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RekrutierungNAINTERVENTIONELL

Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

This research is investigating a new treatment called i-Lumen AMD for a common eye condition known as age-related macular degeneration (AMD). Specifically, it's for people with intermediate to advanced 'dry' AMD, where there isn't any leaking or bleeding in the eye. The i-Lumen AMD device uses a very small electric current, applied near the eye. The main goals of the study are to find out if this treatment is safe and if it can help stop the condition from getting worse. Participants will have treatments over 11 months, followed by several months of check-ups to see how they're doing. This study hopes to offer a new way to manage AMD, a condition that can affect your eyesight as you get older.

Auf einen Blick

Status
Rekrutierung
Phase
NA
Sponsor
i-Lumen Scientific AUS PTY LTD
Einschreibeziel
100
Starten
07 May 2025
Geschätzte Fertigstellung
31 Dez 2029

Worum geht es in dieser Studie?

This study is exploring a new way to help people with a common eye condition called Age-related Macular Degeneration (AMD). If you have AMD, it affects the central part of your vision, which is important for things like reading and recognising faces. This study is specifically for a type of 'dry' AMD, which means there isn't any leaking or bleeding in the eye.

The new treatment being tested is called i-Lumen AMD. It involves using a very gentle electrical current, applied near the eye, to see if it can help the way your eye works. Researchers want to understand if this treatment is safe for people to use and if it can effectively slow down the progression of AMD, especially in those with intermediate to advanced stages of the condition. They hope this could offer a new option for managing sight.

The study will follow participants closely. If you take part, you'll have a course of treatments over approximately 11 months, followed by several months of regular check-ups. These check-ups are important for the medical team to see how your eyes are responding and to make sure the treatment is safe for you. This kind of research is vital for finding new and better ways to help people living with eye conditions.

Wichtige Erkenntnisse

  • This study is testing a new 'microcurrent' device for 'dry' AMD.
  • It aims to check if the i-Lumen AMD device is safe and effective.
  • The study is for people with intermediate to advanced dry AMD.
  • Participation involves regular treatments for about 11 months, then check-ups.
  • The total time commitment for the study is around 14 months.
  • It could potentially offer a new way to manage AMD, but it's a research study.

Wer könnte berechtigt sein?

To be considered for this study, you would need to have specific findings in your eye exams consistent with AMD, particularly with at least one 'large druse' – which are small yellow deposits under the retina. Your eyesight would also need to fall within a certain range, meaning it's not too good and not too bad, as measured by standard eye charts.

There are also reasons why you might not be able to join. For example, if you have certain electronic devices implanted in your body, like a pacemaker or some types of hearing or vision implants, you wouldn't be able to take part. Similarly, if you have metal implants close to where the treatment would be applied, or a history of seizures, severe dry eye, or uncontrolled diabetes, you wouldn't be suitable.

The study also cannot include individuals who have other eye conditions that might be confused with AMD, or if you've recently had other eye treatments like specific laser therapies or injections for a different type of AMD. If you smoke heavily or have done so recently, that would also exclude you.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Do you have a diagnosis of intermediate to advanced 'dry' AMD?
  2. Do you have a specific type of yellow deposit (called 'drusen') in your eye?
  3. Is your eyesight within a specific range (not too good, not too poor)?
  4. Do you have any implanted electronic devices like a pacemaker or hearing implant?
  5. Do you have any metal implants near your eye or neck?
  6. Are you a heavy smoker or have you been in the last 5 years?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

If you decide to take part in this study, you would first have an initial period of treatments, followed by monthly follow-up treatments for about 11 months in total. This means you would be having treatment regularly over this period.

After your treatment period finishes, you would continue to visit the clinic once a month for another three months. So, in total, you could expect to be involved in the study for about 14 months. These monthly visits are for the medical team to check your eyes, see how you're responding to the treatment, and make sure everything is okay.

Potenzielle Risiken und Vorteile

Participating in this study might offer a potential benefit of slowing down the progression of your AMD, but it's important to remember this is a new treatment, and its effectiveness is still being investigated. As with any medical procedure, there could be risks or side effects, although the study is designed to be as safe as possible. You will be closely monitored throughout. It's important to know that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Standorte (13)

  • Retina Consultants San Diego
    Verifizierte Postleitzahl
    Poway, United States· Rekrutierung
  • Retina Consultants PC
    Verifizierte Postleitzahl
    Manchester, United States· Rekrutierung
  • University Retina & Macula Associates
    Verifizierte Postleitzahl
    Lemont, United States· Rekrutierung
  • Sierra Eye Associates
    Verifizierte Postleitzahl
    Reno, United States· Noch nicht rekrutiert
  • Retina Associates of Cleveland
    Verifizierte Postleitzahl
    Beachwood, United States· Rekrutierung
  • Texas Retina Associates
    Verifizierte Postleitzahl
    Fort Worth, Vereinigte Staaten· Rekrutierung
  • Tyler Retina Research Insitute
    Verifizierte Postleitzahl
    Tyler, United States· Rekrutierung
  • Cerulea
    Verifizierte Postleitzahl
    East Melbourne, Australia· Aktiv, aber nicht rekrutierend
  • Auckland Eye Limited
    Verifizierte Postleitzahl
    Remuera, New Zealand· Rekrutierung
  • Queens University Belfast / Belfast City Hospital
    Verifizierte Postleitzahl
    Belfast, Vereinigtes Königreich· Rekrutierung
  • King's College Krankenhaus
    Verifizierte Postleitzahl
    London, Vereinigtes Königreich· Rekrutierung
  • London North West University Healthcare
    Verifizierte Postleitzahl
    Middlesex, United Kingdom· Rekrutierung

Häufige Fragen

What is Age-related Macular Degeneration (AMD)?

AMD is an eye condition that affects the macula, the central part of your retina, which is responsible for sharp eyesight needed for reading and recognising faces. It often develops as people get older.

What does 'nonexudative' mean?

This simply means 'dry' AMD. It's the most common type and doesn't involve any leaking or bleeding in the eye, unlike 'wet' AMD.

How does the i-Lumen AMD treatment work?

The i-Lumen AMD device uses a very gentle electrical current applied near the eye. The researchers are trying to see if this microcurrent can help improve or stabilize the condition of the eye in people with AMD.

Muss ich bezahlen, um an der Studie teilzunehmen?

No, you should not have to pay for any study-related treatments or visits. This will be explained fully by the study team.

Kann ich die Teilnahme beenden, wenn ich meine Meinung ändere?

Yes, taking part in a clinical trial is always voluntary. You can choose to leave the study at any time, for any reason, and it will not affect the medical care you receive.

Wie Sie mehr erfahren können

Meredith Mundy

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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