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

Korábbi kezelés

• 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.

Más betegség

• 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.

Egyéb

• 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.

• 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