A Prospective Contralateral Comparison of Ray-Tracing Guided LASIK (WaveLight® Plus LASIK) vs. Small Incision Lenticule Extraction (SMILE® Pro) Using VisuMax® 800, or Wavefront Optimized LASIK or Topography Guided LASIK (Contoura LASIK): A Three-Phase Visual Outcomes Study.
Hoopes Vision
Summary
This purpose of this study is to compare a new form of LASIK called Ray Tracing Guided LASIK to 3 other forms of corneal refractive surgery: 1. KLEx (KeratoLenticule Extraction) using the Zeiss Visumax 800 Laser, 2. WFO LASIK (Wavefront Optimized LASIK) using the Alcon EX500 Laser, and 3. Topography Guided LASIK (Contoura LASIK) also using the Alcon EX500 Laser.
Description
This is a prospective, randomized, simultaneous, contralateral eye study comparing visual outcomes for 4 different refractive technologies. This study will be conducted in 3 phases. Each phase will include at least 44 subjects undergoing refractive correction surgery for myopia or myopia with astigmatism. Each phase will compare Ray-Tracing LASIK to 1 of 3 other forms of corneal refractive surgery. The Phase 1 comparator will be KLEx (KeratoLenticule Extraction) using the Zeiss Visumax 800 Laser. The Phase 2 comparator will be WFO LASIK (Wavefront Optimized LASIK) using the Alcon EX500 Laser.…
Eligibility
- Age range
- 22–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age 22-50 at the time of consent 2. Diagnosis of myopia or myopia with astigmatism with Preoperative manifest spherical equivalent refraction of ≥ -2.00 and ≤ -9.00 D (-2.00 D through -9.00 D) 3. Preop Spherical component of ≥ -2.00 and ≤ -8.00 D (-2.00 D through -8.00 D) 4. Refractive Cylinder of ≤ -3.00 D (0.00 through -3.00 D) 5. BCVA of 20/20 or better in each eye (83 or more letters on the ETDRS Chart) 6. Subjects must have a stable refraction which is defined as a change in spherical equivalent no greater than 0.50 D comparing the screening visit manifest refracti…
Interventions
- DeviceRay-Tracing Guided LASIK
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
- DeviceKeratorefractive Lenticule Extraction (KLEx)
A form of corneal refractive surgery utilizing a femtosecond laser to create a lens shaped lenticule of corneal tissue that is removed through a small corneal incision.
- DeviceWaveFront Optimized LASIK
A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.
- DeviceTopography Guided LASIK
A form of LASIK where a corneal topography of the cornea is used to create the surgical profile for treating the cornea.
Location
- Hoopes Moshirfar Research CenterDraper, Utah