Comparing Ray‑Tracing Guided LASIK with three other laser vision correction methods for myopia and astigmatism
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.
This test will compare Ray‑Tracing Guided LASIK to three other laser or lenticule refractive procedures for adults with moderate myopia, with or without astigmatism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 22 Years to 50 Years |
| Sex | All |
| Sponsor | Hoopes Vision Academic / other |
| Locations | 1 site (Draper, Utah) |
| Trial ID | NCT07201298 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized contralateral‑eye comparison where each subject receives Ray‑Tracing Guided LASIK in one eye and a comparator procedure in the other eye. The trial is conducted in three phases, each enrolling at least 44 subjects to compare Ray‑Tracing LASIK with KLEx (Zeiss VisuMax), Wavefront‑Optimized LASIK (Alcon EX500), and Topography‑Guided LASIK (Contoura on Alcon EX500) respectively. Randomization determines which eye receives Ray‑Tracing LASIK, and subjects follow a standard postoperative schedule with visits at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months. Participants are recruited from Hoopes Vision patients and treated at the Hoopes Moshirfar Research Center in Draper, Utah.
Who should consider this trial
Good fit: Adults aged 22–50 with stable moderate myopia (manifest spherical equivalent −2.00 to −9.00 D), spherical component −2.00 to −8.00 D, ≤ −3.00 D cylinder, and 20/20 or better best‑corrected visual acuity are ideal candidates.
Not a fit: People with refractive error outside the specified ranges, unstable refractions, high astigmatism, or who cannot attend the Draper, Utah site visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could yield more accurate uncorrected vision and fewer visual symptoms after laser refractive correction.
How similar studies have performed: Wavefront‑optimized LASIK, topography‑guided LASIK (Contoura), and KLEx/SMILE have well‑published positive outcomes, while ray‑tracing guided LASIK is a newer technique with limited comparative data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 refraction to a previous refraction, spectacle Rx, or contact lens Rx, 12 months or older. 7. 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. 8. Acceptable preoperative tomography and examination results for refractive procedures as determined by the Principal Investigator. 9. Surgical plan includes treatment target for emmetropia in both eyes, and no monovision. 10. Subject is capable and willing to use postoperative medications as prescribed. 11. Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits. 12. Subject is willing and able to return for all postoperative examinations. Exclusion Criteria: 1. Clinically significant dry eye on clinical examination, as determined by the investigator 2. Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal tomography 3. History of corneal dystrophies or guttata 4. History of herpetic keratitis or active disease 5. History of prior refractive surgery 6. History of glaucoma or glaucoma suspect 7. History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease. 8. Females who are pregnant, breastfeeding, or intend to become pregnant any time during the study as determined by verbal inquiry. 9. The Principal Investigator has determined the subject not to be a good candidate for the study.
Where this trial is running
Draper, Utah
- Hoopes Moshirfar Research Center — Draper, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Majid Moshirfar, MD — Hoopes Vision
- Study coordinator: Steven H Linn, OD
- Email: slinn@hoopesvision.com
- Phone: 801-988-7342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.