International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to … (NCT07164378) | Clinical Trial Compass
RecruitingNot Applicable
International Study of the SING IMTâ„¢ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD / PERSPECTIVE Study
France, Germany44 participantsStarted 2025-09-23
Plain-language summary
This study aims to expand the CE mark IFU of the SING IMTâ„¢ 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.
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Evidence of active choroidal neovascularization (CNV), or treatment for CNV within the past six (6) months.