Customized Laser Ablation: Comparing Results of LADAR Vision and VISX Platforms
Condition: Customized Laser Ablation
Study type: Observational

Summary: 
      To compare the results of two commercially available customized laser ablation devices.
    

Detailed description: 
      In the past few years, several custom laser ablation platforms have emerged in the
      marketplace but only two are currently approved by the FDA. They are the LADAR CustomLasik
      (Alcon: Ft. Worth, TX) and the VISX Wavefront System (VISX: Santa Clara, CA). Although both
      use the Hartmann-Shack wave sensing principle, there are some basic distinctions in wave
      capture and processing technology. Moreover, there are fundamental differences in as far as
      centration, registration, and ablation technology is concerned. Evaluating and comparing the
      results of these two systems in assorted categories of patients would help us select the
      appropriate laser platform for the patient.

      Once a patient has been scheduled to undergo customized laser ablation, they will have a
      routine preoperative examination. The following tests will be gathered and evaluated by the
      doctor in order to determine eligibility for the treatment. If the patient qualifies for
      custom laser ablation, this information will also be used for the study as long as they give
      written consent.

      Pre-operative Visit (Screening visit): Date of Visit, Patient Initials, Date of Birth, Sex,
      Race, Assessment of visual needs, Ocular history, History of contact lens wear, Medical
      history, Allergies to food and drugs, Medication, family history, Distance and Near Vision
      (with and without correction), Auto-refraction, Refraction, eye dominance, Keratometry,
      Visual Acuity, Pupil size (bright and dim lighting), Afferent Pupillary Defect (ADP), Ocular
      motility, Ophthalmoscopy, Cycloplegic refraction, Pachymetry, Intaocular Pressure test,
      Custom Vue (VISX), LADARWave (LADAR), and Schirmers testing with anesthetic. Typically, these
      procedures are employed as part of "standard of care" for patients who are seeking custom
      LASIK treatment. Furthermore, there will be two additional procedures that will be performed
      as "reseach" measures . These are visual acuity with an Early Treatment Diabetic Retinopathy
      Study (ETDRS) vision chart and contrast sensitivity.

      Post-Operative visits (Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12): ETDRS Visual
      Acuity, contrast sensitivity along with a questionnaire pertaining to the study patients
      visual problems and experience will be completed by the patient at week 1 and after each
      visit thereafter. These procedures are intended as part of research.

      Additional data gathered as part of "standard of care" will include: date of visit, patient
      initials, visual acuity, refraction, Intraocular Pressure (discretion of physician), Custom
      Vue (VISX) and LADARWave. Both Custom Vue and LADAR measurements are taken at 3-month visit
      only!

      The research project proposes to compare the results of two FDA approved laser ablation
      treatment methods. While both treatment modalities are considered standard of care for those
      who decide to perform customized laser treatment, the "comparison" is intended as part of
      this research project.
    

Intervention name(s): Comparison of LADAR CustomLasik and VISX Wavefront System custom laser ablation devices
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Refractive Surgery Eligible Candidates
      
Keywords: LADARWave™; WaveScan Wavefront™ Systems