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Recruiting NCT05611294

Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction

Conditions: Myopia, Astigmatism

Sex: All
Ages: 22 Years – 50 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 42
Sponsor: Hoopes Vision

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Age 22-50 at the time of consentDiagnosis of myopia or myopia with astigmatism with Preop manifest spherical equivalent of refraction of ≥ -2.00 and ≤ -9.00 DPreop Spherical component of ≥ -2.00 and ≤ -8.00 DRefractive Cylinder of ≤ -3.00 DBCVA of 20/20 or better in each eyeSubjects 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-InvestigatorSurgical 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.Subjects are willing and able to return for all postoperative examinations.Exclusion Criteria:Clinically significant dry eye on clinical examination as determined by the investigatorIrregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal topographyHistory of corneal dystrophies or guttataHistory of herpetic keratitis or active diseaseHistory of prior refractive surgeryHistory of glaucoma or glaucoma suspectHistory of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease.Females who are pregnant, breast-feeding, or intend to become pregnant any time during the course of the study as determined by verbal inquiry.The Principal Investigator has determined the subject not to be a good candidate for the study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05611294). StuddyBuddy aggregates publicly available trial information.