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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 50
Healthy Volunteers: t
View:

• 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.

• Surgical plan includes treatment target for emmetropia in both eyes, and no monovision.

⁃ Subject is capable and willing to use postoperative medications as prescribed.

⁃ Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits.

⁃ Subject is willing and able to return for all postoperative examinations.

Locations
United States
Utah
Hoopes Moshirfar Research Center
RECRUITING
Draper
Contact Information
Primary
Steven H Linn, OD
slinn@hoopesvision.com
801-988-7342
Backup
Shealynn Petersen, BS
sheapetersen@hoopesvision.com
801-988-7342
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2029-09
Participants
Target number of participants: 120
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Hoopes Vision

This content was sourced from clinicaltrials.gov