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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University
ClinicalTrials.gov Identifier:
NCT01140594
First received: June 2, 2010
Last updated: March 9, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Myopia
Astigmatism
Procedure: Photorefractive keratectomy
Procedure: Laser in-situ keratomileusis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Prospective Randomized Eye to Eye Comparison of Fellow Eyes Undergoing Lasik With the IntraLase(TM) FS Versus PRK

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Improvement in uncorrected visual acuity [ Time Frame: Baseline to one year ] [ Designated as safety issue: No ]
  • Changes in best spectacle corrected visual acuity [ Time Frame: Baseline to one year ] [ Designated as safety issue: Yes ]
  • Changes in 25 and 5% low contrast acuity [ Time Frame: baseline to one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in quality of vision [ Time Frame: baseline to one year ] [ Designated as safety issue: Yes ]
  • Comparison of dry eye signs and symptoms between LASIK and PRK [ Time Frame: baseline to one year ] [ Designated as safety issue: Yes ]
  • Changes in quality of vision [ Time Frame: baseline to one year ] [ Designated as safety issue: No ]
  • Changes in higher order aberrations [ Time Frame: Baseline to one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: August 2006
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Photorefractive keratectomy
    One eye undergoes wavefront-guided PRK with the Visx S4 CustomVue excimer laser.
    Other Name: PRK, CustomVue, Wavefront-guided
    Procedure: Laser in-situ keratomileusis
    One eye undergoes wavefront-guided LASIK using the Visx S4 excimer laser.
    Other Name: LASIK, CustomVue, Visx, Intralase FS60
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01140594

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Edward E. Manche Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT01140594     History of Changes
Other Study ID Numbers: SU-05192010-6082, SQL 97234
Study First Received: June 2, 2010
Last Updated: March 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014