Clinical Trial With Artiflex Presbyopic (Artiplus)

Inclusion Criteria:

• Presbyopic adult

• Potential for binocular vision

• Subject wishes to be spectacle independent for near and far vision

• Refractive error that can be corrected with correction at PIOL plane from +2.0 to -15.0 D

• Subject requiring a presbyopic correction Patients with reading glasses of minimum +1D.

• Stable refraction (±0.75 D), as expressed by manifest refraction sphericalequivalent (MRSE) for a minimum of 12 months prior to surgery, verified byconsecutive refractions and/or medical records or prescription history

• Expected best corrected visual acuity of 0.2 logMAR (0.63 Snellen decimal) or betterafter lens implantation

• Current contact lens wearer should demonstrate a stable refraction (± 0.5 D),expressed as subjective refraction spherical equivalent, on two consecutiveexamination dates performed at least 7 days apart. Before the first refraction, thecontact lens wearer should not have worn lenses for at least 2 weeks in case ofrigid and toric contact lenses, or 3 days for spherical soft contact lenses.

• Any subject, who is expected to have a residual postoperative cylindrical refractiveerror of below 0.75 D

• Ability to give informed consent

• Availability, willingness and sufficient cognitive awareness and physical ability tocomply with examination procedures throughout the entire duration of the study

Exclusion Criteria:

Pre-existing pathology or physiology which may be aggravated by the implant or where the implant may interfere with the possibility of examining or treating disease:

• Preoperative ocular or systemic condition or medication use that would be expectedto present undue risk to the subject, that can predispose for future complicationsor confound the outcome(s) of the study. E.g. the systemic use of alpha-1aadrenergic receptor antagonists was suggested to increase the occurrence ofintraoperative floppy iris syndrome, alter iris morphology - or more specificallyreduce iris thickness at the site of potential IOL enclavation - and increasepostoperative endothelial cell loss.

• Previous ocular surgery which might affect the outcome of the study

• Concurrent participation or participation during the last 30 days in another drug ordevice investigation

• Secondary surgical procedure planned during the first 6 months of the study (e.g.laser treatment to correct astigmatism)

• Amblyopia

• Preoperative anterior chamber depth measurement of below 3.0 mm for subjects < 40years old and 2.8 mm for subjects > 40 years old. Anterior chamber depth is beingmeasured from corneal endothelium to the anterior pole of the crystalline lens. Thiswill result in a critical distance between PIOL and endothelium of 1.5 mm or more assimulated with anterior segment imaging.

• White-to-white smaller than 10.5 mm

• Subjects not meeting the age specific minimum preoperative endothelial cell densityas defined below:

31 to 35 years of age 2400 cells/mm2; 36 to 45 years of age 2200 cells/mm2; > 45years of age 2000 cells/mm2

• Corneas with high rates of polymegethism (a coefficient of variation over 0.40) andpleomorphism (the presence of less than 50% hexagonal cells).

• Abnormal iris (e.g. convex, bulging or volcano shaped iris)

• Crystalline lens rise of 600 µm or more

• Abnormal cornea (keratoconus, opaque cornea, corneal scars, post corneal transplant,corneal dystrophy, or other)

• Ocular surface conditions which might influence the quality of vision and affect theoutcome of the study

• Abnormal pupil (e.g. nonreactive, fixed)

• Ectopic pupil

• Pupil in photopic light conditions smaller than 2.6 mm

• Pupil in scotopic light conditions greater than 7.0 mm

• High preoperative intraocular pressure (>21 mm Hg)

• Cataract of any grade

• Glaucoma or family history of glaucoma (dependent on the evaluation of physician)

• Diabetes or diabetic retinopathy

• Acute or chronic inflammation

• Chronic or recurrent uveitis or family history of the same condition

• Retinal detachments or family history of retinal detachments

• Corticosteroid responder

• Pregnant or nursing

• Unstable refraction (≥ 0.5D of variability in refraction over the last 12 months)

• Aged under 18