Using the VisuMax Femtosecond Laser System to Perform SMILE Optimized for Presbyopia by Modulation of Postoperative Spherical Aberration

The intended purpose of the investigational device in the study is the correction of myopia and myopia with astigmatism in the CE (Conformité Européene) approved range and optimized for presbyopic patients using the treatment option HiSMILE, installed on the VisuMax femtosecond laser.

Inclusion Criteria:Fulfillment of the general inclusion criteria stated in User Manual of the VisuMax option SMILEPresence of myopia up to -10.00 D with or without astigmatism up to 5.00 D and a maximum spherical equivalent of -12.50 D (SMILE CE approved range)Age of 40 years or olderPresence of presbyopiaPatients able to receive a refractive correction in both eyes and in addition a compensation of presbyopia, in which one eye should be targeted for far vision and one eye should be targeted for near visionPre-operative CDVA of 20/25 or better in each eye as well as a Distance Corrected Near Visual Acuity (DCNVA) of 20/25 (J2) or worseTarget refraction of the near eye between -0.50 D to -1.75 DAcceptance of anisometropia (no visual discomfort or disturbances during the Acceptance Test before surgery, eye intended for near vision determined during this test)Compliance with follow-up visits and examinationsExclusion Criteria:Presence of at least one of the contraindications stated in the User Manual of the VisuMax option SMILE or in the Surgical Information Package provided to the patient by the London Vision Clinic before surgeryHyperopic refractionMixed astigmatism refractionEmmetropic eyes, defined as spherical equivalent refraction <-0.88 D, maximum hyperopia ≤+1.00 D and cylinder <1.25 DPatients presenting any kind of amblyopiaPrevious intraocular or corneal surgeryParticipation in other ophthalmologic or pharmaceutical studiesWomen during pregnancy and/or lactationPatients whose freedom is impaired by administrative or legal orderPersons incapable of giving consent