Wavefront-guided Versus Wavefront-optimized LASIK for Nearsightedness

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University
ClinicalTrials.gov Identifier:
NCT01138189
First received: June 3, 2010
Last updated: March 9, 2014
Last verified: March 2014
  Purpose

The purpose of the study is to compare the results of LASIK surgery when using wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser treatment in patients with nearsightedness with and without astigmatism


Condition Intervention
Myopia
Astigmatism
Procedure: Wavefront-guided LASIK
Procedure: Wavefront-optimized LASIK

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Eye to Eye Comparison of LASIK Using Wavefront-guided Treatment Versus Wavefront-optimized Treatment

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Changes in best corrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Changes in 5 and 25% contrast visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Refractive predictability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Uncorrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in higher order aberrations [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
  • Quality of vision measurement [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • Topographic analysis [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Wavefront-guided LASIK
    Wavefront-guided LASIK in one eye using the Allegretto excimer laser
    Other Name: Wavelight Allegretto Eye-Q 400 Hz excimer laser
    Procedure: Wavefront-optimized LASIK
    Wavefront-optimized LASIK in one eye using the Allegretto excimer laser
    Other Name: Wavelight Allegretto Eye-Q 400 Hz excimer laser
Detailed Description:

This is a research study comparing the outcomes of LASIK surgery for nearsightedness when using the two different excimer laser technologies. Patients will have both eyes treated with the Alcon WaveLight Allegretto excimer laser. You will be one of 150 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 300 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) using one laser technology in the first eye and the second laser technology in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives the wavefront guided technology and which eye receives the wavefront-optimized technology 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 each technology. The randomization will determine only whether your right or left eye is treated with the wavefront guided technology. The other eye will be treated with wavefront-optimized laser technology. You have a fifty percent chance of having your left eye treated with custom wavefront guided technology as your right eye. Subjects will undergo bilateral (both eyes at once) LASIK treatments using the Alcon WaveLight Allegretto excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo LASIK 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 twelve months of this study. If you elect to undergo a retreatment of your LASIK surgery prior to the 12-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
Sampling Method:   Non-Probability Sample
Study Population

Subjects age 21 and older with healthy eyes. Nearsightedness between -7.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.

Criteria

Inclusion Criteria:

  • Subjects age 21 and older with healthy eyes.
  • Nearsightedness between -7.50 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 excessively thin corneas.
  • Patients with topographic evidence of 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 3.0 diopter of difference between eyes.
  • Patients must have similar levels of astigmatism in each eye. They can not have more than 4.0 diopters of difference in nearsightedness or astigmatism between their two 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: NCT01138189

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

No publications provided

Responsible Party: Edward E. Manche, Stanford University School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01138189     History of Changes
Other Study ID Numbers: SU-05272010-6188, Stanford Protocol # 18692
Study First Received: June 3, 2010
Last Updated: March 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Wavefront-guided LASIK. Wavefront-optimized LASIK. Custom LASIK

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014