Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD

Inclusion Criteria:

1. Be at least 65 years of age at the Pre-operative Visit;

2. Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visitcaused by bilateral central scotomas associated with end-stage AMD;

3. Have bilateral retinal findings of geographic atrophy or disciform scar with fovealinvolvement, as determined by standard of care fluorescein angiography (FA) prior tothe Pre-operative Visit;

4. Have been monitored by an eye care professional over the 6-month (or longer) periodimmediately prior to the Pre-operative Visit and have demonstrated no evidence ofactive choroidal neovascularization (CNV) prior to the Pre-operative Visit asdemonstrated by the following:

5. lack of need of treatment for CNV over the past 6 months, and

6. lack of active exudative fluid on optical coherence tomography (OCT) over thepast 6 months, and

7. lack of Retinal hemorrhage on exam over a 6-month period or longer

8. Agree to participate in post-operative visual training For the Implanted Eye:

9. Have evidence of visually significant cataract at the Pre-operative Visit;

10. Agree to undergo pre-operative training and assessment (1 or more sessions) with lowvision specialists (optometrist or occupational therapist) in the use of an externaltelescope model sufficient for patient assessment and patient must achieve at leasta 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment For the Non-Implanted Eye:

11. Have adequate peripheral vision at the Pre-operative Visit to allow navigation

Exclusion Criteria:

1. Have cognitive impairment that would interfere with the ability to understand andprovide Informed Consent or prevent proper visual training/rehabilitation with thedevice;

2. Have any of the following conditions at the Pre-operative Visit:

3. Stargardt macular dystrophy;

4. Diabetic retinopathy;

5. Untreated retinal tears;

6. Retinal vascular disease;

7. Optic nerve disease;

8. History of retinal detachment;

9. Intraocular tumor;

10. Retinitis pigmentosa;

11. History of steroid-induced rise in intraocular pressure (IOP), uncontrolledglaucoma, or IOP >22 mmHg at the Pre-operative Visit;

12. Have known allergy to post-operative medications;

13. History of eye rubbing or an ocular condition that predisposes subject to eyerubbing;

14. Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit;

15. Have any circumstance that, based on the Investigator's judgment, poses a concernfor the subject's safety;

16. Any systemic disease or clinical evidence of any condition at the Pre-operativeVisit which would make the subject in the opinion of the investigator unsuitable forthe study;

17. Concurrent participation or prior participation in any investigative drug or devicestudy within last 30 days prior to Pre-operative Visit For the Implanted Eye:

18. Have central anterior chamber depth (ACD) <3.0 mm from the posterior surface of thecornea (endothelium) to the anterior surface of the crystalline lens at thePre-operative Visit;

19. Have an Endothelial Cell Density (ECD) below:

20. 2,000 cells per millimeter, if 65-84 years old;

21. 1,800 cells per millimeter, if 85 years old or greater (based on the lowestvalue of the three cell counts performed by technician at investigative site atthe Pre-operative Visit)

22. Have a history of corneal stromal or endothelial dystrophies, including guttata;

23. Have Myopia > 6.0 D or Hyperopia > 4.0 D by Manifest Refraction at the Pre-operativeVisit;

24. Have an Axial Length (AL) < 21 mm at the Pre-operative Visit;

25. Have a narrow angle defined as < grade 2 on the Schaffer scale at the Pre-operativeVisit;

26. Ongoing Inflammatory ocular disease at the Pre-operative Visit;

27. Zonular weakness/instability of crystalline lens, or pseudoexfoliation at thePre-operative Visit;

28. Have any condition at the Pre-operative Visit which in the judgement of theInvestigator indicates that the haptics cannot be placed within the capsular bagduring surgery;

29. Have had previous intraocular or corneal surgery, including any type of surgery forrefractive or therapeutic purposes; For the Non-Implanted Eye:

30. Have ophthalmic pathology at the Pre-operative Visit that compromises the patient'speripheral vision based on the Investigator's judgment.