The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD). Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.
This is an interventional, prospective, multicenter, open label, single group assignment Post-Market Clinical Follow-up (PMCF) study in men and women \>=55 years with central vision impairment associated with end-stage AMD. Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study. Baseline visual acuity of the study subjects will be assessed with a 2.8X external telescope simulator (ETS) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts to determine if they are likely to benefit from receiving the IMT. To be included in the study and to proceed with the surgery, subjects must achieve, using the ETS, at least a one line (5 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery. Subjects not meeting these criteria will be excluded from the study. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Postoperatively, the surgeon will complete a usability and satisfaction questionnaire after each implantation procedure. The patients will undergo ophthalmic evaluations in both eyes at regular intervals for up to 12 months. The subjects will also be required to undergo 6 to 10 additional visits for vision training with a low vision specialist. Surgical complications, as well as all Adverse Event (AEs) and use of medications will be monitored from baseline to the end of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
76
The SING IMT 3X implant is a visual prosthetic implantable device, which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with bilateral, end-stage age-related macular degeneration.
UZ Brussel
Brussels, Belgium
RECRUITINGCentre d'Ophtalmologie Paradis-Monticelli
Marseille, France
RECRUITINGHélios Ophtalmologie, Saint-Jean-de-Luz
Saint-Jean-de-Luz, France
RECRUITINGCHRU de Strasbourg
Strasbourg, France
RECRUITINGAugenklinik Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
TERMINATEDUniversitätsklinikum Münster Klinik für Augenheilkunde
Münster, Germany
RECRUITINGMater Misericordiae University Hospital
Dublin, Ireland
RECRUITINGUniversità degli Studi di Napoli Federico II
Naples, Italy
RECRUITINGFondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
RECRUITINGVISSUM
Alicante, Spain
RECRUITING...and 3 more locations
Safety of the SING IMT System, model NG SI IMT 3X, including its delivery system
The percent decrease in endothelial cell density (ECD).
Time frame: 12 months
Incision size needed for device implantation
Incision size will not exceed 8.0 mm (non-inferiority assumption) in 75% of surgeries
Time frame: 12 moths
Surgical complications
AEs and serious adverse events
Time frame: 12 moths
Improvement in near and distance best corrected visual acuity (BCVA) in implanted eyes.
Near and distance BCVA will show an improvement of ≥2 lines in the ETDRS chart in at least 50% (non-inferior to 50%) of the implanted eyes at 12 months post implantation.
Time frame: 12 months
Usability of SING IMT System, including delivery system
Surgeon will complete a usability and satisfaction questionnaire
Time frame: 12 months
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