Prospective, MulticEnter, Randomized, 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
This study aims to expand the CE mark IFU of the SING IMT™ to pseudophakic (patients with an intraocular lents) patients with late stage of AMD (Age-Related Macular Degeneration) and bilateral central vision impairment. This randomized, international, multicenter study will evaluate the safety and efficacy of the device in this patient group. Findings will support regulatory submissions, clinical decision-making, and potential label expansion.
• 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