Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes

Inclusion Criteria

• Subjects must sign and be given a copy of the written Informed Consent form.
• Subjects must be emmetropes needing a magnitude of +1.00D to +2.50D of reading add.
• Subjects must have distance corrected near visual acuity worse than 20/40 and better than 20/100 in the eye to be implanted.
• Subjects 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 Plano to -0.75D with no more than 0.75D of refractive cylinder as determined by cycloplegic refraction in the eye to be implanted.
• Subjects must have a stable refraction twelve months prior to ACI implantation: i.e. MRSE within 0.50D over prior twelve months as determined by subject history.
• Subjects who are soft contact lens wearers must discontinue their contact lenses for at least one week prior to ACI pre-operative examination.
• Subjects must have a minimum central corneal thickness of ≥ 500 microns in the eye to be implanted.
• Subjects must have a corneal power of ≥ 41.00D and ≤ 47.00D in all meridians in the eye to be implanted.
• Subjects must be ≥ 45 years and ≤ 60 years of age at the time of subject eligibility visit.
• Subjects must have an endothelial cell count ≥ 2000 cells/mm2 in the eye to be implanted.
• Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.
• Subjects must demonstrate tolerance to monovision blur in the eye to be implanted as determined by loose lens blur tolerance or monovision contact lens trial.

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 abnormality (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be implanted.
• Subjects with ophthalmoscopic or topographic signs of keratoconus (or keratoconus suspect) or keratoectasia in the eye to be implanted.
• Subjects with dry eye as determined by objective testing; anesthetized Schirmer's test result 21 mmHg, glaucoma, ocular hypertension, or are glaucoma suspects.
• Subjects with an abnormal threshold visual field.
• Subjects with a history of diagnosed diabetes, diagnosed 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.