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.
This is a prospective, randomized, simultaneous, contralateral eye study including at least 42 patients undergoing refractive correction surgery. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. Randomization will ensure 50% of Right Eyes will receive Topography-Guided LASIK and 50% of Right Eyes will receive Small Incision Lenticule Extraction. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
LASIK surgery, using corneal topography data in treatment profile, to correct myopia or myopia with astigmatism refractive error.
Corneal lenticule formation using a femtosecond laser, with subsequent lenticule extraction, to correct myopia or myopia with astigmatism refractive error.
Hoopes Vision
Draper, Utah, United States
Uncorrected Visual Acuity
Percentage of eyes with Uncorrected Visual Acuity of 20/20 or better
Time frame: 12 months
Corrected Visual Acuity
Percentage of eyes with Corrected Visual Acuity of 20/20 or better
Time frame: 12 months
Predictability of Intended Outcome
Percentage of eyes with refractive error within +/- 0.50 D MRSE and +/- 1.00 D MRSE of intended correction
Time frame: 12 months
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