A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive … (NCT07201298) | Clinical Trial Compass
RecruitingNot Applicable
A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism
United States120 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range22 Years – 50 Years
SexALL
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Inclusion criteria
✓. Age 22-50 at the time of consent
✓. 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)
✓. Preop Spherical component of ≥ -2.00 and ≤ -8.00 D (-2.00 D through -8.00 D)
✓. Refractive Cylinder of ≤ -3.00 D (0.00 through -3.00 D)
✓. BCVA of 20/20 or better in each eye (83 or more letters on the ETDRS Chart)
✓. 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 refraction to a previous refraction, spectacle Rx, or contact lens Rx, 12 months or older.
✓. Subjects who are contact lens wearers must discontinue the use of soft lenses (spherical or toric) for at least 5 days and hard or gas-permeable lenses for at least 4 weeks prior to the preoperative screening evaluation. Hard or gas-permeable lens wearers must not return to contact lens use before surgery. Soft lens wearers may resume contact lens wear after all preoperative testing is completed, but must discontinue lens use at least 5 days before surgery.
✓. Acceptable preoperative tomography and examination results for refractive procedures as determined by the Principal Investigator.
Exclusion criteria
✕. Clinically significant dry eye on clinical examination, as determined by the investigator
✕. Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal tomography