Clinical Evaluation of the Adaptilens Accommodating IOL

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.