Using the VisuMax Femtosecond Laser System to Perform SMILE Optimized for Presbyopia by Modulation of Postoperative Spherical Aberration
Myopia, Myopic Astigmatism, Presbyopia
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria: Fulfillment of the general inclusion criteria stated in User Manual of the VisuMax option SMILE Presence 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 older Presence of presbyopia Patients 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 vision Pre-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 worse Target refraction of the near eye between -0.50 D to -1.75 D Acceptance 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 examinations Exclusion 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 surgery Hyperopic refraction Mixed astigmatism refraction Emmetropic eyes, defined as spherical equivalent refraction <-0.88 D, maximum hyperopia ≤+1.00 D and cylinder <1.25 D Patients presenting any kind of amblyopia Previous intraocular or corneal surgery Participation in other ophthalmologic or pharmaceutical studies Women during pregnancy and/or lactation Patients whose freedom is impaired by administrative or legal order Persons incapable of giving consent
Sites / Locations
- London Vision Clinic
Arms of the Study
Arm 1
Other
HiSMILE treatment option
HiSMILE treatment option