Clinical Evaluation of the Adaptilens Accommodating IOL

Inclusion criteria

• Adults who are at least 21 years of age or older and of legal age or capacity to consent.
• Scheduled to undergo primary intraocular lens implantation for the correction of aphakia following phacoemulsification extraction of a senile cataract.
• Clear intraocular media other than cataract.
• Potential visual acuity of 20/32 or better in both eyes after cataract removal and IOL implantation as determined by diagnostic testing or investigator's judgement.
• Preoperative corrected distance visual acuity (CDVA) worse than 20/40 either with or without a glare source present (e.g., Brightness Acuity Tester) or scheduled for cataract removal due to significant cataract-related symptoms/complaints.
• Calculated IOL power is within the range of the investigational IOL (+17.0 to +24.0 D).
• Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism.
• In good general health at screening as determined by the investigator.
• Signed written informed consent.
• Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and schedule.
• Operative Criteria -- For unilaterally implanted Adaptilens A-IOL Eyes: Completion of uncomplicated cataract surgery with implantation of the Control IOL and with no ongoing or persistent sight-threatening adverse events in the Control eye.

Exclusion criteria

• Planned secondary procedures (such as LASIK) during the term of the study; Nd YAG capsulotomy is permitted.
• Taking systemic medications that may confound the outcome or increase the risk to the subject.
• Ocular conditions that may predispose for future complications.
• Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject.
• Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes.
• Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future CDVA loss worse than 20/40.
• Any anterior segment pathology (anterior segment or corneal abnormalities, chronic uveitis, iritis, corneal dystrophy, pseudoexfoliation, etc.).
• Glaucoma, glaucoma suspect or ocular hypertension, i.e., IOP > 22 mmHg.
• Previous retinal detachment or retinal pathology, including age-related macular degeneration.
• Diabetes, currently being treated systemically and with retinopathy.
• Systemic or ocular disease that may prevent the patient from achieving CDVA of 20/32 or better post operatively.
• Require chronic administration of any topical ophthalmic or systemic medication that may affect accommodation such as mydriatic, cycloplegic and myotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, anticholinergic agents.
• CDVA of 20/32 or worse in the fellow eye not attributable to cataract.
• Current participation in, or have participated in, an investigational study, other than this study, within the previous 60 days before the operative day.
• Previous ocular surgery in the operative eye, including refractive surgery.