To provide comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
50
comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
Vance Thompson Vision
Sioux Falls, South Dakota, United States
RECRUITINGEstablish non-inferiority of the post-operative uncorrected mesopic distance visual acuity MVA (UC-MVA, monocular) at 6 months to the pre-operative Best Spectacle-Corrected MVA (BSC-MVA, monocular), assessed in logMAR units
Time frame: Baseline compared to 6 month post operative visit
Patient reported outcome of overall satisfaction with vision, measured using the Patient Reported Outcomes with LASIK - Satisfaction Survey (#1 of PROWL-SS, 0-100)
Time frame: Baseline compared to 6 month post operative visit
Satisfaction with night vision (modified based on #1 of PROWL-SS, 0 - 100) at baseline and 6-month post-op
Time frame: Baseline compared to 6 month post operative visit
Difficulty driving at night (from PROWL, Top-2-box) at baseline and 6-month post-op
Time frame: Baseline compared to 6 month post operative visit
Frequency of starbursts or halo that bother you (PROWL, Top-2-box) at baseline and 6-month post-op
Time frame: Baseline compared to 6 month post operative visit
Mesopic contrast sensitivity measured with and without glare (binocular) at baseline and 6-month post-op+
Time frame: Baseline compared to 6 month post operative visit
Uncorrected Distance Visual Acuity under photopic conditions at 6-month post-op
Time frame: Baseline compared to 6 month post operative visit
Refractive predictability, percentage of eyes within ±0.25D, ±0.50D of target MRSE at 6-month post-op
Time frame: Baseline compared to 6 month post operative visit
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