At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- SING IMT(TM) System, model NG SI IMT 3X (device)
- How long the study runs
- Study runs about 75 months (dates as stated)
- About the drug or intervention
- SING IMT(TM) System, model NG SI IMT 3X — device: 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 55 Years and over
- Who
- All
- Number of participants
- 68
- Started
- 2022-09-13
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for amd
- • NA - 68 participants
- • 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)
Who can take part?
- • Ages 55 Years and over
- • Diagnosed with amd
Where?
- • Belfast - Royal Victoria Hospital Belfast Health & Social Care Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 55 Years and over
- Who can join: All genders
What the study is looking for
- ✓Be 55 years of age or older.
- ✓Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein...
- ✓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...
- ✓Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
Who cannot take part
- ✗Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV...
- ✗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.
See the full criteria
Where Is This Study? (1 UK site)
Royal Victoria Hospital Belfast Health & Social Care Trust
Belfast, United Kingdom
