A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses

Prior treatment

• Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
• Subject with previous intraocular or corneal surgery
• Concurrent participation in another drug or device evaluation.

Other illness

• Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
• Subject with ocular condition that may predispose the subject to future complications
• Other condition associated with fluctuation of hormones

Other

• Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
• Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
• ACD measured from the endothelium lower than 2.8 mm
• Any cataract of any grade.
• Coefficient of variation of endothelial cell area \>0.45
• Percent Hexagonality of endothelial cell shape ≤ 45%
• Monocular subject
• Vulnerable subjects as defined in section 12.3.10

• 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