A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses to Compare Outcomes in Patients With Moderate to High Myopia and Astigmatism
Objective: To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. Secondary
Objectives: To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism.
• Patients 21 years old or older.
• Calculated IOL Power is within the range of the investigational IOLs
• Corneal Cylindrical error within the range defined in the clinical investigation plan
• Subject has monocular UCVA 0.5 LogMAR or worse
• Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
• Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following criteria:
‣ Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
⁃ Two refractions were performed at least 7 days apart.
• Subject, who is expected to have residual postoperative cylindrical refractive error of ≥1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.
• Expected dilated pupil size at least large enough to visualize the axis marking.
• Patients willing to attend all follow-up appointments
• Patients must sign and be given a copy of the written Informed Consent form