Actively Recruiting
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
Led by VisionCare, Inc. · Updated on 2026-02-10
76
Participants Needed
13
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 55 years of age or older.
- Have retinal findings of geographic atrophy or disciform scar with foveal involvement.
- Have evidence of cataract.
- Have best-corrected distance visual acuity 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.
- Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery using a 2.8X external telescope simulator.
- Have an anterior chamber depth of at least 2.5 mm in the eye scheduled for surgery.
- Be willing to participate in post-operative training for the implant.
- Review and sign informed consent.
- Have adequate understanding of the local language and willingness to comply with study requirements.
You will not qualify if you...
- Evidence of active choroidal neovascularization or treatment for it within the past six months.
- Any eye disease that compromises peripheral vision in the fellow eye.
- History of steroid-responsive intraocular pressure rise, uncontrolled glaucoma, or preoperative intraocular pressure over 22 mm Hg.
- Corneal guttata.
- Known sensitivity to post-operative medications.
- Significant communication impairment or severe neurological disorders.
- Previous intraocular or corneal surgery in the operative eye.
- Eye condition causing a tendency to rub the eye.
- Ophthalmic surgery within 30 days before implant surgery.
- Operative eye with myopia greater than 6.0 D, hyperopia greater than 4.0 D, axial length less than 21 mm, endothelial cell density less than 1600 cells/mm², or narrow angle less than Schaffer grade 2.
- Inflammatory ocular disease.
- Corneal stromal or endothelial dystrophies.
- Zonular weakness or lens instability.
- Diabetic retinopathy.
- Untreated retinal tears.
- Retinal vascular disease.
- Optic nerve disease.
- History of retinal detachment.
- Retinitis pigmentosa.
- Intraocular tumor.
- Participation in other investigational studies within 30 days or planned during this study.
- Employment or relative employment with the CRO, Sponsor, or Sponsor representative.
- Any condition that may pose significant risk, confound results, or interfere with participation as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 13 locations
1
UZ Brussel
Brussels, Belgium
Actively Recruiting
2
Centre d'Ophtalmologie Paradis-Monticelli
Marseille, France
Actively Recruiting
3
Hélios Ophtalmologie, Saint-Jean-de-Luz
Saint-Jean-de-Luz, France
Actively Recruiting
4
CHRU de Strasbourg
Strasbourg, France
Actively Recruiting
5
Augenklinik Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
Terminated
6
Universitätsklinikum Münster Klinik für Augenheilkunde
Münster, Germany
Actively Recruiting
7
Mater Misericordiae University Hospital
Dublin, Ireland
Actively Recruiting
8
Università degli Studi di Napoli Federico II
Naples, Italy
Actively Recruiting
9
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
Actively Recruiting
10
VISSUM
Alicante, Spain
Actively Recruiting
11
Institut OMIQ
Barcelona, Spain
Actively Recruiting
12
Hospital Universitario La Luz - Quirónsalud
Madrid, Spain
Actively Recruiting
13
Royal Victoria Hospital Belfast Health & Social Care Trust
Belfast, United Kingdom
Actively Recruiting
Research Team
A
Anne Roller, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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