NCT07201298 A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism
| NCT ID | NCT07201298 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hoopes Vision |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-09 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-09 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Majid Moshirfar, MD
PRINCIPAL INVESTIGATOR
Hoopes Vision
Frequently Asked Questions
Who can join the NCT07201298 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 50 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07201298 currently recruiting?
Yes, NCT07201298 is actively recruiting participants. Contact the research team at slinn@hoopesvision.com for enrollment information.
Where is the NCT07201298 trial being conducted?
This trial is being conducted at Draper, United States.
Who is sponsoring the NCT07201298 clinical trial?
NCT07201298 is sponsored by Hoopes Vision. The principal investigator is Majid Moshirfar, MD at Hoopes Vision. The trial plans to enroll 120 participants.