Status:
RECRUITING
A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism
Lead Sponsor:
Hoopes Vision
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
22-50 years
Phase:
NA
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 Visuma...
Detailed Description
This is a prospective, randomized, simultaneous, contralateral eye study comparing visual outcomes for 4 different refractive technologies. This study will be conducted in 3 phases. Each phase will in...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Clinically significant dry eye on clinical examination, as determined by the investigator
- Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal tomography
- History of corneal dystrophies or guttata
- History of herpetic keratitis or active disease
- History of prior refractive surgery
- History of glaucoma or glaucoma suspect
- History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease.
- Females who are pregnant, breastfeeding, or intend to become pregnant any time during the study as determined by verbal inquiry.
- The Principal Investigator has determined the subject not to be a good candidate for the study.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07201298
Start Date
September 1 2025
End Date
September 1 2029
Last Update
October 1 2025
Active Locations (1)
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1
Hoopes Moshirfar Research Center
Draper, Utah, United States, 84020