have a fifty percent chance of having your left eye treated with LASIK as your right eye. Subjects will undergo either bilateral (both eyes at once) wavefront (a more precise custom laser system) guided LASIK and PRK treatments using the VISX Star S4 excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo LASIK and PRK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first six months of this study. If you elect to undergo a retreatment of your LASIK or PRK surgery prior to the 6-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date.

Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.

Study Type

Interventional

Enrollment (Actual)

34

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects age 21 and older with healthy eyes.
  • Nearsightedness between -0.75 diopters and -7.00 diopters with or without astigmatism of up to -3.50 diopters.

Exclusion Criteria:

  • Subjects under the age of 21.
  • Patients with thin corneas.
  • Patients with topographic irregularities.
  • Patients with keratoconus.
  • Patients with autoimmune diseases.
  • Patients who are pregnant or nursing.
  • Patients must have similar levels of nearsightedness in each eye. They can not be more than 1.0 diopter of difference between eyes.
  • Patients must have similar levels of astigmatism in each eye. They can not have more than 1.0 diopter of difference between eyes.

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Wavefront-guided PRK
Procedure: Photorefractive keratectomy
One eye undergoes wavefront-guided PRK with the Visx S4 CustomVue excimer laser.
Other Names:
  • PRK, CustomVue, Wavefront-guided
Procedure: Laser in-situ keratomileusis
One eye undergoes wavefront-guided LASIK using the Visx S4 excimer laser.
Other Names:
  • LASIK, CustomVue, Visx, Intralase FS60
ACTIVE_COMPARATOR: Wavefront-guided LASIK
Procedure: Photorefractive keratectomy
One eye undergoes wavefront-guided PRK with the Visx S4 CustomVue excimer laser.
Other Names:
  • PRK, CustomVue, Wavefront-guided
Procedure: Laser in-situ keratomileusis
One eye undergoes wavefront-guided LASIK using the Visx S4 excimer laser.
Other Names:
  • LASIK, CustomVue, Visx, Intralase FS60

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in uncorrected visual acuity
Time Frame: Baseline to one year
Baseline to one year
Changes in best spectacle corrected visual acuity
Time Frame: Baseline to one year
Baseline to one year
Changes in 25 and 5% low contrast acuity
Time Frame: baseline to one year
baseline to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in quality of vision
Time Frame: baseline to one year
baseline to one year
Comparison of dry eye signs and symptoms between LASIK and PRK
Time Frame: baseline to one year
baseline to one year
Changes in higher order aberrations
Time Frame: Baseline to one year
Baseline to one year

Collaborators and Investigators

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

Sponsor

Stanford University

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)

August 1, 2006

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (ESTIMATE)

June 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-05192010-6082
  • SQL 97234

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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