Safety and Effectiveness Study of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes

Inclusion Criteria

• Subjects must be natural emmetropes needing a minimum magnitude of +1.00D to +2.50D of reading add.
• Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/100 in the eye to be implanted.
• Subject must have distance visual acuity correctable to at least 20/20 in both eyes.
• Subjects must have a preoperative spherical equivalent of plano defined as +0.50D to -0.75D with no more than 0.75D of refractive cylinder as determined by cycloplegic refraction in the eye to be implanted.

Exclusion Criteria

• Subjects with a difference of > 1.00D between the spherical equivalent manifest refraction and the spherical equivalent cycloplegic refraction.
• Subjects with anterior segment pathology, including cataracts, in the eye to be implanted.
• Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be implanted.
• Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be implanted.
• Subjects with a history of chronic dry eye not responding to therapy.
• Subjects with distorted or unclear corneal mires on topography maps of the eye to be implanted.
• Subjects who require canthotomy to generate a corneal flap in the eye to be implanted.
• Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in the eye to be implanted.
• Subjects who have undergone previous intraocular or corneal surgery including cataract and LASIK surgery.
• Subjects with a history of herpes zoster or herpes simplex keratitis.
• Subjects who have a history of steroid-responsive rise in intraocular pressure, preoperative IOP > 21 mmHg, glaucoma, or is a glaucoma suspect.
• Subjects with a history of diagnosed diabetes, autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
• Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects.
• Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology including ocular allergy.
• Subjects using systemic medications with significant ocular side effects.
• Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
• Subjects with known sensitivity to planned study concomitant medications.
• Subjects who are participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.