Actively Recruiting
Post-marketing Clinical Study of the SING IMT System Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration and Central Vision Loss
Led by VisionCare, Inc. · Updated on 2026-02-10
76
Participants Needed
13
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant to improve vision in patients aged 55 years and older with central vision impairment caused by end-stage Age-related Macular Degeneration (AMD). This is a prospective, multicenter, open-label study where all eligible patients receive the implant and are followed for one year. The study aims to determine how well the device works and its safety during this period. Participants who qualify will have the SING IMT 3X device implanted during routine cataract surgery. Eligibility is confirmed by testing vision improvement with an external telescope simulator before surgery. After implantation, patients will attend 6 to 10 vision training sessions with a low-vision specialist to help adapt to the device. Surgeons will also assess the usability and satisfaction of the implant during the study. Throughout the 12-month follow-up, participants will have regular eye exams to monitor vision and eye health in both eyes. The study will track any surgical complications, adverse events, and medication use from the start to the end of the study. Researchers will measure improvements in visual acuity and the safety of the implant system, including the delivery method used during surgery.
CONDITIONS
Brief 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 as shown by fluorescein angiography or OCT.
- 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 the 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 the informed consent form prior to study procedures.
- 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 CNV 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 IOP over 22 mm Hg.
- Presence of corneal guttata.
- Known sensitivity to post-operative medications.
- Significant communication impairment or severe neurological disorders.
- Previous intraocular or corneal surgery in the operative eye.
- Ocular condition that predisposes to eye rubbing.
- Ophthalmic surgery within 30 days before implant surgery.
- Specific eye measurements outside set limits, including myopia >6.0 D, hyperopia >4.0 D, axial length <21 mm, endothelial cell density <1600 cells/mm², or narrow angle.
- Inflammatory ocular disease.
- Corneal dystrophies including guttata.
- Zonular weakness or instability of the lens.
- Diabetic retinopathy.
- Untreated retinal tears.
- Retinal vascular disease.
- Optic nerve disease.
- History of retinal detachment.
- Retinitis pigmentosa.
- Intraocular tumor.
- Use of any investigational product within 30 days before enrollment or participation in another study during this trial.
- Employment or close relation to the study sponsor or research organization.
- Any condition or situation that may increase risk or interfere with study participation as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery
Participants undergo outpatient surgery to implant the SING IMT System during routine cataract surgery, followed by immediate post-operative care including usability and satisfaction assessments by the surgeon.
1 surgery visit and immediate post-operative assessments
Duration - Up to 12 months
Participants undergo ophthalmic evaluations in both eyes at regular intervals and complete vision training with a low vision specialist.
Regular ophthalmic visits plus 6 to 10 vision training visits
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
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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