Proof-of-concept Study for a New Intraocular Lens, MODEL C0001

Exclusion Criteria

• •Requiring an intraocular lens power needed to achieve emmetropia (spherical equivalent ± 0.50 D) outside the available range of +18.0 D to +30.0 D for the Model C0001 IOL or +16.0 D to +28.0 D for the Model ZCB00 IOL;
• •Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils);
• •Irregular corneal astigmatism;
• •Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
• •Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery;
• •Subjects who may be expected to require retinal laser treatment during the study;
• •Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;
• •Inability to achieve keratometric corneal stability preoperatively as a result of recent contact lens usage;
• •Subjects with diagnosed degenerative visual disorders (e.g., retinal disorders such as macular degeneration) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;
• •Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects;
• •Use of systemic or ocular medications that may affect vision;
• •Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);
• •Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
• •Poorly-controlled diabetes;
• •Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.); NOTE: Controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
• •Neurological or neurodegenerative disorders that affect locomotion and cognitive function (e.g., Muscular disorders, Parkinson's disease, Alzheimer's disease etc.);
• •Use of mobility aids;
• •Motion Sickness Susceptibility Questionnaire Short-form (MSSQ-Short) score of ≥ 25;
• •Subject has condition(s) associated with the fluctuation of hormones that could lead to refractive changes;
• •Concurrent participation in any other clinical trial or participation within 30 days prior to the preoperative visit.