RecruitingNAINTERVENTIONAL

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

This study is investigating a new, tiny telescope implant called SING IMT 3X for people in the UK who have severe, ‘end-stage’ age-related macular degeneration (AMD). AMD causes central blurry vision, making it hard to see faces or read. The aim is to check if this implant is safe and if it can help improve vision for those affected. Patients who are suitable will have the implant placed during a routine cataract operation. After surgery, they will attend regular eye check-ups and vision training sessions for 12 months to help them learn how to use their improved vision. This study will help doctors understand how well the implant works in real-world settings.

At a glance

Status

Recruiting

Phase

Sponsor

VisionCare, Inc.

Enrolment target

Start

13 Sep 2022

Estimated completion

01 Dec 2028

AMD Age-Related Macular Degeneration

What is this study about?

This study is looking into a new type of treatment for people living with severe age-related macular degeneration, often called AMD. AMD is a common eye condition that affects the central part of your vision, making it difficult to do everyday tasks like reading, recognising faces, or driving. This study focuses on people with 'end-stage' AMD, meaning their vision loss is quite advanced.

The treatment being studied is a tiny device called the SING IMT 3X. Think of it like a miniature telescope that is implanted inside the eye. The idea behind it is to magnify images onto a healthier part of the retina (the light-sensitive layer at the back of your eye) so that your central vision can be improved. This study aims to find out if this implant is both safe to use and effective at helping to improve vision for people with severe AMD.

This is a 'post-market' study, which means the device may already be available in some places, but researchers are gathering more information about its performance and safety in a broader group of people. If you qualify and choose to take part, you would have the tiny telescope placed during a routine cataract operation. Following the surgery, you’d receive ongoing support, including regular eye appointments and special vision training to help you get the most out of the implant and adjust to your improved vision.

Key takeaways

This study is for people with severe age-related macular degeneration (AMD).
It tests a tiny telescope implant (SING IMT) to improve central vision.
Participation involves surgery and about 12 months of follow-up care and vision training.
You must meet specific vision and health criteria to be eligible.
The aim is to understand if the implant is safe and effective in real-world use.

Who may be eligible?

To be considered for this study, you would generally need to be 55 years old or older and have certain signs of advanced AMD in your eyes, such as specific changes detected by eye scans. You would also need to have cataracts, which is a common clouding of the eye's natural lens. Your vision in both eyes would typically be quite poor, generally not better than 20/80 and not worse than 20/800.

Critically, before the actual implant, you'd undergo a special vision test using a trial magnifying device. To go forward with the surgery, this test must show that your vision in the eye to be treated would improve by a certain amount (at least 5 letters on an eye chart). You also need to have good enough side vision in your other eye.

There are also reasons why you might not be able to join. For example, if you've had recent treatment for another serious AMD-related condition, have certain other eye problems like uncontrolled glaucoma, or have had other eye surgeries in the eye to be treated, you wouldn't be eligible. It's also important that you're willing to commit to the follow-up appointments and vision training.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 55 years old or older?
Do you have severe AMD and cataracts?
Is your central vision quite poor in both eyes?
Would your central vision improve when tested with a special magnifying lens?
Are you able to commit to follow-up eye appointments and vision training for about a year?
Do you not have other serious eye conditions, like uncontrolled glaucoma?

Answer every question to see your result.

What does participation involve?

If you decide to take part and meet all the eligibility criteria, you would first sign a consent form. You'd then have an out-patient surgery to implant the SING IMT device, which would be done at the same time as a routine cataract operation. After the surgery, you'll have regular eye check-ups, typically over a period of 12 months, to monitor your eye health and the implant's effectiveness.

Crucially, you would also attend 6 to 10 additional visits with a low vision specialist. These are dedicated training sessions to help you learn how to use your vision with the new implant effectively. The study team will carefully monitor any potential complications, known as 'adverse events', and track any medications you are taking throughout the study period. The total duration of your active participation, including all follow-up appointments, is about 12 months.

Potential risks and benefits

Taking part in this study could potentially offer a significant benefit by improving your central vision, which might make everyday tasks easier. However, like any surgical procedure, there are potential risks, such as infection, bleeding, or issues with the implant itself. The study will carefully monitor for any complications. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UZ Brussel
Verified postcode
Brussels, Belgium· Recruiting
Centre d'Ophtalmologie Paradis-Monticelli
Verified postcode
Marseille, France· Recruiting
Hélios Ophtalmologie, Saint-Jean-de-Luz
Verified postcode
Saint-Jean-de-Luz, France· Recruiting
CHRU de Strasbourg
Verified postcode
Strasbourg, France· Recruiting
Augenklinik Städtisches Klinikum Karlsruhe
Verified postcode
Karlsruhe, Germany· Terminated
Universitätsklinikum Münster Klinik für Augenheilkunde
Verified postcode
Münster, Germany· Recruiting
Mater Misericordiae University Hospital
Verified postcode
Dublin, Ireland· Recruiting
Università degli Studi di Napoli Federico II
Verified postcode
Naples, Italy· Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Verified postcode
Roma, Italy· Recruiting
VISSUM
Verified postcode
Alicante, Spain· Recruiting
Institut OMIQ
Verified postcode
Barcelona, Spain· Recruiting
Hospital Universitario La Luz - Quirónsalud
Verified postcode
Madrid, Spain· Recruiting

Common questions

What is Age-related Macular Degeneration (AMD)?

AMD is a common eye condition that causes blurry vision or a blind spot in the centre of your sight, making it hard to see fine details.

What is the SING IMT 3X implant?

It's a tiny telescope that is surgically placed inside the eye to magnify what you see and help improve central vision for people with severe AMD.

Will I have surgery if I join this study?

Yes, if eligible, you would undergo an out-patient surgery to implant the device, typically combined with cataract removal.

How long will I be involved in the study?

Your participation, including follow-up appointments and vision training, will last for about 12 months in total.

What is vision rehabilitation?

This is a type of training where specialists help you learn how to use your vision more effectively, especially after an implant like the one being studied.

How to find out more

Anne Roller, PhD

clinicals@medevise-consulting.com + 33 (0)3 88 30 88 11 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.