Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction (NCT05611294) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction
United States42 participantsStarted 2022-09-27
Plain-language summary
This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye.
Who can participate
Age range22 Years – 50 Years
SexALL
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Inclusion criteria
✓. Age 22-50 at the time of consent
✓. Diagnosis of myopia or myopia with astigmatism with Preop manifest spherical equivalent of refraction of ≥ -2.00 and ≤ -9.00 D
✓. Preop Spherical component of ≥ -2.00 and ≤ -8.00 D
✓. Refractive Cylinder of ≤ -3.00 D
✓. BCVA of 20/20 or better in each eye
✓. Subjects must have a stable refraction which is defined as change in spherical equivalent no greater than 0.50 D comparing screening visit manifest refraction to previous refractions over one year period prior to surgery. (spectacle Rx, or contact lens Rx)
✓. Subjects who are contact lens wearers must have hard or gas permeable lenses discontinued for at least 4 weeks and soft lenses discontinued for at least 5 days prior to the preoperative screening evaluation. Hard or gas permeable lens wearers must not return to contact lens use before surgery and soft lens wearers must discontinue use at least 5 days before surgery.
✓. Acceptable topography and baseline examination results for refractive procedures as determined by Principal Investigator or Co-Investigator
Exclusion criteria
✕. Clinically significant dry eye on clinical examination as determined by the investigator
✕. Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal topography