The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or elimination of myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or without astigmatism) and MRSE ≤ -11.50 D.
This is a prospective multi-center clinical trial in which a maximum of 360 eyes of 360 consecutive subjects will be enrolled and treated with the VisuMax™ Femtosecond Laser. The study will be conducted at up to 8 clinical sites. Subjects will be screened for eligibility, and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline ocular condition. Baseline and postoperative measurements will include manifest refraction, cycloplegic refraction, distance visual acuity (best corrected and uncorrected), slit-lamp examination, fundus examination, corneal topography, central corneal pachymetry, mesopic pupil measurement, wavefront analysis, mesopic contrast sensitivity, and intraocular pressure (IOP). Only eyes with astigmatism ≥ -0.75 D to ≤ -3.00 D targeted for the full distance manifest spherocylindrical refraction, or eye(s) with astigmatism \< -0.75 D targeted for the full distance manifest sphere-only refraction, will be enrolled into the study. Subjects must have astigmatism ≤ -3.00 D in the eye to be treated. Eyes with astigmatism ≥ -0.75 D to ≤ -3.00 D will receive a spherocylindrical treatment. Eyes with astigmatism \< -0.75 D will receive a sphere-only treatment. Operative eyes with astigmatism ≥ -0.75 D to ≤ -3.00 D must be targeted for the full distance manifest spherocylindrical refraction. Operative eye(s) with astigmatism \< -0.75 D must be targeted for the full distance manifest sphere-only refraction. Monovision treatments and retreatments of the study eye will not be allowed during the course of the study. Bilateral investigational treatments will not be allowed during the study. Safety and effectiveness criteria from the American National Standard for Ophthalmics (ANSI Z80.11-2012) - Laser Systems for Corneal Reshaping will be utilized in the evaluation of the VisuMax Femtosecond Laser.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
357
VisuMax femtosecond laser sphere-only or spherocylindrical treatment
Dishler Laser Institute
Greenwood Village, Colorado, United States
Discover Vision Centers
Leawood, Kansas, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Slade and Baker Vision Center
Houston, Texas, United States
Number of subjects with MRSE within ± 1.00 D and ± 0.50 D
Predictability: Decrease in manifest refraction spherical equivalent (MRSE) to within ± 1.00 D and ± 0.50 D of the intended refractive outcome at the point at which stability is first reached
Time frame: 1 Year
Improvement in UCVA following treatment
The uncorrected visual acuity of 20/40 or better for eyes targeted for emmetropia at the postoperative interval at which stability has been established
Time frame: 1 Year
Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)
Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA): 1. In eyes with preoperative BSCVA 20/20 or better, the percentage of eyes with BSCVA worse than 20/40 at the postoperative interval at which stability has been established 2. The percentage of eyes with BCVA loss ≥ 2 lines
Time frame: 1 Year
Number of subjects with induced MRCyl > 2.00 D
Induced manifest refractive astigmatism: The percentage of eyes treated for spherical myopia only with induced manifest refractive cylinder of \> 2.00 D at the postoperative interval at which stability has been established
Time frame: 1 Year
Incidence of Adverse Events
Incidence of Adverse Events: The rate of each type of adverse event will be summarized
Time frame: 1 Year
Change in Contrast Sensitivity
Contrast Sensitivity: Mean of "within-eye" loss of contrast sensitivity from baseline to 12 months will be provided with the 1-sided 95% confidence interval for each spatial frequency. Percentage of eyes showing ≥ 0.3 log units loss at two or more spatial frequencies at the last available postoperative visit will be calculated.
Time frame: 1 Year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Davis Duehr Dean
Madison, Wisconsin, United States
Patient Symptoms
Patient Symptoms: Will be considered as a secondary safety variable and will be evaluated via a subject questionnaire.
Time frame: 1 Year