Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration

Recruiting now · Not applicable

Conditions studied: AMD, Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT04796545

Run by

VisionCare, Inc.

People needed

76

Starts

2022-09-13

Expected to finish

2028-12-01

Last updated by the study team

2026-02-10

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be 55 years of age or older.
• Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.
• Have evidence of cataract.
• Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes.
• Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
• Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using Samsara's 2.8X external telescope simulator (ETS, supplied separately).
• Have an ACD of at least 2.5 mm in the eye scheduled for surgery.
• Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant.
• Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
• Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements.

You may not qualify if…

• Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
• Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
• A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP>22 mm Hg.
• Corneal guttata.
• Known sensitivity to post-operative medications.
• Significant communication impairment or severe neurological disorders.
• Have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes.
• An ocular condition that predisposes the patient to eye rubbing.
• Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery.
• Patients for whom the planned operative eye has:
• Myopia > 6.0 D
• Hyperopia > 4.0 D
• Axial length < 21 mm
• Endothelial cell density < 1600 cells per square mm
• Narrow angle, i.e., < Schaffer grade 2.
• Inflammatory ocular disease.
• Cornea stromal or endothelial dystrophies, including guttata.
• Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
• Diabetic retinopathy.
• Untreated retinal tears.
• Retinal vascular disease.
• Optic nerve disease.
• A history of retinal detachment.
• Retinitis pigmentosa.
• Intraocular tumor.

Where it is running

• Royal Victoria Hospital Belfast Health & Social Care Trust — Belfast, United Kingdom (enrolling)
• Centre d'Ophtalmologie Paradis-Monticelli — Marseille, France (enrolling)
• Hélios Ophtalmologie, Saint-Jean-de-Luz — Saint-Jean-de-Luz, France (enrolling)
• CHRU de Strasbourg — Strasbourg, France (enrolling)
• UZ Brussel — Brussels, Belgium (enrolling)
• Universitätsklinikum Münster Klinik für Augenheilkunde — Münster, Germany (enrolling)
• Mater Misericordiae University Hospital — Dublin, Ireland (enrolling)
• Università degli Studi di Napoli Federico II — Naples, Italy (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy (enrolling)
• VISSUM — Alicante, Spain (enrolling)
• Institut OMIQ — Barcelona, Spain (enrolling)
• Hospital Universitario La Luz - Quirónsalud — Madrid, Spain (enrolling)
• Augenklinik Städtisches Klinikum Karlsruhe — Karlsruhe, Germany

Full record on ClinicalTrials.gov

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