A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism

Part of paid clinical trials in Draper, Utah.

Sponsor
Hoopes Vision
Study ID
NCT07201298
Status
Recruiting
Apply to this trial

Conditions

  • Astigmatism
  • Myopia

Eligibility Criteria

Sex
ALL
Age
22 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Ray-Tracing Guided LASIK — DEVICE
    A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
  • Keratorefractive Lenticule Extraction (KLEx) — DEVICE
    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.
  • WaveFront Optimized LASIK — DEVICE
    A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.
  • Topography Guided LASIK — DEVICE
    A form of LASIK where a corneal topography of the cornea is used to create the surgical profile for treating the cornea.

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ARM 1: Ray Tracing Guided LASIK in OD and Keratorefractive Lenticule Extraction in OS
    Subjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Keratorefractive Lenticule Extraction in the LEFT EYE
  • Active Comparator: ARM 2: WaveLight Plus LASIK in OS and Keratorefractive Lenticule Extraction in OD
    Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Keratorefractive Lenticule Extraction in the RIGHT EYE
  • Active Comparator: ARM 3: Ray Tracing Guided LASIK in OD and Wavefront Optimized LASIK in OS
    Subjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Wavefront Optimized LASIK in the LEFT EYE.
  • Active Comparator: ARM 4: Ray Tracing Guided LASIK in OS and Wavefront Optimized LASIK in OD
    Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Wavefront Optimized LASIK in the RIGHT EYE
  • Active Comparator: ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OS
    Subjects receive Ray Tracing Guided in the RIGHT EYE and Topography Guided LASIK in the LEFT EYE
  • Active Comparator: ARM 6: Ray Tracing Guided LASIK in OS and Topography Guided LASIK in OD
    Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Topography Guided LASIK in the RIGHT EYE

Primary Outcome Measure

Uncorrected Visual Acuity [ Time Frame: 3, 6 and 12 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hoopes Moshirfar Research CenterDraperUtah84020
Steven H Linn, OD
[email protected]
801-988-7342
Shealynn Petersen, BS
[email protected]
801-988-7342
Majid Moshirfar, MD (PRINCIPAL_INVESTIGATOR)

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Hoopes Moshirfar Research Center· Draper, UT

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