A Study of the SING IMT in an Israeli Cohort

Exclusion Criteria

• •For Both Eyes:
• •Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
• •Have evidence of bilateral active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
• •Have any of the following conditions at the Pre-operative Visit:
• •1. Stargardt macular dystrophy;
• •2. Diabetic retinopathy;
• •3. Untreated retinal tears;
• •4. Retinal vascular disease;
• •5. Optic nerve disease;
• •6. History of retinal detachment;
• •7. Intraocular tumor;
• •8. Retinitis pigmentosa;
• •9. History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP \>22 mmHg at the Pre-operative Visit;
• •Have known allergy to post-operative medications;
• •History of eye rubbing or an ocular condition that predisposes subject to eye rubbing;
• •Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit;
• •Have any circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety;
• •Any systemic disease or clinical evidence of any condition at the Pre-operative Visit which would make the subject in the opinion of the investigator unsuitable for the study;
• •Concurrent participation or prior participation in any investigative drug or device study within last 30 days prior to Pre-operative Visit.
• •For the Implanted Eye:
• •Have a history of corneal stromal or endothelial dystrophies, including guttata;
• •Have Myopia \> 6.0 D or Hyperopia \> 4.0 D by Manifest Refraction at the Pre-operative Visit;
• •Have an Axial Length (AL) \< 21 mm at the Pre-operative Visit;
• •Have a narrow angle defined as \< grade 2 on the Schaffer scale at the Pre-operative Visit;
• •Ongoing Inflammatory ocular disease at the Pre-operative Visit;
• •Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit;
• •Have any condition at the Pre-operative Visit which in the judgement of the Investigator indicates that the haptics cannot be placed within the capsular bag during surgery;
• •Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes;
• •For the Non-Implanted Eye:
• •Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.