Phase
Condition
Astigmatism
Myopia
Treatment
Topography Guided LASIK Surgery
Small Incision Lenticule Extraction Surgery
Clinical Study ID
Ages 22-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 22-50 at the time of consent
Diagnosis of myopia or myopia with astigmatism with Preop manifest sphericalequivalent 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 sphericalequivalent no greater than 0.50 D comparing screening visit manifest refraction toprevious refractions over one year period prior to surgery. (spectacle Rx, orcontact lens Rx)
Subjects who are contact lens wearers must have hard or gas permeable lensesdiscontinued for at least 4 weeks and soft lenses discontinued for at least 5 daysprior to the preoperative screening evaluation. Hard or gas permeable lens wearersmust not return to contact lens use before surgery and soft lens wearers mustdiscontinue use at least 5 days before surgery.
Acceptable topography and baseline examination results for refractive procedures asdetermined by Principal Investigator or Co-Investigator
Surgical plan includes treatment target for emmetropia in both eyes and nomonovision.
Subject is capable and willing to use postoperative medications as prescribed.
Subject has ability to successfully complete all preoperative and postoperativequestionnaires, testing, and exam visits.
Subjects are willing and able to return for all postoperative examinations.
Exclusion
Exclusion Criteria:
Clinically significant dry eye on clinical examination as determined by theinvestigator
Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal cornealtopography
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 autoimmunedisease.
Females who are pregnant, breast-feeding, or intend to become pregnant any timeduring the course of the study as determined by verbal inquiry.
The Principal Investigator has determined the subject not to be a good candidate forthe study
Study Design
Study Description
Connect with a study center
Hoopes Vision
Draper, Utah 84020
United StatesSite Not Available
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