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Compares treatment options for Myopia
Official title A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism
ClinicalTrials.gov ID: NCT07201298
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 50. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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)
- people 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...
- people 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Draper, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Draper, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.