Evaluation of Mesopic Visual Acuity and Patient Satisfaction Following Ray-Tracing-Guided LASIK
To provide comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
• Subjects ages 18 to 45 years old.
• Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery or stability as determined by the investigator.
• Myopia with or without astigmatism and MRSE within the range of indications for wavelight plus (myopia up to -8.00D, astigmatism up to -3.00D, S.E. more than -1.00 and up to -9.00D)
• Best corrected distance visual acuity (BCDVA) of 20/20 or better (≥83 letters) in each eye.
• Subjects who have elected to undergo bilateral LASIK targeted for emmetropia.
• Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
• Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
• Mesopic pupil size ≥4.5mm
• Less than 0.75D spherical equivalent differences between Sightmap measured refraction SE and the subjective manifest refraction (MRSE)
⁃ Subjects who regularly drive at night and expect to continue night driving throughout the duration of the study, as determined by investigator assessment