A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near and Intermediate Vision in Pseudophakic Presbyopic Subjects

Inclusion Criteria

• •1. Subjects must provide informed consent, have signed the written informed consent form, and been given a copy.
• •2. Subjects must be bilateral pseudophakic adults with presbyopia, needing reading add from +1.50 D to +2.50 D.
• •3. Subjects must be at least 50 years old
• •4. Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/200 in the non-dominant eye.
• •5. Subjects must have monocular uncorrected distance visual acuity of 20/25 or better in both eyes.
• •6. Subjects must have distance and near visual acuity correctable to at least 20/20 in both eyes.
• •7. Subjects must have a manifest refraction spherical equivalent (MRSE) between -0.50 and +1.00 D with no more than 0.75 D of refractive cylinder in the non-dominant eye.
• •8. Subjects must have a tear break-up time (TBUT) of ≥8 seconds.
• •9. Subjects must have a central corneal thickness of between 480 and 600 microns in the non-dominant eye.
• •10. Subjects must have an average corneal power of ≥ 41.00 D and ≤ 47.00 D in the non-dominant eye.
• •11. Subjects must have a photopic pupil size of ≥3.0 mm, in the non-dominant eye.
• •12. Subjects must have an endothelial cell count ≥ 2200 cells/mm2 in the eye to be implanted (non-dominant).
• •13. Subjects who are contact lens wearers must discontinue hard or rigid gas permeable lenses for at least 3 weeks and discontinue soft lenses for at least 1 week prior to baseline examination.
• •14. Subjects who are contact lens wearers must have two (2) central keratometry readings with regular mires and two (2) manifest refractions taken at least one week apart, with no contact lens wear between. Keratometric values must not differ by more than ± 0.50 D in any meridian the eye to be implanted. MRSE values must not differ more than ±0.50 D in the non-dominant eye.
• •15. Subjects must have documented monovision tolerance as determined by a 5-day contact lens trial prior to surgery.
• •16. Subjects must have a minimum of 3 months between cataract surgery and implantation of the Raindrop Near Vision Inlay in the non-dominant eye.
• •17. Subjects must be able to demonstrate refractive stability after cataract surgery (e.g., No change in MRSE greater than ± 0.50 D within the last 2 consecutive visual examinations after IOL implantation, performed at least 3 months apart.
• •18. Subjects must have a clear or open posterior capsule in the non-dominant eye.
• •19. Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.