Clinical Performance of a Phakic Intraocular Lens (IOL)

Inclusion Criteria

• •1. Must be able to read, understand and provide written informed consent,
• •2. Willing and able to comply with all treatment and follow-up study related procedures,
• •3. 40 - 60 years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D,
• •4. 35 - 45 years of age at time of surgery if require a spherical lens power from 0.0 D to +3.00 D,
• •5. Preoperative refraction fully correctable with available lens powers, with ≤ 0.75 D preoperative refractive and residual cylinder,
• •6. \< 0.75 D spherical equivalent difference between cycloplegic and manifest refractions,
• •7. Stable correction (± 0.50 D) as determined by manifest refraction spherical equivalent (MRSE),
• •8. Best Corrected Distance Visual Acuity 20/20 or better in both eyes,
• •9. Requires +1.00 D to +2.50 D reading add,
• •10. Anterior chamber depth (ACD) ≥ 2.8 mm if require spherical lens powers from -0.50 D to -18.00 D,
• •11. ACD ≥ 3.0 mm if require spherical lens powers from 0.00 D to +3.00 D,
• •12. Anterior chamber angle ≥ Grade III,
• •13. Phakic in both eyes,
• •14. Current contact lens wearers need to demonstrate a stable refraction, (± 0.5 D), expressed as MRSE, on two consecutive examination dates with refractive stability determined by the following criteria:
• •1. contact lenses were not worn for at least 2 weeks (rigid and toric contact lenses) or 3 days (soft contact lenses) prior to the first refraction,
• •2. two refractions were performed at least 7 days apart.