The Use of the VisuMaxTM Femtosecond Laser Small-Incision Lenticule Extraction (SMILE) Procedure for the Correction of Myopia with or without Astigmatism study is a prospective, non-randomized, multicenter clinical study that will be conducted by the Navy Refractive Surgery Center, Naval Medical Center San Diego, CA in collaboration with the U.S. Air Force 59th Medical Wing, Wilford Hall Eye Center, TX, and the U.S. Army Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, VA.
Prospective, multicenter, open-label, non-randomized clinical trial with bilateral commercial treatment for FDA approved indications and unilateral treatments for investigational refractive errors. Data from each treated eye of subjects will be treated independently. Monovision treatments and retreatments of the study eye will not be allowed during the course of the study. Successful bilateral treatment is required for performance based testing and patient reported outcome testing. Subjects will be randomized into the 0.25 and 0.50 sphere only and spherical cylinder bins using a sequential alternating randomization with an equal number assigned to both bins. Other subjects will be assigned to the bins they qualify for as they are enrolled into the study. Appointments are given to patients requesting refractive surgery randomly. Three military sites in the U.S.A.: Navy Refractive Surgery Center, Naval Medical Center San Diego, CA in collaboration with the U.S. Air Force 59th Medical Wing, Wilford Hall Eye Center, TX, and the U.S. Army Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, VA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
treatment of low cylinder (\<0.75D)
Navy Warfighter Refractive Surgery Center
San Diego, California, United States
RECRUITINGMeasured postoperative refractive sphere and cylinder
manifest refraction spherical equivalent and manifest refractive cylinder refraction
Time frame: 12 months
Measured distance visual acuity
uncorrected visual acuity of 20/40 or better
Time frame: 12 months
Measured difference in manifest refraction between 2 postoperative visits
95% of eyes \<1.00D of MRSE change at latter of 2 postop refractions
Time frame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
Calculated rate of change in manifest refraction
mean rate of change of MRSE \<0.5D/year (0.04D/mo)
Time frame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
Calculated decreased rate of change in manifest refraction
mean rate of change of MRSE decreases monotonically over time
Time frame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
Calculated stable rate of change in manifest refraction
95% CI for the mean rate of change includes zero
Time frame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
Measured best corrected visual acuity (method 1)
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incidence of best spectacled correction worse than 20/40
Time frame: 12 months
Measured best corrected visual acuity (method 2)
incidence of loss of \>2 lines of best spectacled corrected visual acuity
Time frame: 12 months
Measured refractive cylinder
incidence of induced cylinder \>2D
Time frame: 12 months
Incidence of adverse events
incidence of adverse events
Time frame: 12 months
Incidence of patient reported visual phenomena
incidence of patient subjective symptoms
Time frame: 12 months
Measured contrast sensitivity
change in contrast sensitivity from preop to postop
Time frame: 12 months