A Study of the SING IMT in an Israeli Cohort

Prior treatment

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

Other illness

• 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 any of the following conditions at the Pre-operative Visit:
  • Stargardt macular dystrophy;
  • Diabetic retinopathy;
  • Untreated retinal tears;
  • Retinal vascular disease;
  • Optic nerve disease;
  • History of retinal detachment;
  • Intraocular tumor;
  • Retinitis pigmentosa;
  • 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;
• 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;
• Have a history of corneal stromal or endothelial dystrophies, including guttata;
• Ongoing Inflammatory ocular disease 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;

Other

• For Both Eyes:
• 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 circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety;
• 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;
• Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit;

• For Both Eyes:
• Be at least 55 years of age at the Pre-operative Visit;
• Have ETDRS BCDVA 0.6 to 1.6 logMAR (20/80 to 20/800) at the Pre-operative Visit;
• Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography (FA) or OCT;
• Have an Endothelial Cell Density (ECD) above 1800 cells per millimeter;
• Have central anterior chamber depth (ACD) >2.5 mm from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens at the Pre-operative Visit;
• Agree to participate in post-operative visual training
  • For the Implanted Eye:
• Have evidence of visually significant cataract at the Pre-operative Visit;
• Agree to undergo pre-operative assessment with low vision specialists (optometrist, occupational therapist or other professional with low vision experience) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment
  • For the Non-Implanted Eye:
  • -Have adequate peripheral vision at the Pre-operative Visit to allow navigation.