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.
Evidence of active choroidal neovascularization (CNV), or treatment for CNV within the past six (6) months.
Diabetic retinopathy.
Retinal vascular diseases.
History of retinal detachment.