International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD / PERSPECTIVE Study

Ki vehet részt

• Be 55 years of age or older
• Subjects with late-stage AMD; Have retinal findings of geographic atrophy or disciform scar with foveal involvement in both eyes
• Had cataract surgery (with IOL implantation in both eyes) at least 6 months prior to enrollment
• BCDVA no better than 20/80 and no worse than 20/800 in both eyes
• Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation
• Achieve using the ETS, at least 2-lines (10 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery
• Have an Anterior chambre depth (ACD) of at least 2.5 mm, measured from endothelium, in both eyes
• Have an ECD of at least 1600 cells per square mm in both eyes
• Be willing to participate in a postoperative training program for the use of the SING IMT™ implant
• Review and sign the IEC approved Informed Consent Form (ICF) prior to any clinical investigation-related procedures being performed
• Patient is registered with the national social security or equivalent in the country where consent is signed
• A woman is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:; 13, Not a woman of childbearing potential (WOCBP): A WOCBP who agrees to follow contraceptive guidance starting with the screening visit and through to the end of the study

Ki nem vehet részt

• Known sensitivity to post-operative medications
• Administration of any investigational product within 30 days prior to enrolment or planned participation in another clinical investigation during this study
• Bilateral Ocular Conditions (affecting both eyes):
• Retinal vascular diseases
• History of retinal detachment
• Patient predisposing to eye rubbing; Surgical Eye Conditions:
• Any history or current ocular or intraocular inflammation, infection, or edema, including but not limited to: - Uveitis, iritis, keratitis, keratouveitis, microbial keratoconjunctivitis
• Iris abnormalities, including but not limited to: Transillumination defects (e.g., pigment dispersion syndrome), aniridia, iris neovascularization
• Optic Nerve Disease; Systemic or Other General Conditions:
• A history of steroid-induced IOP elevation uncontrolled, glaucoma, or preoperative IOP >22 mmHg
• Significant communication impairment or severe neurological disorders
• Any condition or situation that, in the opinion of the investigator, may:; Put the subject at significant risk,; Confound the clinical investigation results, or; Interfere significantly with the subject's participation in the study
• Evidence of active choroidal neovascularization (CNV), or treatment for CNV within the past six (6) months
• Diabetic retinopathy
• Retinitis pigmentosa
• Intraocular tumor
• Corneal Stromal or Endothelial Dystrophies (for example corneal guttata)Corneal guttata
• Narrow angle (i.e., < Schaffer grade 2)
• Axial length <21 mm or >26 mm
• Plate haptic shape IOL implanted
• Vitrectomized eye
• Zonular weakness, instability, presence of pseudoexfoliation
• Any IOL already implanted in the sulcus
• Presence of toric or multifocal IOL types
• Individuals under legal care (e.g., incarcerated patients or those under legal guardianship) who are unable to understand and provide informed consent