Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects

Inclusion Criteria

• Subjects aged 55 years or older.
• Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a lens power between 17.0 diopters and 24.0 diopters clearly evidenced by photographic documentation by one of the following:
• patient medical record
• clinic chart with labeling attached
• surgical record with labeling attached, or
• patient identification card with make, model and serial number.
• Subjects who have already had cataract surgery at least 6 months from the planned date of the IOPCL surgery.
• Subjects who have had a Nd: YAG capsulotomy at least 1 month prior to the planned date of the IOPCL surgery.
• Subjects with non-neovascular dry AMD meeting the following criteria:
• No change in Amsler Grid test within the past 12 months
• No subretinal fluid or macular hemorrhage confirmed by optical coherence tomography (OCT) imaging.
• No fundoscopic changes within the past 12 months (i.e., changes in retinal pigment epithelium).
• Subjects with best corrected distance visual acuity from 20/80 to 20/800.
• Subjects with a preoperative manifest refraction spherical equivalent (MRSE) of +1.0D to -1.0D.
• Subjects with ≤1.0D of corneal cylinder determined by keratometry readings.
• Subjects who are unsatisfied with their current near vision correction provided by either spectacles or external magnifier.
• Subjects who demonstrate at least 10 letters of near visual acuity improvement with the simulation/tolerance test (using manifest refraction with +7.0D add) compared to conventional near vision testing (using manifest refraction with +3.0D add).
• Subjects with a minimum endothelial cell count of 1800 cells/mm2.
• Subjects willing to abstain from pursuing any other surgical vision-correcting procedures for the duration of the study.
• Subjects who are willing and able to complete all required postoperative visits.
• Subjects who are able to comprehend and sign a statement of informed consent.

Exclusion Criteria

• Subjects who have already had cataract surgery with a toric or multifocal or accommodating Intraocular Lens.
• Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a power below 17.0 diopters and greater than 24.0 diopters.
• Subjects with neovascular (wet) AMD.
• Subjects who have not had an Nd: YAG capsulotomy.
• Subjects who were treated with an IOL off-label.
• Subjects who have more than 1.0D of corneal cylinder determined by Keratometry readings.
• Subjects whose continuous curvilinear capsulorhexis was less than 5mm or more than 6.0 mm in size at the time of IOL surgery.
• Subjects who had cataract surgery less than 6 months from the planned date of the IOPCL surgery.
• Subjects with anterior capsule fibrosis and phimosis that in the opinion of the investigator may confound the outcome or increase the risk to the subject.
• Subjects who do not gain at least 10 letters of near visual acuity with the simulation/tolerance testing (using manifest refraction with +7.0D add) compared to conventional near vision testing (using manifest refraction with +3.0D add).
• Subjects with a concomitant retinal or choroidal disorder other than AMD.
• Subjects with any corneal abnormality, other than regular corneal astigmatism that in the opinion of the investigator would confound the outcome(s) of the study.
• Subjects with clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy).
• Subjects with microphthalmos.
• Subjects with a previous retinal detachment.
• Subjects with a recurrent severe anterior or posterior segment inflammation of unknown etiology.
• Subjects with iris neovascularization.
• Subjects with glaucoma.
• Subjects with advanced visual field defects (e.g., central large scotoma where magnification would not help).
• Subjects with a fundus not visible.
• Subjects with aniridia.
• Subjects with