Wavefront-guided PRK vs Wavefront-optimized PRK
Condition: Myopia; Astigmatism
MeSH terms: Myopia; Astigmatism
Study type: Interventional

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

Detailed description: 
      This is a research study comparing the outcomes of PRK 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 50 sighted patients at Stanford
      to undergo treatment in this clinical research trial. This will be a prospective, randomized,
      research study in which up to 100 consecutive eyes scheduled to undergo excimer laser photo
      refractive keratectomy (PRK) 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 not
      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) PRK 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 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. Patients will complete questionnaires preoperatively and postoperatively evaluating
      quality of vision and quality of life. 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 PRK 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.
    

Intervention name(s): Wavefront-guided PRK; Wavefront-optimized PRK
Intervention type(s): Procedure; Procedure
Intervention description(s): Wavefront-guided PRK; Wavefront-optimized PRK
Other intervention name(s): Alcon Wavelight Eye-Q 400 wavefront-guided PRK; Alcon Wavelight Eye-Q 400 wavefront-optimized PRK
Intervention MeSH terms: Dipivefrin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcon; Wavelight; PRK; Wavefront-guided; Wavefront-optimized; Myopia; Astigmatism