Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration

Exclusion Criteria

• •1. Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
• •2. Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
• •3. A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP\>22 mm Hg.
• •4. Corneal guttata.
• •5. Known sensitivity to post-operative medications.
• •6. Significant communication impairment or severe neurological disorders.
• •7. Have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes.
• •8. An ocular condition that predisposes the patient to eye rubbing.
• •9. Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery.
• •10. Patients for whom the planned operative eye has:
• •* Myopia \> 6.0 D
• •* Hyperopia \> 4.0 D
• •* Axial length \< 21 mm
• •* Endothelial cell density \< 1600 cells per square mm
• •* Narrow angle, i.e., \< Schaffer grade 2.
• •11. Inflammatory ocular disease.
• •12. Cornea stromal or endothelial dystrophies, including guttata.
• •13. Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
• •14. Diabetic retinopathy.
• •15. Untreated retinal tears.
• •16. Retinal vascular disease.
• •17. Optic nerve disease.
• •18. A history of retinal detachment.
• •19. Retinitis pigmentosa.
• •20. Intraocular tumor.
• •21. Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study.
• •22. Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.
• •23. Have a condition or be in a situation that, in the Investigator's opinion, may put the Subject at significant risk, may confound the study results, or may interfere significantly with the Subject's participation in the study.