Prospective Multicenter Clinical Study on the Visual and Refractive Outcomes and Safety Outcomes Following Implantation of an AddOn Intraocular Lens in Previously Pseudophakic Eyes

Exclusion Criteria

• •1. Currently pregnant or lactating.
• •2. Prisoners or young offenders in custody
• •3. Adults lacking capacity to consent for themselves
• •4. Phakic or aphakic status.
• •5. Narrow angle, i.e. \< Schaefer grade 2
• •6. Pseudophakic patients with malpositioned, subluxated or unstable capsular fixated intraocular lens.
• •7. Patients with a multifocal capsular bag fixated IOL.
• •8. Inability to achieve secure placement in the designated location e.g. due to absence of a secure peripheral anterior capsule, absence of intact zonules, or irregular anatomy of the ciliary sulcus.
• •9. Active ocular diseases (chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication, iris atrophy, severe zonulopathy, pigment dispersion syndrome).
• •10. Corneal abnormalities such as Unstable Keratoconus, irregular astigmatism.
• •11. Existing ocular conditions such as age-related macular degeneration (AMD) and other progressive retinal degenerations.
• •12. Any previous ocular co-morbidity including pseudoexfoliation, zonular weakness, pseudophakodonesis, complicated cataract surgery, narrow angle glaucoma or macular pathology, congenital eye abnormality, microphthalmia.
• •13. Any eye disease in which postoperative visual acuity is not expected to be better than 0.5 decimal (e.g. amblyopia, nystagmus, retinitis pigmentosa, aniridia, eccentric pupil)
• •14. Subjects with pathological pupil reactions.
• •15. Subjects with untreated posterior capsule opacification (PCO), which results in at least 1-line decrease in visual acuity and/or in loss of contrast sensitivity (CS).
• •16. Any systemic disease (e.g., Sjögren's syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with visual function and/or participation in the study.
• •17. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with visual function.
• •18. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with visual function and/or participation in the study.
• •19. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
• •20. Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection, corneal decompensation) or any other ocular abnormality that may contraindicate the implantation of the supplementary IOL.
• •21. Any history or signs of a corneal inflammatory event, or any other ocular abnormality
• •22. Participation in any intraocular lens, contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• •23. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician)