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

Korábbi kezelés

• Known sensitivity to post-operative medications.
• 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.
• Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery.
• 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.

Más betegség

• A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP>22 mm Hg.
• Significant communication impairment or severe neurological disorders.
• An ocular condition that predisposes the patient to eye rubbing.
• Inflammatory ocular disease.
• Retinal vascular disease.
• Optic nerve disease.
• A history of retinal detachment.
• 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.

Egyéb

• Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
• Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
• Corneal guttata.
• 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.
• Cornea stromal or endothelial dystrophies, including guttata.
• Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
• Diabetic retinopathy.
• Untreated retinal tears.
• Retinitis pigmentosa.
• Intraocular tumor.
• Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.

• Be 55 years of age or older.
• Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.
• Have evidence of cataract.
• Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes.
• Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
• Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using Samsara's 2.8X external telescope simulator (ETS, supplied separately).
• Have an ACD of at least 2.5 mm in the eye scheduled for surgery.
• Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant.
• Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
• Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements.