What is the SING IMT 3X implant studying for Age-related Macular Degeneration?

The study is evaluating the safety and effectiveness of the SING IMT 3X implant in improving vision for patients with central vision loss due to end-stage Age-related Macular Degeneration. It aims to understand how well the device works and its safety over 12 months. The research is sponsored by VisionCare, Inc.

Who may be eligible for this Age-related Macular Degeneration clinical trial?

Adults aged 55 or older with central vision impairment from end-stage AMD and cataracts may be eligible. Participants must have specific vision levels and be willing to attend post-surgery vision training. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this Age-related Macular Degeneration clinical trial?

Study-related care, including the implant device and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 55Years +

All Genders

ID04796545

Study of the SING IMT 3X Implant to Improve Vision in Patients 55 and Older with Advanced Age-related Macular Degeneration

Led by VisionCare, Inc. · Updated on 2026-02-10

Participants Needed

Research Sites

95 weeks

Total Duration

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

Age: 55Years +

All Genders

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.

Research Team

Anne Roller, PhD

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Study of the SING IMT 3X Implant to Improve Vision in Patients 55 and Older with Advanced Age-related Macular Degeneration

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria